A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness

Alcon

Status and phase: Enrolling; Phase 3

Conditions: Ocular Redness

Treatments: Drug: Apraclonidine Hydrochloride Ophthalmic Solution; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT06444529

DEW422-C001

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of Apraclonidine Hydrochloride Ophthalmic Solution 0.125% when compared to Vehicle, in relieving redness of the eye due to minor eye irritations. This study will be conducted in the United States.

Full description

The study will consist of six (6) scheduled visits: Screening and/or Baseline Visit (Day -7 to -1), Eligibility Confirmation/Randomization/1st Treatment Visit (Day 1), Week 2 Follow-Up Visit (Day 14), Week 4 Follow-Up Visit (Day 28), Week 8 Follow-Up/Treatment Discontinuation Visit (Day 56) and Exit Visit (Day 63). The expected individual duration of participation in the study is approximately 10 weeks with approximately 56 days of exposure to the investigational product.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Capable of giving signed informed consent;
• Willing and able to follow all instructions and attend all study visits;
• Able to self-administer eye drops- in the opinion of the investigator;
• History of redness relief drop use within the last 6 months, or a desire to use over-the-counter (OTC) eye drops for redness relief;
• Females capable of becoming pregnant: Agree to urine pregnancy tests and the use of medically acceptable forms of birth control throughout the study;
• Ocular health within normal limits, including best-corrected visual acuity (BCVA) of 20/40 or better in each eye as measured using a Snellen chart;
• Ocular redness at baseline as specified in the protocol;
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Known contraindications or sensitivities to the use of any of the investigational drug(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 (i.e., could affect ocular redness, intraocular pressure, or eyelid position);
• Disallowed medications or devices as specified in the protocol;
• Planned surgery (ocular or systemic) during the study period or within 30 days after the study period;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups, including a placebo group

Apraclonidine Hydrochloride Ophthalmic Solution

Experimental group

Description:

One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks

Treatment:

Drug: Apraclonidine Hydrochloride Ophthalmic Solution

Vehicle

Placebo Comparator group

Description:

One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks

Treatment:

Drug: Vehicle