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 | Completed Phase 3 FDA Drug

• 1 other identifier: BL-CO01-LUMHA-1301
• Study Type: interventional
• Target: 578
• Locations: 1 country
• Sites: 11

Brief 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

Outcome Measures

Primary Outcomes (1)

• Ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator at Visit 2 (Day 1)

  Ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator at Visit 2 (Day 1) prior to investigational drug instillation and after investigational drug instillation at 5(+1) minutes, 15(+1) minutes, 30(+1) minutes, 60(+10) minutes, 90(+10) minutes, 120(+15) minutes, 180(+15) minutes, 240(+15) minutes

  Assessed at Visit 2 (Day 1) prior to investigational drug instillation and after investigational drug instillation at 5(+1) minutes, 15(+1) minutes, 30(+1) minutes, 60(+10) minutes, 90(+10) minutes, 120(+15) minutes, 180(+15) minutes, 240(+15) minutes

Secondary Outcomes (4)

• Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator at Visit 2 (Day 1)

  Assessed at Visit 2 (Day 1) after investigational drug instillation evaluated hierarchically at: 1 (+0.5) minute, 360 (+15) minutes and 480 (+15) minutes

• Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the Investigator after investigational drug instillation evaluated hierarchically at Visit 3 (Day 15)

  Assessed at Visit 3 (Day 15) 5 (+1) minutes and 15 (+1) minutes

• Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the Investigator after investigational drug instillation evaluated hierarchically at Visit 4 (Day 29)

  Assessed at Visit 4 (Day 29) 5 (+1) minutes and 15 (+1) minutes

• Change from pre-instillation ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator after investigational drug instillation at Visit 2 (Day 1)

  Assessed at Visit 2 (Day 1) evaluated hierarchically at 0.5 (+0.25) minute and 600 (+15) minutes

Study Arms (2)

Brimonidine tartrate ophthalmic solution 0.025% with sodium hyaluronate (BTOS-HA)

EXPERIMENTAL

Drug: BTOS-HA

Brimonidine tartrate ophthalmic solution 0.025%

ACTIVE COMPARATOR

Drug: Lumify®

Interventions

BTOS-HA DRUG

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

Brimonidine tartrate ophthalmic solution 0.025% with sodium hyaluronate (BTOS-HA)

Lumify® DRUG

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

Brimonidine tartrate ophthalmic solution 0.025%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily provide written informed consent
• ≥18 years of age
• Able and willing to follow instructions, including participation in all trial assessments and visits
• History of vasoconstrictor (redness relief drops) use within the last 6 months, or a desire to use over the counter (OTC) vasoconstrictors for redness relief
• Able to self-administer eye drops satisfactorily
• A calculated best-corrected (if necessary) visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart
• Show a baseline redness score \>1 in both eyes as scored by the investigator using the Investigator Ocular Redness Scale (range 0-4)
• Stable ocular health at Visit 2 (Day 1), (defined as no ocular conditions requiring therapy or surgical intervention during the study).

You may not qualify if:

• Known contraindications or sensitivity to the use of any of the investigational drug(s) or their components, or any other medications required by the protocol
• Ocular surgery within 3 months prior to screening and/or a history of refractive surgery within the past 6 months, and/ or planned surgery (ocular or systemic) during the trial period or within 30 days after the study period
• Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection
• Use any of the following disallowed medications during the period indicated prior to randomization or planned use during the study:
• All topical ophthalmic agents including artificial tear products, eye whiteners (e.g., vasoconstrictors), ocular decongestants, ocular antihistamines, ocular corticosteroids, dilating drops (excluding dilated ophthalmoscopy exam at Visit 2), and contact lenses: 5 days
• Systemic antihistamines or decongestants: 7 days
• Systemic corticosteroids or cancer chemotherapy, and/or any other systemic medications which the investigator feels may confound study data, put the subject at risk or interfere with subject's study participation: 14 days
• Have prior (within 7 days of beginning investigational drug) or currently active significant illness that could compromise participation, in the opinion of the investigator
• Have prior (within 30 days of beginning investigational drug) or anticipated concurrent use of an investigational drug or device during the study period
• Have an ocular or systemic condition or a situation which, in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation (e.g., blepharitis, active ocular allergies, rosacea with peri-ocular involvement, uncontrolled diabetes, hypertension, or cardiovascular disease).
• Have a diagnosis of ocular hypertension or glaucoma at screening
• Any female who is nursing, lactating, pregnant, planning a pregnancy, or has a positive urine pregnancy test at Visit 2 (Day 1).
• Any female of childbearing potential (FOCBP) who is unwilling to: a) agree to have urine pregnancy testing performed at Visit 2 (Day 1), and b) agree to use at least 1 medically acceptable form of birth control for at least 14 days prior to the first dose of study drug at Visit 2 (Day 1), throughout the study duration, and for 1 month after the last dose of investigational drug at Visit 4 (Day 29) NOTE: FOCBP include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy)
• NOTE: Acceptable forms of birth control include:
• Mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom)

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (11)

Site 102

Glendale, California, 91204, United States

Location

Site 104

Newport Beach, California, 92663, United States

Location

Site 111

Northbrook, Illinois, 60062, United States

Location

Site 109

Pittsburg, Kansas, 66762, United States

Location

Site 106

Louisville, Kentucky, 40206, United States

Location

Site 103

Andover, Massachusetts, 01810, United States

Location

Site 108

Garner, North Carolina, 27529, United States

Location

Site 107

Shelby, North Carolina, 28150, United States

Location

Site 112

Cranberry Township, Pennsylvania, 16066, United States

Location

Site 101

Memphis, Tennessee, 38119, United States

Location

Site 105

Smyrna, Tennessee, 37167, United States

Location

MeSH Terms

Interventions

Brimonidine Tartrate

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Double masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: May 22, 2025
• Primary Completion: June 29, 2025
• Study Completion: June 29, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)