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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
159
Investigational ophthalmic solution applied topically to the eye with a dropper bottle
Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle
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
Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1
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.
Time frame: Day 1: Pretreatment; 15 minutes post-treatment
Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1
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.
Time frame: Day 1: Pretreatment; 10 hours (600 minutes) post-treatment
Mean change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1
Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).
Time frame: Day 1: Pretreatment; 1 minute post-treatment
Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1
Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).
Time frame: Day 1: Pretreatment; 8 hours (480 minutes) post-treatment
Mean change from baseline in investigator-assessed ocular redness at 12 hours (720 minutes) post-instillation on Day 1
Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).
Time frame: Day 1: Pretreatment; 12 hours (720 minutes) post-treatment
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Piedmont Eye Center
Lynchburg, Virginia, United States