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NCT05591755 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination in Adults With Seasonal Allergic Conjunctivitis
A Phase 3 study of Seasonal Allergic Conjunctivitis, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 229
- Enrollment target
- 6
- Study locations
NCT05591755: Completed Phase 3 study of Seasonal Allergic Conjunctivitis, sponsored by Bausch & Lomb Incorporated.
NCT05591755 is a Phase 3 study of Seasonal Allergic Conjunctivitis that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 229 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05591755, a Phase 3 study of Seasonal Allergic Conjunctivitis, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 229 participants
- Enrollment target
- 6
- Study locations
Study Summary
To evaluate the efficacy of Combo compared to its individual components and compared to vehicle in a population of subjects with seasonal allergic conjunctivitis.
Primary Outcome
Ocular itching score evaluated by the subject at 10(±1), 30(±1), 60(±5), 360(±5), 420(±5), and 480(±5) minutes post-instillation of assigned IP at Visit 2 (0-4 scale, allowing half unit increments), with 4 is the worse outcome.
Conditions Studied
Interventions
- DRUG Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
- DRUG Ketotifen fumarate ophthalmic solution 0.035%
- DRUG Brimonidine tartrate ophthalmic solution 0.025%
- DRUG Experimental: Vehicle ophthalmic solution
Study Locations (6)
Tennessee
- 105 - Advancing Vision Research - Goodlettsville
- 102 Total Eye Care, PA - Memphis
Virginia
- 108 Emerson Clinical Research Institute Inc. - Falls Church
- 107 Virginia Eye Institute - Richmond
Kentucky
- 104 Butchertown Clinical Trials - Louisville
Massachusetts
- 101 Andover Eye Associates - Andover
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2022-11-18 |
| Est. Completion | 2023-08-09 |
| Phase | Phase 3 |
What the finished NCT05591755 record still lists
NCT05591755 is an interventional study that assigns participants to a tested intervention. The registered 229 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Seasonal Allergic Conjunctivitis appearing as the primary indexed condition, and to 4 interventions - of which Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution is the first listed.
NCT05591755 lists 6 locations in 4 states (Tennessee, Virginia, Kentucky).
Frequently Asked Questions
What is clinical trial NCT05591755 about?
NCT05591755 is a clinical study titled "Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination in Adults With Seasonal Allergic Conjunctivitis". To evaluate the efficacy of Combo compared to its individual components and compared to vehicle in a population of subjects with seasonal allergic conjunctivitis.
What is the current status of trial NCT05591755?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 229 participants. The study started on 2022-11-18. Estimated completion is 2023-08-09.
What conditions does trial NCT05591755 study?
This clinical trial studies the following conditions: Seasonal Allergic Conjunctivitis.
What interventions are being tested in trial NCT05591755?
The interventions under investigation include: Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution (DRUG), Ketotifen fumarate ophthalmic solution 0.035% (DRUG), Brimonidine tartrate ophthalmic solution 0.025% (DRUG), Experimental: Vehicle ophthalmic solution (DRUG).
Who is sponsoring clinical trial NCT05591755?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05591755 being conducted?
This trial has 6 study locations across Kentucky, Massachusetts, Tennessee, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05591755's enrollment target sits among peer trials
229 1309th of 2000 higher than 692 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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