An Evaluation of the Efficacy and Safety of FID 123472 Ophthalmic Solution for the Reduction of Ocular Redness
Phase 3 – large-scale trial before approval
Conditions:
Ocular Hyperemia
Sponsor: Alcon Research
trial.available_in:
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Overview
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.
Description
Eligible subjects will be expected to attend a total of 3 in-office study visits over a period of approximately 1 week. Subjects will receive a single dose of the study treatment in each eye on Day 1 (Visit 2). Eye redness will be assessed before and after instillations at prespecified timepoints.
Who can participate
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 the study; has a positive urine pregnancy test during screening at Visit 1 or Visit 2.
* Other protocol-defined exclusion criteria may apply.
Interventions
Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free