Eye drop for redness in adults: relief with a new ophthalmic solution

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial evaluates the efficacy and safety of Apraclonidine Ophthalmic Solution, 0.125% (unit-dose, preservative-free) versus its vehicle for adults with ocular redness due to minor irritations. Participants receive a single dose in each eye on Day 1 and are followed for about one week with three in-office visits to assess redness before and after administration at predefined timepoints. Eligibility requires informed consent, recent experience with redness-relief eye drops or interest in using them, and measurable ocular redness at screening and prior to dosing. Exclusion criteria include intolerance to study components, recent ocular surgery, and other protocol-defined exclusions.

Why it matters

Who can join: the full rules

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 0.5 or higher in at least one eye at Visit 1 when applicable and a score of greater than 1.0 in both eyes on a 5-point scale 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.

Where it's running

• East West Eye Institute
  Los Angeles, California, United States Recruiting
• Eye Research Foundation
  Newport Beach, California, United States Recruiting
• Kannarr Eye Care LLC
  Pittsburg, Kansas, United States Not yet recruiting
• Butchertown Clinical Trials
  Louisville, Kentucky, United States Not yet recruiting
• Andover Eye Associates
  Andover, Massachusetts, United States Not yet recruiting
• NC Eye Associates, OD, PLLC
  Apex, North Carolina, United States Not yet recruiting

Study contacts

• Study coordinator: Alcon Call Center
• Email: alcon.medinfo@alcon.com
• Phone: 1-888-451-3937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.