A Study Comparing the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% With… (NCT06803654) | Clinical Trial Compass
CompletedPhase 3
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
United States578 participantsStarted 2025-05-22
Plain-language summary
To demonstrate the efficacy of BTOS-HA as non inferior to Lumify for treating ocular redness in a population of adult subjects.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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).
Exclusion criteria
✕. 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
What they're measuring
1
Ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator at Visit 2 (Day 1)
Timeframe: 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
✕. 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