CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 507 enrolled
Drug / intervention
Brimonidine Tartrate +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01959243
NCT01959243Phase 3Completed

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Pediatric, Adult, and Geriatric Subjects

Bausch & Lomb Incorporated·interventional·Posted Oct 9, 2013·Updated Oct 23, 2019

In Brief

A Phase 3 clinical trial evaluating Brimonidine Tartrate, Vehicle, and 2 other interventions for Hyperemia. Completed, enrolled 507 participants across 4 sites.

Detailed Summary

To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric participants. At least 51% of participants will be 40 years of age or older.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperemia
CountriesUnited States
CollaboratorsORA, Inc.

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 9, 2013
Enrollment StartFeb 22, 2014
Primary CompletionApr 23, 2014
Study CompletionJun 23, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.7 years ago

Interventions

Brimonidine Tartratedrug

Ophthalmic solution to be applied as directed.

Vehicledrug

Ophthalmic solution to be applied as directed.

Sodium Fluoresceindrug

For use as needed during the study for evaluating corneal damage.

Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USPdrug

For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.