10 and older, any sex, with Allergic Conjunctivitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Ocular ItchingPrimary· 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.
Visit 4b, 3 min Post-CAC
Group
Value
95% CI
Combination
1.176
± 0.1464
Ketotifen Fumarate
1.708
± 0.1487
Brimonidine Tartrate
2.426
± 0.1330
Vehicle
2.362
± 0.1512
Visit 4b, 5 min Post-CAC
Group
Value
95% CI
Combination
1.287
± 0.1507
Ketotifen Fumarate
1.688
± 0.1519
Brimonidine Tartrate
2.638
± 0.1155
Vehicle
2.712
± 0.1427
Visit 4b, 7 min Post-CAC
Group
Value
95% CI
Combination
1.181
± 0.1462
Ketotifen Fumarate
1.656
± 0.1532
Brimonidine Tartrate
2.644
± 0.1249
Vehicle
2.755
± 0.1390
Visit 5, 3 min Post-CAC
Group
Value
95% CI
Combination
0.495
± 0.0918
Ketotifen Fumarate
0.594
± 0.1296
Brimonidine Tartrate
1.915
± 0.1307
Vehicle
2.070
± 0.1319
Visit 5, 5 min Post-CAC
Group
Value
95% CI
Combination
0.601
± 0.0930
Ketotifen Fumarate
0.791
± 0.1350
Brimonidine Tartrate
1.973
± 0.1255
Vehicle
2.345
± 0.1378
Visit 5, 7 min Post-CAC
Group
Value
95% CI
Combination
0.618
± 0.1083
Ketotifen Fumarate
0.972
± 0.1548
Brimonidine Tartrate
1.920
± 0.1394
Vehicle
2.358
± 0.1221
Conjunctival RednessPrimary· 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.
Visit 4b, 7 min Post-CAC
Group
Value
95% CI
Combination
1.372
± 0.1088
Ketotifen Fumarate
1.844
± 0.0895
Brimonidine Tartrate
1.883
± 0.1083
Vehicle
2.155
± 0.0850
Visit 4b, 15 min Post-CAC
Group
Value
95% CI
Combination
1.617
± 0.1204
Ketotifen Fumarate
2.130
± 0.0939
Brimonidine Tartrate
2.069
± 0.1189
Vehicle
2.321
± 0.0934
Visit 4b, 20 min Post-CAC
Group
Value
95% CI
Combination
1.649
± 0.1165
Ketotifen Fumarate
2.146
± 0.0953
Brimonidine Tartrate
1.984
± 0.1296
Vehicle
2.315
± 0.0961
Visit 5, 7 min Post-CAC
Group
Value
95% CI
Combination
0.591
± 0.0846
Ketotifen Fumarate
1.393
± 0.0944
Brimonidine Tartrate
1.005
± 0.1300
Vehicle
2.052
± 0.1143
Visit 5, 15 min Post-CAC
Group
Value
95% CI
Combination
0.765
± 0.1043
Ketotifen Fumarate
1.662
± 0.1036
Brimonidine Tartrate
1.069
± 0.1338
Vehicle
2.268
± 0.1111
Visit 5, 20 min Post-CAC
Group
Value
95% CI
Combination
0.735
± 0.1012
Ketotifen Fumarate
1.727
± 0.1088
Brimonidine Tartrate
1.021
± 0.1343
Vehicle
2.238
± 0.1182
Adverse events — posted to ClinicalTrials.gov
Time frame: Assessed through the study, approximately 10 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
To evaluate the efficacy of Combo (Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution) compared to its individual components and vehicle in a population of subjects with allergic conjunctivitis:
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Bausch & Lomb Incorporated
Last refreshed: 14 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05579730.