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Long-Term Non-Interventional Latanoprost Study (LYNX)

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ClinicalTrials.gov Identifier: NCT01265719
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Glaucoma
Ocular Hypertension
Intervention Other: No intervention other than routine medical care
Enrollment 175

Recruitment Details A total of 175 patients were enrolled into the study in 14 countries in Europe and South America: 102 in the latanoprost treatment group and 73 in the non-Prostaglandin (PG) treatment group.
Pre-assignment Details No significant events prior to group assignment are to be reported. This was a non-interventional, prospective, longitudinal cohort study. Pediatric patients with glaucoma or elevated intra ocular pressure (IOP) were enrolled into 2 groups: Latanoprost-treated patients and non-PG treated patients.
Arm/Group Title Latanoprost Group Non Prostaglandin Group
Hide Arm/Group Description

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.

Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Period Title: Overall Study
Started 102 73
Completed 88 60
Not Completed 14 13
Reason Not Completed
Does not meet entrance criteria             0             3
Other reasons             2             0
Withdrawal by Subject             8             3
Lost to Follow-up             2             7
Adverse Event             2             0
Arm/Group Title Latanoprost Group Non Prostaglandin Group Total
Hide Arm/Group Description

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.

Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Total of all reporting groups
Overall Number of Baseline Participants 102 73 175
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 73 participants 175 participants
8.8  (4.96) 6.4  (4.76) 7.8  (5.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 73 participants 175 participants
Female
48
  47.1%
28
  38.4%
76
  43.4%
Male
54
  52.9%
45
  61.6%
99
  56.6%
1.Primary Outcome
Title Change From Baseline to Last Available Observation in Best Corrected Visual Acuity (BCVA) (Snellen or Equivalent)
Hide Description Patients familiar with the letters of the alphabet were evaluated using Snellen visual acuity. Patients who were unable or unfamiliar with the letters of the alphabet were evaluated using charts made up of numbers, pictures (eg, Schering’s Children’s Eye Chart or Allen Cards), E’s, or Landolt’s broken rings, and other methods which were equivalent to Snellen acuity eg, HOTV testing).
Time Frame Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis population included all enrolled subjects.
Arm/Group Title Latanoprost Group Non Prostaglandin Group
Hide Arm/Group Description:

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.

Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Overall Number of Participants Analyzed 102 73
Least Squares Mean (Standard Error)
Unit of Measure: logMar
<5 years Number Analyzed 4 participants 16 participants
0.25  (0.17) -0.07  (0.09)
5 to <18 years Number Analyzed 69 participants 36 participants
0.01  (0.02) 0.04  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Latanoprost Group, Non Prostaglandin Group
Comments <5 years
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1126
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
-0.09 to 0.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.20
Estimation Comments Change from baseline to last available observation in BCVA was analyzed using an ANCOVA model with fixed effect for treatment group with baseline BCVA value as covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Latanoprost Group, Non Prostaglandin Group
Comments 5 to <18 years
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4840
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.12 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.04
Estimation Comments Change from baseline to last available observation in BCVA was analyzed using an ANCOVA model with fixed effect for treatment group with baseline BCVA value as covariate.
2.Secondary Outcome
Title Number of Participants With Clinically Meaningful Change in Refractive Error
Hide Description The refractive error [cycloplegic where appropriate (eg, those unable to cooperate with manifest refraction)] were determined at the baseline visit and assessed at the following visits.
Time Frame Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis population included all enrolled subjects.
Arm/Group Title Latanoprost Group Non Prostaglandin Group
Hide Arm/Group Description:

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.

Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Overall Number of Participants Analyzed 102 73
Measure Type: Number
Unit of Measure: Participants
8 2
3.Secondary Outcome
Title Change From Baseline to Last Available Observation in Horizontal Corneal Diameter (by Caliper and/or Ruler)
Hide Description The horizontal corneal diameter was measured along the horizontal meridians. Diameter was measured using either a series of transparent plates with holes of different diameters in quarter-millimeter increments or with calibrated calipers compared against a ruler. When using calipers, the corneal diameter measurement was taken from limbus to a similar point 180° away at the opposite limbus. When not examining the children with anesthesia, it was recommended to use a tape measure across the head while measuring horizontal corneal diameter by photographic method.
Time Frame Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis population included all enrolled subjects.
Arm/Group Title Latanoprost Group Non Prostaglandin Group
Hide Arm/Group Description:

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.

Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Overall Number of Participants Analyzed 102 73
Least Squares Mean (Standard Error)
Unit of Measure: mm
<5 years Number Analyzed 21 participants 29 participants
0.33  (0.22) 0.37  (0.19)
5 to <18 years Number Analyzed 68 participants 36 participants
0.08  (0.12) 0.05  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Latanoprost Group, Non Prostaglandin Group
Comments <5 years
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9020
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.63 to 0.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.30
Estimation Comments Change from baseline to last available observation in HCD was analyzed using an ANCOVA model with fixed effect for treatment group with baseline HCD value as covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Latanoprost Group, Non Prostaglandin Group
Comments 5 to <18 years
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8826
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.37 to 0.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.20
Estimation Comments Change from baseline to last available observation in HCD was analyzed using an ANCOVA model with fixed effect for treatment group with baseline HCD value as covariate.
4.Secondary Outcome
Title Change From Baseline to Last Available Observation in Intraocular Pressure (IOP)
Hide Description IOP was preferably measured using 1 of 3 applanation-contact methods: Goldmann applanation tonometry, Perkins tonometry, or TonoPen® (tonometry). iCare® rebound tonometer was also allowed if it was used consistently throughout the study.
Time Frame Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis population included all enrolled subjects.
Arm/Group Title Latanoprost Group Non Prostaglandin Group
Hide Arm/Group Description:

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.

Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Overall Number of Participants Analyzed 102 73
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
<5 years Number Analyzed 21 participants 30 participants
-1.01  (0.94) 0.61  (0.78)
5 to <18 years, IOP <21mmHg at Baseline Number Analyzed 65 participants 33 participants
1.52  (0.43) 1.62  (0.61)
5 to <18 years, IOP ≥21mmHg at Baseline Number Analyzed 10 participants 4 participants
-4.26  (1.22) 2.40  (1.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Latanoprost Group, Non Prostaglandin Group
Comments <5 years
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -1.62
Confidence Interval (2-Sided) 95%
-4.13 to 0.89
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.25
Estimation Comments Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Latanoprost Group, Non Prostaglandin Group
Comments 5 to <18 years (IOP <21mmHg at Baseline)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8940
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-1.59 to 1.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.75
Estimation Comments Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Latanoprost Group, Non Prostaglandin Group
Comments 5 to <18 years (IOP ≥21mmHg at Baseline)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0184
Comments [Not Specified]
Method ANCOVA
Comments The results were interpreted with caution because of the very small sample size of non-PG treatment group (n=4).
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -6.66
Confidence Interval (2-Sided) 95%
-11.95 to -1.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.41
Estimation Comments Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.
5.Secondary Outcome
Title Cup-to-disc Ratio (for Assessment of Optic Nerve Changes/Structures) - Number of Participants With Clinically Significant Deterioration in Cup/Disc Ratios
Hide Description The cup/disc ratio was recorded horizontally and vertically for each examination, and reported in 0.1 increments.
Time Frame Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis population included all enrolled subjects.
Arm/Group Title Latanoprost Group Non Prostaglandin Group
Hide Arm/Group Description:

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.

Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Overall Number of Participants Analyzed 102 73
Measure Type: Number
Unit of Measure: Participants
1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Latanoprost Group, Non Prostaglandin Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.999
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-13.97 to 15.90
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Visual Field Defects - Number of Participants With Clinically Significant Deterioration of Visual Field Defects.
Hide Description A visual field examination was performed for those patients who can cooperate automated perimetry utilizing a threshold program. All visual fields was conducted utilizing the standard white background with a Goldmann size III white stimulus. For those patients who can not perform formal visual field testing, then field to confrontation test was used for younger, non-verbal children, central, steady and maintains fixation was used.
Time Frame Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis population included all enrolled subjects.
Arm/Group Title Latanoprost Group Non Prostaglandin Group
Hide Arm/Group Description:

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.

Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Overall Number of Participants Analyzed 102 73
Measure Type: Number
Unit of Measure: Participants
1 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Latanoprost Group, Non Prostaglandin Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.999
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-15.32 to 14.55
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Iris Color Darkening
Hide Description Changes from baseline in iris color were reported at each follow-up visit. Photographs were taken at the discretion of investigators as per standard of care.
Time Frame Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis population included all enrolled subjects.
Arm/Group Title Latanoprost Group Non Prostaglandin Group
Hide Arm/Group Description:

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.

Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Overall Number of Participants Analyzed 102 73
Measure Type: Number
Unit of Measure: Participants
4 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Latanoprost Group, Non Prostaglandin Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.999
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
-13.78 to 16.09
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Localized Pigmentation (Nevi or Freckles) of Conjunctiva, Iris and Choroid
Hide Description Changes from baseline in localized pigmentation (nevi and freckles) of the conjunctiva, iris and choroid were reported at each follow-up visit. Photographs were taken at the discretion of investigators as per standard of care.
Time Frame Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis population included all enrolled subjects.
Arm/Group Title Latanoprost Group Non Prostaglandin Group
Hide Arm/Group Description:

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.

Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Overall Number of Participants Analyzed 102 73
Measure Type: Number
Unit of Measure: Participants
3 3
9.Secondary Outcome
Title Eyelash Darkening/Thickening
Hide Description Changes from baseline in eyelash darkening/thickening/lengthening were reported at each follow-up visit. Photographs were taken at the discretion of investigators as per standard of care.
Time Frame Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis population included all enrolled subjects.
Arm/Group Title Latanoprost Group Non Prostaglandin Group
Hide Arm/Group Description:

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.

Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Overall Number of Participants Analyzed 102 73
Measure Type: Number
Unit of Measure: Participants
3 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Latanoprost Group, Non Prostaglandin Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6414
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
-13.39 to 16.48
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline to Last Available Observation in Length of Eyelash (by Caliper and/or Ruler)
Hide Description The longest eyelash (mm) measured by caliper or ruler was recorded at baseline and each follow-up visit.
Time Frame Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis population included all enrolled subjects.
Arm/Group Title Latanoprost Group Non Prostaglandin Group
Hide Arm/Group Description:

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.

Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Overall Number of Participants Analyzed 102 73
Least Squares Mean (Standard Error)
Unit of Measure: mm
<5 years Number Analyzed 19 participants 28 participants
1.14  (0.40) 0.53  (0.33)
5 to <18 years Number Analyzed 69 participants 35 participants
0.44  (0.19) 0.65  (0.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Latanoprost Group, Non Prostaglandin Group
Comments <5 years
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2437
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
-0.43 to 1.65
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.52
Estimation Comments Change from baseline to last available observation in longest lash length (LLL) was analyzed using an ANCOVA model with fixed effect for treatment group with baseline LLL value as covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Latanoprost Group, Non Prostaglandin Group
Comments 5 to <18 years
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5199
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.85 to 0.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.32
Estimation Comments Change from baseline to last available observation in LLL was analyzed using an ANCOVA model with fixed effect for treatment group with baseline LLL value as covariate.
11.Secondary Outcome
Title Change From Baseline to Last Available Observation in Corneal Thickness (Pachymeter)
Hide Description Central corneal thickness was measured using a calibrated pachymeter, preferably an ultrasonic pachymeter.
Time Frame Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis population included all enrolled subjects.
Arm/Group Title Latanoprost Group Non Prostaglandin Group
Hide Arm/Group Description:

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.

Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Overall Number of Participants Analyzed 102 73
Least Squares Mean (Standard Error)
Unit of Measure: Micrometer
<5 years Number Analyzed 16 participants 21 participants
-8.67  (11.51) -5.99  (10.27)
5 to <18 years Number Analyzed 70 participants 33 participants
5.30  (2.75) 6.17  (4.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Latanoprost Group, Non Prostaglandin Group
Comments <5 years
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8643
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -2.68
Confidence Interval (2-Sided) 95%
-34.30 to 28.94
Parameter Dispersion
Type: Standard Error of the Mean
Value: 15.54
Estimation Comments Change from baseline to last available observation in corneal thickness was analyzed using an ANCOVA model with fixed effect for treatment group with baseline corneal thickness value as covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Latanoprost Group, Non Prostaglandin Group
Comments 5 to <18 years
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8591
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.87
Confidence Interval (2-Sided) 95%
-10.54 to 8.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.87
Estimation Comments Change from baseline to last available observation in corneal thickness was analyzed using an ANCOVA model with fixed effect for treatment group with baseline corneal thickness value as covariate.
12.Secondary Outcome
Title Conjunctival/Ocular Hyperemia
Hide Description

Conjunctiva hyperemia was assessed by slit-lamp examination. When slit-lamp examination is not possible due to subject cooperation, a fixation light and 20-diopter lens (for magnification) was used to assess this parameter. Conjunctival hyperemia was assessed and graded by ophthalmologist at baseline and follow-up visits from grades 0-3 and is as follows:

0 = None, Normal: few vessels of palpebral or bulbar conjunctiva easily observed

  1. = Mild, Reddening of the palpebral or bulbar conjunctiva
  2. = Moderate, Bright reddening of the palpebral or bulbar conjunctiva
  3. = Severe, Deep, bright, and diffuse reddening of the palpebral or bulbar conjunctiva
Time Frame Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis population included all enrolled subjects.
Arm/Group Title Latanoprost Group Non Prostaglandin Group
Hide Arm/Group Description:

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.

Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Overall Number of Participants Analyzed 102 73
Measure Type: Number
Unit of Measure: Participants
6 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Latanoprost Group, Non Prostaglandin Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2413
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 4.5
Confidence Interval (2-Sided) 95%
-10.49 to 19.36
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Number of Participants With a Change in Anterior Segment Biomicroscopy
Hide Description Slit-lamp biomicroscopy (mounted or hand-held) without fluorescein and without dilation of the pupil was performed. When slit-lamp examination was not possible, a fixation light and 20-diopter lens (for magnification) was used. At each scheduled visit, deposition of pigment on the corneal endothelial layer or the lens capsule or any abnormalities of the lids, conjunctivae, cornea, anterior chamber, iris, or lens was examined.
Time Frame Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis population included all enrolled subjects.
Arm/Group Title Latanoprost Group Non Prostaglandin Group
Hide Arm/Group Description:

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.

Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Overall Number of Participants Analyzed 102 73
Measure Type: Number
Unit of Measure: Participants
0 0
14.Secondary Outcome
Title Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline
Hide Description

Fundoscopy was performed after dilation of the pupils (eg, 1 % tropicamide or cyclopentolate and 2 ½ % phenylephrine, or a clinically- appropriate dose according to the clinician’s standard care of each particular patient). The examination included an evaluation of the vitreous body, retina (including the macula), and optic nerve head.

The fundoscopy e-CRF was completed only at baseline because the investigators were required to perform slit lamp, direct or indirect ophthalmoscopy at each visit and report any AEs observed which included the vitreous, retina and optic nerve.

Time Frame Evaluated at Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis population included all enrolled subjects.
Arm/Group Title Latanoprost Group Non Prostaglandin Group
Hide Arm/Group Description:

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.

Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Overall Number of Participants Analyzed 102 73
Measure Type: Number
Unit of Measure: Participants
Vitreous body 3 1
Optic nerve head 43 29
Retina macula choroid 12 1
Time Frame Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
Adverse Event Reporting Description One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
 
Arm/Group Title Latanoprost Group Non Prostaglandin Group
Hide Arm/Group Description

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.

Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.

Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.

All-Cause Mortality
Latanoprost Group Non Prostaglandin Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Latanoprost Group Non Prostaglandin Group
Affected / at Risk (%) Affected / at Risk (%)
Total   11/102 (10.78%)   2/72 (2.78%) 
Congenital, familial and genetic disorders     
Developmental glaucoma  1  1/102 (0.98%)  0/72 (0.00%) 
Neurofibromatosis  1  1/102 (0.98%)  0/72 (0.00%) 
Eye disorders     
Glaucoma  1  2/102 (1.96%)  0/72 (0.00%) 
Iris incarceration  1  1/102 (0.98%)  0/72 (0.00%) 
Posterior capsule opacification  1  0/102 (0.00%)  1/72 (1.39%) 
Retinal detachment  1  1/102 (0.98%)  0/72 (0.00%) 
Infections and infestations     
Pilonidal cyst  1  1/102 (0.98%)  0/72 (0.00%) 
Investigations     
Intraocular pressure increased  1  3/102 (2.94%)  1/72 (1.39%) 
Optic nerve cup/disc ratio increased  1  1/102 (0.98%)  0/72 (0.00%) 
Metabolism and nutrition disorders     
Hyperkalaemia  1  0/102 (0.00%)  1/72 (1.39%) 
Nervous system disorders     
Epilepsy  1  1/102 (0.98%)  1/72 (1.39%) 
Seizure  1  1/102 (0.98%)  0/72 (0.00%) 
Surgical and medical procedures     
Eye operation  1  0/102 (0.00%)  1/72 (1.39%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Latanoprost Group Non Prostaglandin Group
Affected / at Risk (%) Affected / at Risk (%)
Total   20/102 (19.61%)   14/72 (19.44%) 
Eye disorders     
Conjunctival hyperaemia  1  5/102 (4.90%)  1/72 (1.39%) 
Eye pain  1  4/102 (3.92%)  0/72 (0.00%) 
Iris hyperpigmentation  1  4/102 (3.92%)  2/72 (2.78%) 
Infections and infestations     
Nasopharyngitis  1  4/102 (3.92%)  4/72 (5.56%) 
Investigations     
Intraocular pressure increased  1  9/102 (8.82%)  9/72 (12.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 19.0
Inherent limitations of an observational study design (eg, lack of randomization), this was subject to the design/data-related limitations mainly Visual acuity, IOP, and visual field assessments in <5 years old age group were less reliable
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer Clinical Trials.gov Call Center
Organization: Pfizer, Inc
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01265719     History of Changes
Other Study ID Numbers: A6111143
PFI-LAT-2009-01 ( Other Identifier: Alias Study Number )
LYNX ( Other Identifier: Other identifier )
First Submitted: December 16, 2010
First Posted: December 23, 2010
Results First Submitted: February 21, 2017
Results First Posted: November 5, 2018
Last Update Posted: November 5, 2018