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The purpose of this study is to evaluate the efficacy and safety of an investigational ophthalmic solution in adults with ocular redness due to minor eye irritations.
Eligible subjects will be expected to attend a total of 3 in-office study visits over a period of approximately 1 week. Subjects will receive a single dose of the study treatment in each eye on Day 1 (Visit 2). Eye redness will be assessed before and after instillations at prespecified timepoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free | Experimental | One drop in each eye on Day 1 (single dose) |
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| Vehicle | Placebo Comparator | One drop in each eye on Day 1 (single dose) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free | Drug | Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free (UDPF) formulation |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2) | Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint. | Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1) |
| Change from baseline in investigator-assessed ocular redness at 840 minutes (14 hours) post-instillation on Day 2 (Visit 3) | Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint. | Baseline (Day 1 pretreatment); 840 minutes (14 hours) post-instillation (Day 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) | Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alcon Call Center | Contact | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Pharma | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
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| Label | URL |
|---|---|
| Educational | View source |
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| ID | Term |
|---|---|
| C016986 | apraclonidine |
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| Vehicle | Drug | Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free (UDPF) formulation |
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| Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1) |
| Change from baseline in investigator-assessed ocular redness at 960 minutes (16 hours) post-instillation on Day 2 (Visit 3) | Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). | Baseline (Day 1 pretreatment); 960 minutes (16 hours) post-instillation (Day 2) |