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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: Completed Phase 3 study of Allergic Conjunctivitis, sponsored by Bausch & Lomb Incorporated.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
TEAE is defined as any untoward medical occurrence or undesirable event(s) that begins or worsens following administration of the study drug, whether or not considered related to the treatment by the Investigator. A TEAE is considered serious if, in the view of the Investigator or Sponsor, it results in any of the following outcomes: death, a life-threatening TEAE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congeni
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 |
What the finished NCT05815758 record still lists
NCT05815758 is an interventional study that assigns participants to a tested intervention. The registered 512 participants enrollment target is mid-sized for trials with a published cap, above the 109-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (370% higher).
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 lists 7 locations in 6 states (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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