Trial Outcomes & Findings for Dry Eye Disease Study With Brimonidine (NCT NCT03418727)
NCT ID: NCT03418727
Last Updated: 2022-07-06
Results Overview
Participants assessed their tolerance to the administration of the study drug, utilizing a VAS. The VAS is a 100-mm horizontal line with verbal descriptors at either end. Participants placed a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
Days 1, 28, 56, and 84
Results posted on
2022-07-06
Participant Flow
Participant milestones
| Measure |
Brimonidine and Corticosteroid Combination Therapy
Brimonidine (0.2%) administered as eye drops, followed by loteprednol ophthalmic suspension (0.2%), two times a day (BID) for 12 weeks
|
Brimonidine Monotherapy
Brimonidine (0.2%) administered as eye drops followed by placebo BID for 12 weeks
|
Placebo
Sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application BID for 12 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
27
|
|
Overall Study
Received at Least 1 Study Treatment
|
29
|
28
|
27
|
|
Overall Study
COMPLETED
|
28
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
Brimonidine and Corticosteroid Combination Therapy
Brimonidine (0.2%) administered as eye drops, followed by loteprednol ophthalmic suspension (0.2%), two times a day (BID) for 12 weeks
|
Brimonidine Monotherapy
Brimonidine (0.2%) administered as eye drops followed by placebo BID for 12 weeks
|
Placebo
Sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application BID for 12 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
Baseline Characteristics
Dry Eye Disease Study With Brimonidine
Baseline characteristics by cohort
| Measure |
Brimonidine and Corticosteroid Combination Therapy
n=29 Participants
Brimonidine (0.2%) administered as eye drops, followed by loteprednol ophthalmic suspension (0.2%) BID for 12 weeks
|
Brimonidine Monotherapy
n=28 Participants
Brimonidine (0.2%) administered as eye drops followed by placebo BID for 12 weeks
|
Placebo
n=27 Participants
Sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application BID for 12 weeks
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 11.41 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 13.88 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 14.23 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 13.09 • n=4 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Days 1, 28, 56, and 84Population: Safety population that included all randomized participants who received at least one dose of study medication. Here, the overall number of participants analyzed are those evaluable for this Outcome Measure and the Number Analyzed per Row is the number of participants with evaluable data at each time point.
Participants assessed their tolerance to the administration of the study drug, utilizing a VAS. The VAS is a 100-mm horizontal line with verbal descriptors at either end. Participants placed a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).
Outcome measures
| Measure |
Brimonidine and Corticosteroid Combination Therapy
n=29 Participants
Brimonidine (0.2%) administered as eye drops, followed by loteprednol ophthalmic suspension (0.2%) BID for 12 weeks
|
Brimonidine Monotherapy
n=28 Participants
Brimonidine (0.2%) administered as eye drops followed by placebo BID for 12 weeks
|
Placebo
n=27 Participants
Sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application BID for 12 weeks
|
|---|---|---|---|
|
Tolerance of Test Substance Visual Analogue Scale (VAS) Score
Day 1
|
82.1 score on a scale
Interval 74.5 to 89.8
|
87.0 score on a scale
Interval 82.2 to 91.9
|
95.0 score on a scale
Interval 92.3 to 97.7
|
|
Tolerance of Test Substance Visual Analogue Scale (VAS) Score
Day 28
|
91.1 score on a scale
Interval 86.6 to 95.5
|
87.4 score on a scale
Interval 82.5 to 92.3
|
88.2 score on a scale
Interval 82.7 to 93.7
|
|
Tolerance of Test Substance Visual Analogue Scale (VAS) Score
Day 56
|
92.0 score on a scale
Interval 88.3 to 95.8
|
85.6 score on a scale
Interval 80.6 to 90.7
|
91.0 score on a scale
Interval 84.2 to 97.9
|
|
Tolerance of Test Substance Visual Analogue Scale (VAS) Score
Day 84
|
87.8 score on a scale
Interval 82.2 to 93.5
|
85.9 score on a scale
Interval 78.6 to 93.1
|
94.8 score on a scale
Interval 91.6 to 98.1
|
Adverse Events
Brimonidine and Corticosteroid Combination Therapy
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Brimonidine Monotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brimonidine and Corticosteroid Combination Therapy
n=29 participants at risk
Brimonidine (0.2%) administered as eye drops, followed by loteprednol ophthalmic suspension (0.2%) BID for 12 weeks
|
Brimonidine Monotherapy
n=28 participants at risk
Brimonidine (0.2%) administered as eye drops followed by placebo BID for 12 weeks
|
Placebo
n=27 participants at risk
Sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application BID for 12 weeks
|
|---|---|---|---|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
3.4%
1/29 • Day 1 (post-dose) up to 105 Days
|
0.00%
0/28 • Day 1 (post-dose) up to 105 Days
|
0.00%
0/27 • Day 1 (post-dose) up to 105 Days
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/29 • Day 1 (post-dose) up to 105 Days
|
0.00%
0/28 • Day 1 (post-dose) up to 105 Days
|
3.7%
1/27 • Day 1 (post-dose) up to 105 Days
|
Other adverse events
Adverse event data not reported
Additional Information
Vijay Tammara, VP, Strategic Regulatory Operations
Ocugen
Phone: 484-328-4751
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place