Trial Outcomes & Findings for Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis (NCT NCT05579730)
NCT ID: NCT05579730
Last Updated: 2025-02-14
Results Overview
Ocular itching score (measured on a 0-4 unit scale, allowing half-unit increments; average score of the subject's two eyes) assessed by the subjects at 3 (±1), 5 (±1), and 7 (±1) minutes post-CAC.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
188 participants
Primary outcome timeframe
Assessed at Visit 4b on day 1 (duration of action CAC at 8 hours post-instillation of study medication) and Visit 5 on day 15 (onset of action CAC at 15 minutes post-instillation of study medication).
Results posted on
2025-02-14
Participant Flow
Participant milestones
| Measure |
Combination
Brimonidine tartrate 0.025% / ketotifen fumarate 0.035% combination ophthalmic solution administered bilaterally.
|
Ketotifen Fumarate
Ketotifen fumarate ophthalmic solution 0.035% administered bilaterally
|
Brimonidine Tartrate
Brimonidine tartrate ophthalmic solution 0.025% administered bilaterally
|
Vehicle
Vehicle ophthalmic solution administered bilaterally
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
47
|
46
|
|
Overall Study
COMPLETED
|
45
|
45
|
47
|
44
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis
Baseline characteristics by cohort
| Measure |
Combination
n=47 Participants
Brimonidine tartrate 0.025% / ketotifen fumarate 0.035% ophthalmic solution administered bilaterally
|
Ketotifen Fumarate
n=48 Participants
Ketotifen fumarate ophthalmic solution 0.035% administered bilaterally
|
Brimonidine Tartrate
n=47 Participants
Brimonidine tartrate ophthalmic solution 0.025% administered bilaterally
|
Vehicle
n=46 Participants
Vehicle ophthalmic solution administered bilaterally
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 16.90 • n=5 Participants
|
49.3 years
STANDARD_DEVIATION 14.19 • n=7 Participants
|
45.9 years
STANDARD_DEVIATION 17.74 • n=5 Participants
|
49.9 years
STANDARD_DEVIATION 12.18 • n=4 Participants
|
48.1 years
STANDARD_DEVIATION 15.38 • n=21 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
122 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
170 Participants
n=21 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
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Assessed at Visit 4b on day 1 (duration of action CAC at 8 hours post-instillation of study medication) and Visit 5 on day 15 (onset of action CAC at 15 minutes post-instillation of study medication).Ocular itching score (measured on a 0-4 unit scale, allowing half-unit increments; average score of the subject's two eyes) assessed by the subjects at 3 (±1), 5 (±1), and 7 (±1) minutes post-CAC.
Outcome measures
| Measure |
Combination
n=47 Participants
Brimonidine tartrate 0.025% / ketotifen fumarate 0.035% combination ophthalmic solution administered bilaterally
|
Ketotifen Fumarate
n=48 Participants
Ketotifen fumarate ophthalmic solution 0.035% administered bilaterally
|
Brimonidine Tartrate
n=47 Participants
Brimonidine tartrate ophthalmic solution 0.025% administered bilaterally
|
Vehicle
n=46 Participants
Vehicle ophthalmic solution administered bilaterally
|
|---|---|---|---|---|
|
Ocular Itching
Visit 4b, 3 min Post-CAC
|
1.176 score on a scale
Standard Error 0.1464
|
1.708 score on a scale
Standard Error 0.1487
|
2.426 score on a scale
Standard Error 0.1330
|
2.362 score on a scale
Standard Error 0.1512
|
|
Ocular Itching
Visit 4b, 5 min Post-CAC
|
1.287 score on a scale
Standard Error 0.1507
|
1.688 score on a scale
Standard Error 0.1519
|
2.638 score on a scale
Standard Error 0.1155
|
2.712 score on a scale
Standard Error 0.1427
|
|
Ocular Itching
Visit 4b, 7 min Post-CAC
|
1.181 score on a scale
Standard Error 0.1462
|
1.656 score on a scale
Standard Error 0.1532
|
2.644 score on a scale
Standard Error 0.1249
|
2.755 score on a scale
Standard Error 0.1390
|
|
Ocular Itching
Visit 5, 3 min Post-CAC
|
0.495 score on a scale
Standard Error 0.0918
|
0.594 score on a scale
Standard Error 0.1296
|
1.915 score on a scale
Standard Error 0.1307
|
2.070 score on a scale
Standard Error 0.1319
|
|
Ocular Itching
Visit 5, 5 min Post-CAC
|
0.601 score on a scale
Standard Error 0.0930
|
0.791 score on a scale
Standard Error 0.1350
|
1.973 score on a scale
Standard Error 0.1255
|
2.345 score on a scale
Standard Error 0.1378
|
|
Ocular Itching
Visit 5, 7 min Post-CAC
|
0.618 score on a scale
Standard Error 0.1083
|
0.972 score on a scale
Standard Error 0.1548
|
1.920 score on a scale
Standard Error 0.1394
|
2.358 score on a scale
Standard Error 0.1221
|
PRIMARY outcome
Timeframe: Assessed at Visit 4b on day 1 (duration of action CAC at 8 hours post-instillation of study medication) and Visit 5 on day 15 (onset of action CAC at 15 minutes post-instillation of study medication).Conjunctival redness score (measured on a 0-4unit scale, allowing half-unit increments; average score of the subject's two eyes) assessed by investigator at 7 (±1), 15 (±1), and 20 (±1) minutes post-CAC.
Outcome measures
| Measure |
Combination
n=47 Participants
Brimonidine tartrate 0.025% / ketotifen fumarate 0.035% combination ophthalmic solution administered bilaterally
|
Ketotifen Fumarate
n=48 Participants
Ketotifen fumarate ophthalmic solution 0.035% administered bilaterally
|
Brimonidine Tartrate
n=47 Participants
Brimonidine tartrate ophthalmic solution 0.025% administered bilaterally
|
Vehicle
n=46 Participants
Vehicle ophthalmic solution administered bilaterally
|
|---|---|---|---|---|
|
Conjunctival Redness
Visit 4b, 7 min Post-CAC
|
1.372 score on a scale
Standard Error 0.1088
|
1.844 score on a scale
Standard Error 0.0895
|
1.883 score on a scale
Standard Error 0.1083
|
2.155 score on a scale
Standard Error 0.0850
|
|
Conjunctival Redness
Visit 4b, 15 min Post-CAC
|
1.617 score on a scale
Standard Error 0.1204
|
2.130 score on a scale
Standard Error 0.0939
|
2.069 score on a scale
Standard Error 0.1189
|
2.321 score on a scale
Standard Error 0.0934
|
|
Conjunctival Redness
Visit 4b, 20 min Post-CAC
|
1.649 score on a scale
Standard Error 0.1165
|
2.146 score on a scale
Standard Error 0.0953
|
1.984 score on a scale
Standard Error 0.1296
|
2.315 score on a scale
Standard Error 0.0961
|
|
Conjunctival Redness
Visit 5, 7 min Post-CAC
|
0.591 score on a scale
Standard Error 0.0846
|
1.393 score on a scale
Standard Error 0.0944
|
1.005 score on a scale
Standard Error 0.1300
|
2.052 score on a scale
Standard Error 0.1143
|
|
Conjunctival Redness
Visit 5, 15 min Post-CAC
|
0.765 score on a scale
Standard Error 0.1043
|
1.662 score on a scale
Standard Error 0.1036
|
1.069 score on a scale
Standard Error 0.1338
|
2.268 score on a scale
Standard Error 0.1111
|
|
Conjunctival Redness
Visit 5, 20 min Post-CAC
|
0.735 score on a scale
Standard Error 0.1012
|
1.727 score on a scale
Standard Error 0.1088
|
1.021 score on a scale
Standard Error 0.1343
|
2.238 score on a scale
Standard Error 0.1182
|
Adverse Events
Combination
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ketotifen Fumarate
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Brimonidine Tartrate
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Combination
n=47 participants at risk
Brimonidine tartrate 0.025% / ketotifen fumarate 0.035% combination ophthalmic solution administered bilaterally
|
Ketotifen Fumarate
n=48 participants at risk
Ketotifen fumarate ophthalmic solution 0.035% administered bilaterally
|
Brimonidine Tartrate
n=47 participants at risk
Brimonidine tartrate ophthalmic solution 0.025% administered bilaterally
|
Vehicle
n=46 participants at risk
Vehicle ophthalmic solution administered bilaterally
|
|---|---|---|---|---|
|
Eye disorders
Visual Acuity reduced
|
2.1%
1/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/48 • Assessed through the study, approximately 10 weeks
|
2.1%
1/47 • Assessed through the study, approximately 10 weeks
|
2.2%
1/46 • Assessed through the study, approximately 10 weeks
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/48 • Assessed through the study, approximately 10 weeks
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
2.2%
1/46 • Assessed through the study, approximately 10 weeks
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/48 • Assessed through the study, approximately 10 weeks
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
2.2%
1/46 • Assessed through the study, approximately 10 weeks
|
|
Eye disorders
Eye pruritus
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/48 • Assessed through the study, approximately 10 weeks
|
2.1%
1/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/46 • Assessed through the study, approximately 10 weeks
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
2.1%
1/48 • Assessed through the study, approximately 10 weeks
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/46 • Assessed through the study, approximately 10 weeks
|
|
Infections and infestations
Localised infection
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/48 • Assessed through the study, approximately 10 weeks
|
2.1%
1/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/46 • Assessed through the study, approximately 10 weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
2/47 • Assessed through the study, approximately 10 weeks
|
2.1%
1/48 • Assessed through the study, approximately 10 weeks
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/46 • Assessed through the study, approximately 10 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
2.1%
1/48 • Assessed through the study, approximately 10 weeks
|
2.1%
1/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/46 • Assessed through the study, approximately 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
2.1%
1/48 • Assessed through the study, approximately 10 weeks
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/46 • Assessed through the study, approximately 10 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/48 • Assessed through the study, approximately 10 weeks
|
2.1%
1/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/46 • Assessed through the study, approximately 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic pharyngitis
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/48 • Assessed through the study, approximately 10 weeks
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
2.2%
1/46 • Assessed through the study, approximately 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/48 • Assessed through the study, approximately 10 weeks
|
2.1%
1/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/46 • Assessed through the study, approximately 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
2.1%
1/48 • Assessed through the study, approximately 10 weeks
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/46 • Assessed through the study, approximately 10 weeks
|
|
General disorders
Instillation site foreign body sensation
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
2.1%
1/48 • Assessed through the study, approximately 10 weeks
|
0.00%
0/47 • Assessed through the study, approximately 10 weeks
|
0.00%
0/46 • Assessed through the study, approximately 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place