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Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects

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ClinicalTrials.gov Identifier: NCT01967147
Recruitment Status : Completed
First Posted : October 22, 2013
Results First Posted : March 23, 2016
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dry Eye
Interventions Drug: Propylene Glycol, 0.6% eye drops
Drug: Preservative-free 0.9% Saline solution
Enrollment 279
Recruitment Details Subjects were recruited from 14 study centers located in France, 4 study centers located in Germany, 3 study centers located in Spain, 3 study centers located in the Netherlands, 4 study centers located in the UK, 4 study centers located in Italy, and 3 study centers located in Poland.
Pre-assignment Details Of the 279 subjects enrolled, 40 were exited as screen failures prior to randomization. An additional 25 were discontinued prior to randomization, following the outcome of the interim analysis. This reporting group includes all randomized subjects (214).
Arm/Group Title Systane Balance Saline
Hide Arm/Group Description Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Period Title: Overall Study
Started 112 102
Completed 99 82
Not Completed 13 20
Reason Not Completed
Adverse Event             5             2
Lack of Efficacy             1             4
Lost to Follow-up             1             2
Withdrawal by Subject             2             4
Non-compliance with Study Drug             0             3
Other             4             5
Arm/Group Title Systane Balance Saline Total
Hide Arm/Group Description Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II Total of all reporting groups
Overall Number of Baseline Participants 112 102 214
Hide Baseline Analysis Population Description
This analysis population includes all randomized subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 102 participants 214 participants
59.5  (15.5) 58.4  (14.0) 59.0  (14.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 102 participants 214 participants
Female
91
  81.3%
72
  70.6%
163
  76.2%
Male
21
  18.8%
30
  29.4%
51
  23.8%
Tear Film Break-up Time (TFBUT)  
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 112 participants 102 participants 214 participants
3.73  (1.37) 3.71  (1.59) 3.72  (1.48)
Total Ocular Surface Staining (TOSS) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 112 participants 102 participants 214 participants
3.45  (2.14) 3.35  (2.38) 3.40  (2.25)
[1]
Measure Description: The TOSS score (a cumulative cornea and conjunctival staining score) was assessed by the investigator using ophthalmic dye and a biomicroscope. Three areas of the ocular surface were graded for dryness on a 0-5 scale (0=Absent, 5=Severe), with a resultant overall score of 0-15.
Ocular surface disease index (OSDI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 112 participants 102 participants 214 participants
40.24  (17.48) 38.27  (17.39) 39.30  (17.42)
[1]
Measure Description: The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability).
Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 112 participants 102 participants 214 participants
44.63  (27.32) 46.15  (27.86) 45.35  (27.52)
[1]
Measure Description: The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment effectiveness questions (Questions 2-5) using a 0-4 Likert-type scale, where 0=None of the time and 4=All of the time. The IDEEL treatment effectiveness score was calculated as the sum of the responses from Questions 2-5 divided by the number of questions (2-5) answered, multiplied by 25, for a resultant overall score of 0-100.
IDEEL Treatment Inconvenience   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 112 participants 102 participants 214 participants
76.61  (22.08) 74.48  (24.85) 75.60  (23.40)
[1]
Measure Description: The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment inconvenience questions (Questions 6, 8-10) using a 0-4 Likert-type scale, where 0=All of the time and 4=None of the time. The IDEEL treatment inconvenience score was calculated as the sum of the responses from Questions 6, 8-10 divided by the number of questions (6, 8-10) answered, multiplied by 25, for a resultant overall score of 0-100.
1.Primary Outcome
Title Change From Baseline in TFBUT at Day 35
Hide Description TFBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using ophthalmic dye and a biomicroscope and measured in seconds. Subjects were dosed in the office 1 hour ±10 minutes prior to TFBUT assessment. A shorter TFBUT indicates a higher likelihood of dry eye symptoms. A positive change indicates an improvement in TFBUT. One eye (study eye) contributed to the analysis.
Time Frame Baseline (Day 0), Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all randomized subjects.
Arm/Group Title Systane Balance Saline
Hide Arm/Group Description:
Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Overall Number of Participants Analyzed 112 102
Mean (Standard Error)
Unit of Measure: seconds
1.5  (0.2) 0.5  (0.2)
2.Secondary Outcome
Title Change From Baseline in TOSS Score at Day 35
Hide Description The TOSS score (a cumulative cornea and conjunctival staining score) was assessed by the investigator using ophthalmic dye and a biomicroscope. Three areas of the ocular surface were graded for dryness on a 0-5 scale (0=Absent, 5=Severe), with a resultant overall score of 0-15. A negative change indicates an improvement in dry eye-related staining. One eye (study eye) contributed to the analysis.
Time Frame Baseline (Day 0), Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all randomized subjects.
Arm/Group Title Systane Balance Saline
Hide Arm/Group Description:
Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Overall Number of Participants Analyzed 112 102
Mean (Standard Error)
Unit of Measure: units on a scale
-0.81  (0.14) -0.64  (0.15)
3.Secondary Outcome
Title Change From Baseline in OSDI Score at Day 35
Hide Description The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative change number represents a perceived improvement in ocular health.
Time Frame Baseline (Day 0), Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all randomized subjects.
Arm/Group Title Systane Balance Saline
Hide Arm/Group Description:
Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Overall Number of Participants Analyzed 112 102
Mean (Standard Error)
Unit of Measure: units on a scale
-13.7  (1.44) -8.38  (1.56)
4.Secondary Outcome
Title Change From Baseline in IDEEL Treatment Effectiveness Score at Day 35
Hide Description The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment effectiveness questions (Questions 2-5) using a 0-4 Likert-type scale, where 0=None of the time and 4=All of the time. The IDEEL treatment effectiveness score was calculated as the sum of the responses from Questions 2-5 divided by the number of questions (2-5) answered, multiplied by 25, for a resultant overall score of 0-100. A positive change number represents perceived improvement.
Time Frame Baseline (Day 0), Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all randomized subjects.
Arm/Group Title Systane Balance Saline
Hide Arm/Group Description:
Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Overall Number of Participants Analyzed 112 102
Mean (Standard Error)
Unit of Measure: units on a scale
21.51  (2.43) 5.50  (2.65)
5.Secondary Outcome
Title Change From Baseline in IDEEL Treatment Inconvenience Score at Day 35
Hide Description The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment inconvenience questions (Questions 6, 8-10) using a 0-4 Likert-type scale, where 0=All of the time and 4=None of the time. The IDEEL treatment inconvenience score was calculated as the sum of the responses from Questions 6, 8-10 divided by the number of questions (6, 8-10) answered, multiplied by 25, for a resultant overall score of 0-100. A positive change number represents perceived improvement.
Time Frame Baseline (Day 0), Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all randomized subjects.
Arm/Group Title Systane Balance Saline
Hide Arm/Group Description:
Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
Overall Number of Participants Analyzed 112 102
Mean (Standard Error)
Unit of Measure: units on a scale
1.30  (1.56) 0.77  (1.70)
Time Frame Adverse events (AEs) were collected for the duration of a subject’s participation in the study (up to 90 days). AEs were reported as pretreatment and treatment-emergent. Ocular adverse events are presented for both study eye and non-study eye.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence, unintended injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the medical device/product. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator, as outlined in the protocol.
 
Arm/Group Title Pretreatment Systane Balance Saline
Hide Arm/Group Description All subjects prior to exposure to investigational product All subjects exposed to Systane® Balance All subjects exposed to Saline
All-Cause Mortality
Pretreatment Systane Balance Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pretreatment Systane Balance Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/279 (0.00%)   2/110 (1.82%)   2/100 (2.00%) 
Injury, poisoning and procedural complications       
Femur fracture  1  0/279 (0.00%)  0/110 (0.00%)  1/100 (1.00%) 
Multiple fractures  1  0/279 (0.00%)  1/110 (0.91%)  0/100 (0.00%) 
Surgical and medical procedures       
Renal cyst excision  1  0/279 (0.00%)  0/110 (0.00%)  1/100 (1.00%) 
Laryngeal operation  1  0/279 (0.00%)  1/110 (0.91%)  0/100 (0.00%) 
Vascular disorders       
Arterial haemorrhage  1  0/279 (0.00%)  0/110 (0.00%)  1/100 (1.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pretreatment Systane Balance Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/279 (0.00%)   6/110 (5.45%)   1/100 (1.00%) 
Eye disorders       
Eye irritation  1  0/279 (0.00%)  6/110 (5.45%)  1/100 (1.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
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.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Name/Title: Global Brand Med Affairs Lead, GCRA, GMA Pharma
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01967147     History of Changes
Other Study ID Numbers: M-13-027
First Submitted: October 18, 2013
First Posted: October 22, 2013
Results First Submitted: January 27, 2016
Results First Posted: March 23, 2016
Last Update Posted: March 23, 2016