An Evaluation of the Efficacy and Safety of FID 123472 Ophthalmic Solution for the Reduction of O… (NCT07531043) | Clinical Trial Compass
Not Yet RecruitingPhase 3
An Evaluation of the Efficacy and Safety of FID 123472 Ophthalmic Solution for the Reduction of Ocular Redness
United States240 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 range18 Years
SexALL
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Key Inclusion Criteria:
* Capable of giving signed informed consent and complying 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 has an interest in using redness relief drops, or would benefit from the use of redness relief drops in the investigator's opinion.
* Best corrected visual acuity at distance of 0.3 logarithm Minimum Angle of Resolution or better in each eye.
* Baseline ocular redness score greater than 1 unit in both eyes using the 0-4 Ora Calibra® Ocular Hyperemia Scale.
* Stable ocular health.
* Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria:
* Known contraindications or sensitivity to the use of any of the study treatment(s) or their components, or any other medication required by the protocol.
* Ocular surgical interventions within 6 months prior to Visit 1 or during the study.
* Ocular conditions that, in the opinion of the investigator, could affect the subject's safety or study parameters.
* Use of prohibited medications, devices, or treatments as specified in the protocol;
* Ocular or systemic conditions or situations 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.
* Currently pregnant or breastfeeding; planning a pregnancy or planning to breastfeed during t…
What they're measuring
1
Mean change from baseline (pretreatment) in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1