Recruiting
Phase 3

Ophthalmic Solution

Sponsor:

Alcon Research

Code:

NCT07578363

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 caused by minor eye irritations.

Conditions

Ocular Hyperemia

Study ID

NCT07578363

Start date

Sep 27, 2026

Status verified date

Oct, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Jan, 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 ocular redness score of 0.5 unit or higher in at least one eye at Visit 1 and greater than 1 unit on a 5-point scale in both eyes prior to randomization at Visit 2.
  • 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.
  • Any ocular condition that, in the opinion of the investigator, may compromise the subject's safety or study parameters.
  • Use of prohibited medications, devices, or treatments as specified in the 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

178 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, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56. On the day of Day 56, subjects will receive the last dose in-office.

placebo comparator: Vehicle

One drop in each eye on Day 1, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56. On the day of Day 56, subjects will receive the last dose in-office.

Interventions

Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free

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

Vehicle

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

Primary outcome measure

  • Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 [ Time Frame: Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1) ]
  • Change from baseline in investigator-assessed ocular redness at 600 minutes post-instillation on Day 1 [ Time Frame: Baseline (Day 1 pretreatment); 600 minutes post-instillation (Day 1) ]

Central Contacts and Locations

Central contacts

Alcon Call Center

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

Locations

Oculus Research, Inc.

Recruiting

Garner, North Carolina, United States, 27529

Total Eye Care PA

Recruiting

Memphis, Tennessee, United States, 38119

Piedmont Eye Center

Recruiting

Lynchburg, Virginia, United States, 24501

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.