Trial Outcomes & Findings for Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED) (NCT NCT03785340)

Last Updated: 2022-07-18

Results Overview

The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

252 participants

Primary outcome timeframe

Baseline, 4 weeks (Day 28)

Results posted on

2022-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	OCU-310 Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks	Placebo Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks
Overall Study STARTED	126	126
Overall Study Received at Least 1 Study Treatment	126	126
Overall Study COMPLETED	123	126
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	OCU-310 Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks	Placebo Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks
Overall Study Lost to Follow-up	2	0
Overall Study Adverse Event	1	0

Baseline Characteristics

Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OCU-310 n=126 Participants Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks	Placebo n=126 Participants Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks	Total n=252 Participants Total of all reporting groups
Age, Continuous	61.7 years n=5 Participants	62.1 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Sex · Female	106 Participants n=5 Participants	105 Participants n=7 Participants	211 Participants n=5 Participants
Sex: Female, Male Sex · Male	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	114 Participants n=5 Participants	115 Participants n=7 Participants	229 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 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
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	11 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) White	101 Participants n=5 Participants	111 Participants n=7 Participants	212 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4 weeks (Day 28)

Population: The Intention-to-treat (ITT) set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. Here, the overall number of participants analyzed is the number of participants with evaluable data at each time point.

Outcome measures

Outcome measures
Measure	OCU-310 n=124 Participants Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks	Placebo n=124 Participants Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks
Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score Baseline	73.0 Score on a scale Standard Deviation 13.6	72.7 Score on a scale Standard Deviation 12.4
Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score 4 weeks (Day 28)	56.6 Score on a scale Standard Deviation 23.2	57.2 Score on a scale Standard Deviation 19.8
Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score Change from Baseline at 4 weeks (Day 28)	-16.4 Score on a scale Standard Deviation 20.9	-15.5 Score on a scale Standard Deviation 19.9

PRIMARY outcome

Timeframe: Baseline, 4 Weeks (Day 28)

Population: The ITT set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. Here, the overall number of participants analyzed is the number of participants with evaluable data at each time point.

Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.

Outcome measures

Outcome measures
Measure	OCU-310 n=124 Participants Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks	Placebo n=124 Participants Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks
Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores Baseline	4.2 score on a scale Standard Deviation 1.1	4.1 score on a scale Standard Deviation 1.0
Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores 4 Weeks (Day 28)	3.6 score on a scale Standard Deviation 1.6	3.2 score on a scale Standard Deviation 1.3
Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores Change from Baseline at 4 Weeks (Day 28)	-0.6 score on a scale Standard Deviation 1.4	-0.9 score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline, 2 weeks (Day 14)

Population: The ITT set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. 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.

Outcome measures

Outcome measures
Measure	OCU-310 n=124 Participants Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks	Placebo n=124 Participants Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks
Change From Baseline to 2 Weeks (Day 14) in SANDE Score Baseline	73.0 score on a scale Standard Deviation 13.6	72.7 score on a scale Standard Deviation 12.4
Change From Baseline to 2 Weeks (Day 14) in SANDE Score 2 weeks (Day 14)	61.3 score on a scale Standard Deviation 20.5	58.6 score on a scale Standard Deviation 17.5
Change From Baseline to 2 Weeks (Day 14) in SANDE Score Change from Baseline at 2 weeks (Day 14)	-11.6 score on a scale Standard Deviation 18.3	-14.1 score on a scale Standard Deviation 16.3

SECONDARY outcome

Timeframe: Baseline, 2 Weeks (Day 14)

Population: The ITT set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. 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.

Outcome measures

Outcome measures
Measure	OCU-310 n=124 Participants Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks	Placebo n=124 Participants Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks
Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores Baseline	4.2 score on a scale Standard Deviation 1.1	4.1 score on a scale Standard Deviation 1.0
Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores 2 Weeks (Day 14)	3.8 score on a scale Standard Deviation 1.4	3.4 score on a scale Standard Deviation 1.3
Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores Change from Baseline at 2 Weeks (Day 14)	-0.4 score on a scale Standard Deviation 1.2	-0.7 score on a scale Standard Deviation 1.0

Adverse Events

OCU-310

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

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