Recruiting
Phase 3

Ophthalmic Solution

Sponsor:

Alcon Research

Code:

NCT07531043

Conditions

Ocular Hyperemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free

Vehicle

Study Details

Brief 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.

Conditions

Ocular Hyperemia

Study ID

NCT07531043

Start date

Sep 30, 2026

Status verified date

Oct, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

230 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free

One drop in each eye on Day 1 (single dose)

placebo comparator: Vehicle

One drop in each eye on Day 1 (single dose)

Interventions

Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free

Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free (UDPF) formulation

Vehicle

Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free (UDPF) formulation

Primary outcome measure

  • Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2) [ Time Frame: Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1) ]
  • Change from baseline in investigator-assessed ocular redness at 840 minutes (14 hours) post-instillation on Day 2 (Visit 3) [ Time Frame: Baseline (Day 1 pretreatment); 840 minutes (14 hours) post-instillation (Day 2) ]

Central Contacts and Locations

Central contacts

Alcon Call Center

1-888-451-3937alcon.medinfo@alcon.com

Locations

East West Eye Institute

Recruiting

Los Angeles, California, United States, 90013

Eye Research Foundation

Recruiting

Newport Beach, California, United States, 92663

More Information

Sponsor

Alcon Research

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

  • Ocular Redness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Alcon Research on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.