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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apraclonidine Hydrochloride Ophthalmic Solution | Experimental | One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks |
|
| Vehicle | Placebo Comparator | One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apraclonidine Hydrochloride Ophthalmic Solution | Drug | Investigational ophthalmic solution applied topically to the eye with a dropper bottle |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day 1: Pretreatment; 10 hours (600 minutes) post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Clinical Trial Lead, Pharma | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Research Management | Glendale | California | 91204 | United States | ||
| Oculus Research, Inc. |
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| Vehicle | Drug | Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle |
|
Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). |
| 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). | Day 1: Pretreatment; 12 hours (720 minutes) post-treatment |
| Garner |
| North Carolina |
| 27529 |
| United States |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16066 | United States |
| Emerson Clinical Research Institute, Inc. | Falls Church | Virginia | 22046 | United States |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | United States |