Efficacy and Safety of FID 123472 Ophthalmic Solution for Ocular Redness in Adults (NCT07531043) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Efficacy and Safety of FID 123472 Ophthalmic Solution for Ocular Redness in Adults
United States230 participantsStarted 2026-10
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of an investigational ophthalmic solution in adults with ocular redness due to minor eye irritations.
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.
Key Inclusion Criteria:
* Capable of giving signed informed consent and comply with the requirements listed in the Informed Consent Form.
* Willing and able to follow all instructions and attend all study visits.
* History of redness relief eyedrop use within the last 6 months, or an interest in using over-the-counter redness relief drops, or would benefit from the use of redness relief drops in the investigator's opinion.
* Baseline investigator-assessed ocular redness score of greater than 1 on a 5-point scale in both eyes prior to randomization on Day 1 (Visit 2).
* Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
* Known contraindications or sensitivity to the use of any of the investigational product(s) or their components, or any other medication required by the protocol.
* Ocular surgical intervention within 6 months prior to Visit 1 or during the study.
* Any ocular condition that, in the opinion of the investigator, may compromise the subject's safety or study specific parameters.
* Use of any of the prohibited medications or devices as specified in the study protocol.
* Out-of-range vital signs (blood pressure and/or pulse rate) as defined in the study protocol.
* Abnormal intraocular pressure.
* Other protocol-defined exclusion criteria may apply.
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
Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2)