Trial Outcomes & Findings for "Efficacy and Safety of Brimonidine Tartrate Preservative-Free Formulation in Adults With Ocular Redness" (NCT NCT05360784)
NCT ID: NCT05360784
Last Updated: 2024-08-26
Results Overview
Ocular redness score evaluated by the investigator from 5 minutes to 240 minutes after investigational drug instillation (0-4 unit scale, where 0 = None and 4 = Extremely severe).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
380 participants
Primary outcome timeframe
Assessed at 5, 15, 30, 60, 90,120,180, 240 minutes post instillation.
Results posted on
2024-08-26
Participant Flow
Participant milestones
| Measure |
Brimonidine Tartrate Preservation-free
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation: Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation. Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
|
Lumify®
Lumify® (brimonidine tartrate ophthalmic solution 0.025%)
Lumify® (brimonidine tartrate ophthalmic solution 0.025%): Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
190
|
190
|
|
Overall Study
COMPLETED
|
165
|
179
|
|
Overall Study
NOT COMPLETED
|
25
|
11
|
Reasons for withdrawal
| Measure |
Brimonidine Tartrate Preservation-free
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation: Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation. Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
|
Lumify®
Lumify® (brimonidine tartrate ophthalmic solution 0.025%)
Lumify® (brimonidine tartrate ophthalmic solution 0.025%): Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
|
|---|---|---|
|
Overall Study
Discontinued
|
25
|
11
|
Baseline Characteristics
"Efficacy and Safety of Brimonidine Tartrate Preservative-Free Formulation in Adults With Ocular Redness"
Baseline characteristics by cohort
| Measure |
Brimonidine Tartrate Preservation-free
n=190 Participants
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation: Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation. Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
|
Lumify®
n=190 Participants
Lumify® (brimonidine tartrate ophthalmic solution 0.025%)
Lumify® (brimonidine tartrate ophthalmic solution 0.025%): Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
|
Total
n=380 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
114 Participants
n=99 Participants
|
106 Participants
n=107 Participants
|
220 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
76 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 14.65 • n=99 Participants
|
59.5 years
STANDARD_DEVIATION 14.76 • n=107 Participants
|
59 years
STANDARD_DEVIATION 14.70 • n=206 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
267 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
178 Participants
n=99 Participants
|
173 Participants
n=107 Participants
|
351 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
46 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
138 Participants
n=99 Participants
|
138 Participants
n=107 Participants
|
276 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
190 Participants
n=99 Participants
|
190 Participants
n=107 Participants
|
380 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Assessed at 5, 15, 30, 60, 90,120,180, 240 minutes post instillation.Ocular redness score evaluated by the investigator from 5 minutes to 240 minutes after investigational drug instillation (0-4 unit scale, where 0 = None and 4 = Extremely severe).
Outcome measures
| Measure |
Brimonidine Tartrate Preservation-free
n=190 Participants
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation: Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation. Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
|
Lumify®
n=190 Participants
Lumify® (brimonidine tartrate ophthalmic solution 0.025%)
Lumify® (brimonidine tartrate ophthalmic solution 0.025%): Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
|
|---|---|---|
|
Ocular Redness
60 minutes Post Instillation
|
0.47 score on a scale
Standard Error 0.040
|
0.52 score on a scale
Standard Error 0.041
|
|
Ocular Redness
15 minutes Post Instillation
|
0.40 score on a scale
Standard Error 0.038
|
0.49 score on a scale
Standard Error 0.041
|
|
Ocular Redness
30 minutes Post Instillation
|
0.42 score on a scale
Standard Error 0.038
|
0.50 score on a scale
Standard Error 0.041
|
|
Ocular Redness
90 minutes Post Instillation
|
0.54 score on a scale
Standard Error 0.043
|
0.58 score on a scale
Standard Error 0.044
|
|
Ocular Redness
120 minutes Post Instillation
|
0.64 score on a scale
Standard Error 0.046
|
0.67 score on a scale
Standard Error 0.046
|
|
Ocular Redness
180 minutes Post Instillation
|
0.79 score on a scale
Standard Error 0.046
|
0.84 score on a scale
Standard Error 0.049
|
|
Ocular Redness
240 minutes Post Instillation
|
0.99 score on a scale
Standard Error 0.047
|
0.98 score on a scale
Standard Error 0.049
|
|
Ocular Redness
5 minutes Post Instillation
|
0.46 score on a scale
Standard Error 0.039
|
0.53 score on a scale
Standard Error 0.041
|
Adverse Events
Brimonidine Tartrate Preservation-free
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Lumify®
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brimonidine Tartrate Preservation-free
n=188 participants at risk
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation: Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation. Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
|
Lumify®
n=190 participants at risk
Lumify® (brimonidine tartrate ophthalmic solution 0.025%)
Lumify® (brimonidine tartrate ophthalmic solution 0.025%): Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
|
|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/188 • Through study completion, an average of 36 days.
|
0.53%
1/190 • Through study completion, an average of 36 days.
|
Other adverse events
| Measure |
Brimonidine Tartrate Preservation-free
n=188 participants at risk
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation: Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation. Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
|
Lumify®
n=190 participants at risk
Lumify® (brimonidine tartrate ophthalmic solution 0.025%)
Lumify® (brimonidine tartrate ophthalmic solution 0.025%): Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.
|
|---|---|---|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/188 • Through study completion, an average of 36 days.
|
2.1%
4/190 • Through study completion, an average of 36 days.
|
|
Infections and infestations
Covid 19
|
2.7%
5/188 • Through study completion, an average of 36 days.
|
1.1%
2/190 • Through study completion, an average of 36 days.
|
|
Infections and infestations
Sinusitis
|
1.1%
2/188 • Through study completion, an average of 36 days.
|
3.2%
6/190 • Through study completion, an average of 36 days.
|
|
General disorders
Instillation site pain
|
3.2%
6/188 • Through study completion, an average of 36 days.
|
3.2%
6/190 • Through study completion, an average of 36 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact Sponsor directly for details
- Publication restrictions are in place
Restriction type: OTHER