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NCT05815758 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution
A Phase 3 study of Allergic Conjunctivitis, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 512
- Enrollment target
- 7
- Study locations
NCT05815758 is a Phase 3 study of Allergic Conjunctivitis that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 512 participants, above the 109-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (370% higher). The trial reports 7 study locations across 6 states.
The verdict
NCT05815758, a Phase 3 study of Allergic Conjunctivitis, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 512 participants
- Enrollment target
- 7
- Study locations
Study Summary
To compare the safety and tolerability of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ophthalmic solution versus its vehicle in healthy adult subjects and in pediatric subjects.
Conditions Studied
Interventions
- DRUG Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution (Combo)
- DRUG Vehicle of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% ophthalmic solution
Study Locations (7)
Virginia
- 106- Emerson Research Institute, Inc. - Falls Church
- 102 - Piedement Eye Center - Lynchburg
Arizona
- 104- Arizona Eye Center - Chandler
Maryland
- 103- Seidenberg Protzko Eye Associates - Havre de Grace
Massachusetts
- 101 - Andover Eye Associates - Andover
North Carolina
- 105- NC Eye Associates - Apex
Tennessee
- 107 Total Eye Care, PA - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 512 participants |
| Start Date | 2023-04-20 |
| Est. Completion | 2023-09-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05815758
The ClinicalTrials.gov registry entry for NCT05815758 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 512 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 109-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (370% higher). The listed sponsor is Bausch & Lomb Incorporated, which has 174 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Allergic Conjunctivitis appearing as the primary indexed condition, and to 2 interventions - of which Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution (Combo) is the first listed.
NCT05815758 reports 7 study locations spanning 6 distinct geographic areas - top geographies include Virginia, Arizona, Maryland.
Frequently Asked Questions
What is clinical trial NCT05815758 about?
NCT05815758 is a clinical study titled "Evaluation of the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution". To compare the safety and tolerability of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ophthalmic solution versus its vehicle in healthy adult subjects and in pediatric subjects.
What is the current status of trial NCT05815758?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 512 participants. The study started on 2023-04-20. Estimated completion is 2023-09-18.
What conditions does trial NCT05815758 study?
This clinical trial studies the following conditions: Allergic Conjunctivitis.
What interventions are being tested in trial NCT05815758?
The interventions under investigation include: Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution (Combo) (DRUG), Vehicle of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% ophthalmic solution (DRUG).
Who is sponsoring clinical trial NCT05815758?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05815758 being conducted?
This trial has 7 study locations across Arizona, Maryland, Massachusetts, North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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