A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness
- Conditions
- Ocular Redness
- Interventions
- Registration Number
- NCT06444529
- Lead Sponsor
- Alcon Research
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 159
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Apraclonidine Hydrochloride Ophthalmic Solution Apraclonidine Hydrochloride Ophthalmic Solution One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks Vehicle Vehicle One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks
- Primary Outcome Measures
Name Time Method Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 Day 1: Pretreatment; 15 minutes post-treatment Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 10 hours post-instillation endpoint.
Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1 Day 1: Pretreatment; 10 hours (600 minutes) post-treatment Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 15 minutes post-instillation endpoint.
- Secondary Outcome Measures
Name Time Method Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1 Day 1: Pretreatment; 8 hours (480 minutes) post-treatment Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).
Mean change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 Day 1: Pretreatment; 1 minute post-treatment Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).
Mean change from baseline in investigator-assessed ocular redness at 12 hours (720 minutes) post-instillation on Day 1 Day 1: Pretreatment; 12 hours (720 minutes) post-treatment Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).
Trial Locations
- Locations (5)
Global Research Management
🇺🇸Glendale, California, United States
Oculus Research, Inc.
🇺🇸Garner, North Carolina, United States
Scott & Christie and Associates, PC
🇺🇸Cranberry Township, Pennsylvania, United States
Emerson Clinical Research Institute, Inc.
🇺🇸Falls Church, Virginia, United States
Piedmont Eye Center
🇺🇸Lynchburg, Virginia, United States