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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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