Clinical trial NCT06444529: A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness
Official title: A Double-Masked Comparison of Apraclonidine Hydrochloride Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Redness
Keywords: Eye redness
Irritated eyes
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-06-05
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1
timeFrame: Day 1: Pretreatment; 15 minutes post-treatment
measure: Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1
timeFrame: Day 1: Pretreatment; 10 hours (600 minutes) post-treatment
Secondary outcomes:
measure: Mean change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1
timeFrame: Day 1: Pretreatment; 1 minute post-treatment
measure: Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1
timeFrame: Day 1: Pretreatment; 8 hours (480 minutes) post-treatment
measure: Mean change from baseline in investigator-assessed ocular redness at 12 hours (720 minutes) post-instillation on Day 1
timeFrame: Day 1: Pretreatment; 12 hours (720 minutes) post-treatment
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Garner
country: United States
facility: Oculus Research, Inc.
state: North Carolina
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Falls Church
country: United States
facility: Emerson Clinical Research Institute, Inc.
state: Virginia
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
Study officials:
affiliation: Alcon Research, LLC
name: Principal Clinical Trial Lead, Pharma
role: STUDY_DIRECTOR
References: