Trial Outcomes & Findings for A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ in Subjects With Dry Eye Disease (NCT NCT01664949)
NCT ID: NCT01664949
Last Updated: 2015-09-21
Results Overview
The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). A negative number change from Baseline indicates improvement.
COMPLETED
PHASE3
460 participants
Baseline, Day 90
2015-09-21
Participant Flow
Participant milestones
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
OPTIVE™
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
|---|---|---|
|
Overall Study
STARTED
|
224
|
236
|
|
Overall Study
COMPLETED
|
200
|
211
|
|
Overall Study
NOT COMPLETED
|
24
|
25
|
Reasons for withdrawal
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
OPTIVE™
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
12
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Personal Reasons
|
3
|
4
|
|
Overall Study
Protocol Violation
|
5
|
5
|
|
Overall Study
Other Miscellaneous Reasons
|
3
|
1
|
Baseline Characteristics
A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ in Subjects With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
n=224 Participants
Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
OPTIVE™
n=236 Participants
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
Total
n=460 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 30 years
|
9 participants
13.77 • n=5 Participants
|
10 participants
13.65 • n=7 Participants
|
19 participants
n=5 Participants
|
|
Age, Customized
30 to 40 years
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Age, Customized
> 40 years
|
200 participants
n=5 Participants
|
211 participants
n=7 Participants
|
411 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
182 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
371 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 90Population: Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.
The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). A negative number change from Baseline indicates improvement.
Outcome measures
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
n=196 Participants
Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
OPTIVE™
n=198 Participants
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
|---|---|---|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90
Baseline
|
41.77 score on a scale
Standard Deviation 14.018
|
40.92 score on a scale
Standard Deviation 13.310
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90
Change from Baseline at Day 90 (n=181,185)
|
-16.88 score on a scale
Standard Deviation 17.496
|
-15.97 score on a scale
Standard Deviation 16.146
|
SECONDARY outcome
Timeframe: Baseline, Day 90Population: Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.
TBUT is the time in seconds for the tear film to visually break up after a complete blink. The average of 3 consecutive observations is reported for each participant. The longer it takes, the more stable the tear film. The eye with the shorter average TBUT at Baseline was used for analysis. A positive number change from Baseline indicates improvement.
Outcome measures
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
n=196 Participants
Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
OPTIVE™
n=198 Participants
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
|---|---|---|
|
Change From Baseline in Tear Break-up Time (TBUT)
Baseline
|
4.50 seconds
Standard Deviation 1.868
|
4.44 seconds
Standard Deviation 1.894
|
|
Change From Baseline in Tear Break-up Time (TBUT)
Change from Baseline at Day 90 (n=181,185)
|
2.69 seconds
Standard Deviation 5.167
|
2.24 seconds
Standard Deviation 3.262
|
SECONDARY outcome
Timeframe: Baseline, Day 90Population: Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.
Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.
Outcome measures
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
n=196 Participants
Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
OPTIVE™
n=198 Participants
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
|---|---|---|
|
Change From Baseline in Corneal Staining
Change from Baseline at Day 90 (n= 182, 184)
|
-0.7 score on a scale
Standard Deviation 0.88
|
-0.9 score on a scale
Standard Deviation 0.91
|
|
Change From Baseline in Corneal Staining
Baseline
|
1.5 score on a scale
Standard Deviation 0.99
|
1.6 score on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Baseline, Day 90Population: Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.
Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). Conjunctival staining has 2 zones, nasal and temporal, which are added together to provide the total staining score. The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.
Outcome measures
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
n=196 Participants
Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
OPTIVE™
n=198 Participants
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
|---|---|---|
|
Change From Baseline in Conjunctival Staining
Baseline
|
2.8 score on a scale
Standard Deviation 1.70
|
3.0 score on a scale
Standard Deviation 1.79
|
|
Change From Baseline in Conjunctival Staining
Change from Baseline at Day 90 (n= 181, 185)
|
-1.3 score on a scale
Standard Deviation 1.57
|
-1.4 score on a scale
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: Baseline, Day 90Population: Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.
The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement.
Outcome measures
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
n=196 Participants
Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
OPTIVE™
n=198 Participants
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
|---|---|---|
|
Change From Baseline in the Schirmer Test
Baseline
|
9.29 mm/5 minutes
Standard Deviation 6.692
|
8.10 mm/5 minutes
Standard Deviation 5.888
|
|
Change From Baseline in the Schirmer Test
Change from Baseline at Day 90 (n=172,174)
|
1.38 mm/5 minutes
Standard Deviation 6.933
|
1.53 mm/5 minutes
Standard Deviation 6.253
|
Adverse Events
Carboxymethylcellulose Based Eye Drop Formulation A
OPTIVE™
Serious adverse events
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
n=224 participants at risk
Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
OPTIVE™
n=236 participants at risk
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.45%
1/224
|
0.00%
0/236
|
|
Infections and infestations
Pyelonephritis acute
|
0.45%
1/224
|
0.00%
0/236
|
|
Cardiac disorders
Cardiac failure
|
0.45%
1/224
|
0.00%
0/236
|
|
Cardiac disorders
Myocardial infarction
|
0.45%
1/224
|
0.00%
0/236
|
|
Psychiatric disorders
Anxiety disorder
|
0.45%
1/224
|
0.00%
0/236
|
|
Nervous system disorders
Carotid artery stenosis
|
0.45%
1/224
|
0.00%
0/236
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.45%
1/224
|
0.00%
0/236
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/224
|
2.1%
1/47
|
|
Infections and infestations
Appendicitis
|
0.00%
0/224
|
0.42%
1/236
|
|
Congenital, familial and genetic disorders
Vitello-intestinal duct remnant
|
0.00%
0/224
|
0.42%
1/236
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.00%
0/224
|
0.42%
1/236
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/224
|
0.42%
1/236
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/224
|
0.42%
1/236
|
Other adverse events
| Measure |
Carboxymethylcellulose Based Eye Drop Formulation A
n=224 participants at risk
Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
OPTIVE™
n=236 participants at risk
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
|
|---|---|---|
|
Eye disorders
Eye irritation
|
6.7%
15/224
|
2.5%
6/236
|
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