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NCT07531043
Efficacy and Safety of FID 123472 Ophthalmic Solution for Ocular Redness in Adults
Conditions: Ocular Hyperemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 230
Sponsor: Alcon Research
Location: Contact Alcon Call Center for Trial Locations Fort Worth Texas
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07531043). StuddyBuddy aggregates publicly available trial information.