Evaluation of the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution
Public ClinicalTrials.gov record NCT05815758. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution, Used Two Times Daily in Healthy Adult Subjects and in Pediatric Subjects With a History or Family History of Atopic Disease (Including Allergic Conjunctivitis)
Study identification
- NCT ID
- NCT05815758
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Bausch & Lomb Incorporated
- Industry
- Enrollment
- 512 participants
Conditions and interventions
Conditions
Interventions
- 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
Drug
Eligibility (public fields only)
- Age range
- 5 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 19, 2023
- Primary completion
- Sep 17, 2023
- Completion
- Sep 17, 2023
- Last update posted
- Jul 9, 2025
2023
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 104- Arizona Eye Center | Chandler | Arizona | 85225 | — |
| 103- Seidenberg Protzko Eye Associates | Havre de Grace | Maryland | 21078 | — |
| 101 - Andover Eye Associates | Andover | Massachusetts | 01810 | — |
| 105- NC Eye Associates | Apex | North Carolina | 27502 | — |
| 107 Total Eye Care, PA | Memphis | Tennessee | 38119 | — |
| 106- Emerson Research Institute, Inc. | Falls Church | Virginia | 22046 | — |
| 102 - Piedement Eye Center | Lynchburg | Virginia | 24502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05815758, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 9, 2025 · Synced Jul 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05815758 live on ClinicalTrials.gov.