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A Study Comparing the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% With Sodium Hyaluronate Relative to Lumify in Adult Subjects With Ocular Redness

NCT06803654 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 578

Last updated 2025-07-09

No results posted yet for this study

Summary

To demonstrate the efficacy of BTOS-HA as non inferior to Lumify for treating ocular redness in a population of adult subjects.

Conditions

  • Ocular Redness

Interventions

DRUG

BTOS-HA

Brimonidine tartrate ophthalmic solution 0.025% with sodium hyaluronate (BTOS-HA) administered as 1 topical ocular drop instilled into each eye (OU), 4 times daily (QID), approximately 4 hours apart

DRUG

Lumify®

Brimonidine tartrate ophthalmic solution 0.025%, administered as 1 topical ocular drop instilled into each eye (OU), 4 times daily (QID), approximately 4 hours apart

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-22
Primary Completion
2025-06-29
Completion
2025-06-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06803654 on ClinicalTrials.gov