Trial Outcomes & Findings for Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease (NCT NCT01459588)
NCT ID: NCT01459588
Last Updated: 2019-04-16
Results Overview
The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement.
COMPLETED
PHASE3
315 participants
Baseline, Day 30
2019-04-16
Participant Flow
Participant milestones
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
|
Carboxymethylcellulose Based Eye Drop Formulation B
Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Carboxymethylcellulose Preservative-Free Lubricant Eye Drops
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Carboxymethylcellulose Based Lubricant Eye Drops
Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
105
|
51
|
103
|
56
|
|
Overall Study
COMPLETED
|
104
|
49
|
102
|
55
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
n=105 Participants
Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
|
Carboxymethylcellulose Based Eye Drop Formulation B
n=51 Participants
Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Carboxymethylcellulose Preservative-Free Lubricant Eye Drops
n=103 Participants
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Carboxymethylcellulose Based Lubricant Eye Drops
n=56 Participants
Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
|
Total
n=315 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<30 years
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Age, Customized
30 to 40 years
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Age, Customized
>40 years
|
86 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
262 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
255 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-treat population included all randomized participants.
The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
n=105 Participants
Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
|
Carboxymethylcellulose Based Eye Drop Formulation B
n=51 Participants
Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Carboxymethylcellulose Preservative-Free Lubricant Eye Drops
n=103 Participants
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Carboxymethylcellulose Based Lubricant Eye Drops
n=56 Participants
Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
|
|---|---|---|---|---|
|
Change From Baseline in Ocular Surface Disease Index© Questionnaire Score
Baseline
|
41.48 Score on a scale
Standard Deviation 14.797
|
38.27 Score on a scale
Standard Deviation 12.825
|
40.28 Score on a scale
Standard Deviation 13.509
|
40.18 Score on a scale
Standard Deviation 13.443
|
|
Change From Baseline in Ocular Surface Disease Index© Questionnaire Score
Change from baseline at Day 30
|
-15.66 Score on a scale
Standard Deviation 14.717
|
-9.78 Score on a scale
Standard Deviation 17.986
|
-14.59 Score on a scale
Standard Deviation 15.090
|
-13.77 Score on a scale
Standard Deviation 16.112
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-treat population included all randomized participants.
Tear Break-up Time (TBUT) was assessed at Baseline and Day 30. TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The shorter the tear break-up time, the worse the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
n=105 Participants
Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
|
Carboxymethylcellulose Based Eye Drop Formulation B
n=51 Participants
Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Carboxymethylcellulose Preservative-Free Lubricant Eye Drops
n=103 Participants
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Carboxymethylcellulose Based Lubricant Eye Drops
n=56 Participants
Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
|
|---|---|---|---|---|
|
Change From Baseline in Tear Break-up Time
Change from baseline at Day 30
|
1.36 Seconds
Standard Deviation 2.848
|
1.21 Seconds
Standard Deviation 2.521
|
1.33 Seconds
Standard Deviation 2.497
|
1.06 Seconds
Standard Deviation 2.018
|
|
Change From Baseline in Tear Break-up Time
Baseline
|
4.92 Seconds
Standard Deviation 1.790
|
4.61 Seconds
Standard Deviation 1.739
|
4.94 Seconds
Standard Deviation 1.808
|
5.06 Seconds
Standard Deviation 1.699
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-treat population included all randomized participants.
The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0= no staining, 5 = severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in corneal staining (improvement).
Outcome measures
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
n=105 Participants
Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
|
Carboxymethylcellulose Based Eye Drop Formulation B
n=51 Participants
Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Carboxymethylcellulose Preservative-Free Lubricant Eye Drops
n=103 Participants
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Carboxymethylcellulose Based Lubricant Eye Drops
n=56 Participants
Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
|
|---|---|---|---|---|
|
Change From Baseline in Corneal Staining
Change from baseline at Day 30
|
-0.7 Score on a scale
Standard Deviation 2.90
|
0.1 Score on a scale
Standard Deviation 3.17
|
-1.5 Score on a scale
Standard Deviation 2.37
|
-1.4 Score on a scale
Standard Deviation 2.89
|
|
Change From Baseline in Corneal Staining
Baseline
|
4.9 Score on a scale
Standard Deviation 3.84
|
5.0 Score on a scale
Standard Deviation 3.76
|
5.0 Score on a scale
Standard Deviation 3.92
|
4.7 Score on a scale
Standard Deviation 3.24
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-treat population included all randomized participants.
The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).
Outcome measures
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
n=105 Participants
Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
|
Carboxymethylcellulose Based Eye Drop Formulation B
n=51 Participants
Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Carboxymethylcellulose Preservative-Free Lubricant Eye Drops
n=103 Participants
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Carboxymethylcellulose Based Lubricant Eye Drops
n=56 Participants
Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
|
|---|---|---|---|---|
|
Change From Baseline in Conjunctival Staining
Baseline
|
6.7 Score on as scale
Standard Deviation 5.69
|
6.3 Score on as scale
Standard Deviation 4.77
|
6.1 Score on as scale
Standard Deviation 4.41
|
6.7 Score on as scale
Standard Deviation 5.37
|
|
Change From Baseline in Conjunctival Staining
Change from baseline at Day 30
|
-0.6 Score on as scale
Standard Deviation 4.17
|
0.5 Score on as scale
Standard Deviation 3.77
|
-1.2 Score on as scale
Standard Deviation 3.70
|
-0.8 Score on as scale
Standard Deviation 3.70
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intent-to-treat population included all randomized participants.
The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive number change from baseline indicates an increase in tears (improvement).
Outcome measures
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
n=105 Participants
Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
|
Carboxymethylcellulose Based Eye Drop Formulation B
n=51 Participants
Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Carboxymethylcellulose Preservative-Free Lubricant Eye Drops
n=103 Participants
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Carboxymethylcellulose Based Lubricant Eye Drops
n=56 Participants
Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
|
|---|---|---|---|---|
|
Change From Baseline in Schirmer Test Results
Baseline
|
10.3 millimeters
Standard Deviation 7.37
|
8.4 millimeters
Standard Deviation 7.26
|
10.4 millimeters
Standard Deviation 6.79
|
10.1 millimeters
Standard Deviation 7.60
|
|
Change From Baseline in Schirmer Test Results
Change from baseline at Day 30
|
1.8 millimeters
Standard Deviation 6.97
|
2.4 millimeters
Standard Deviation 6.30
|
2.0 millimeters
Standard Deviation 6.27
|
2.6 millimeters
Standard Deviation 6.59
|
Adverse Events
Carboxymethylcellulose Based Eye Drop Formulation A
Carboxymethylcellulose Based Eye Drop Formulation B
Carboxymethylcellulose Preservative-Free Lubricant Eye Drops
Carboxymethylcellulose Based Lubricant Eye Drops
Serious adverse events
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
n=105 participants at risk
Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
|
Carboxymethylcellulose Based Eye Drop Formulation B
n=51 participants at risk
Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Carboxymethylcellulose Preservative-Free Lubricant Eye Drops
n=103 participants at risk
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
|
Carboxymethylcellulose Based Lubricant Eye Drops
n=56 participants at risk
Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Bile duct stone
|
0.95%
1/105
|
0.00%
0/51
|
0.00%
0/103
|
0.00%
0/56
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/105
|
0.00%
0/51
|
0.00%
0/103
|
1.8%
1/56
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER