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Effects of Anti-Glaucoma Medications on the Ocular Surface (BAK)

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ClinicalTrials.gov Identifier: NCT01315574
Recruitment Status : Terminated (Slow Enrollment)
First Posted : March 15, 2011
Results First Posted : February 3, 2017
Last Update Posted : March 16, 2017
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Glaucoma
Interventions Drug: Travoprost
Drug: Latanoprost
Enrollment 14

Recruitment Details Participants recruited from May 2011 to June 2013
Pre-assignment Details  
Arm/Group Title Latanoprost (Xalatan) Travoprost (Travatan Z)
Hide Arm/Group Description

7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.

Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.

7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.

Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.

Period Title: Overall Study
Started 7 7
Completed 7 7
Not Completed 0 0
Arm/Group Title Latanoprost (Xalatan) Travoprost (Travatan Z) Total
Hide Arm/Group Description

7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.

Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.

7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.

Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.

Total of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
* For IOP the baseline sample size for Latanoprost is 6 patients, whereas for all other outcome measures n= 7 patients.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 14 participants
65.3  (7.9) 68.3  (10.0) 66.8  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Female
5
  71.4%
5
  71.4%
10
  71.4%
Male
2
  28.6%
2
  28.6%
4
  28.6%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 7 participants 14 participants
7 7 14
[1]
Measure Description: Participant population: newly diagnosed glaucoma patients.
Central Corneal Dendritic Cell Density  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^2
Number Analyzed 7 participants 7 participants 14 participants
126  (88) 91  (60) 109  (75)
Intraocular Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 7 participants 7 participants 14 participants
21  (6) 22  (4) 21.5  (4.8)
Corneal Fluorescein Staining Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 7 participants 7 participants 14 participants
0.6  (1.1) 1.3  (2.0) 0.9  (1.6)
[1]
Measure Description: Corneal fluorescein staining scores range from 0 to 4 points: 0=non-staining to 4 =regional whole staining of the cornea. Higher scores indicate worse eye condition.
Tear Break-Up Time (TBUT)  
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 7 participants 7 participants 14 participants
7.9  (2.0) 8.4  (3.7) 8.1  (2.9)
1.Primary Outcome
Title Effectiveness in Lowering Intraocular Pressure
Hide Description Applanation tonometry will be used to measure patients' intraocular pressure
Time Frame At the 6 month follow-up time point
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects in each arm/group did not complete 6-month follow up visit. Data was not collected and analysis not completed.
Arm/Group Title Latanoprost (Xalatan) Travoprost (Travatan Z)
Hide Arm/Group Description:

7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.

Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.

7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.

Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.

Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: mmHg
13.7  (2.8) 17.2  (2.7)
2.Secondary Outcome
Title Corneal Fluorescein Staining Score
Hide Description Corneal Fluorescein Staining score was used in this study to quantify changes in dry eye symptoms. Corneal fluorescein staining scores range from 0 to 4 points: 0=non-staining to 4 =regional whole staining of the cornea. Higher scores indicate worse eye condition.
Time Frame At the 6 month follow-up time point
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects in each arm/group did not complete 6-month follow up visit. Data was not collected and analysis not completed.
Arm/Group Title Latanoprost (Xalatan) Travoprost (Travatan Z)
Hide Arm/Group Description:

7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.

Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.

7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.

Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.

Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: units on a scale (1-4)
1  (1.7) 1.5  (2.2)
3.Secondary Outcome
Title Tear Film Break-Up Time
Hide Description Tear Film Break-Up Time (TBUT) is a clinical test used to quantify changes in dry eye symptoms. The Tear Film Break-Up time is the number of seconds between the subjects last blink and the detection of the first dry spot in the tear film.
Time Frame At the 6 month follow-up time point
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects in each arm/group did not complete 6-month follow up visit. Data was not collected and analysis not completed.
Arm/Group Title Latanoprost (Xalatan) Travoprost (Travatan Z)
Hide Arm/Group Description:

7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.

Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.

7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.

Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.

Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: Seconds
6.3  (1.7) 6.7  (3.9)
Time Frame Over the course of the 6 month study period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Latanoprost (Xalatan) Travoprost (Travatan Z)
Hide Arm/Group Description

7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.

Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.

7 Patients were be randomized to receive BAK-free Travatan Z for treatment of their glaucoma.

Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.

All-Cause Mortality
Latanoprost (Xalatan) Travoprost (Travatan Z)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Latanoprost (Xalatan) Travoprost (Travatan Z)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Latanoprost (Xalatan) Travoprost (Travatan Z)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Early termination due to very slow rate of recruitment, hence reduced power of the study (small sample size); some patients lost to follow-up.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Dr. Pedram Hamrah
Organization: Massachusetts Eye and Ear Infirmary
Phone: 617-573-6060
Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01315574     History of Changes
Other Study ID Numbers: 11-007H
First Submitted: March 10, 2011
First Posted: March 15, 2011
Results First Submitted: August 15, 2016
Results First Posted: February 3, 2017
Last Update Posted: March 16, 2017