Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of an investigational ophthalmic solution in adults with ocular redness caused by minor eye irritations.
Eligible subjects will be expected to attend a total of 6 in-office study visits over a period of approximately 10 weeks. Subjects will receive a single dose of study treatment in each eye (either Apraclonidine 0.125% UDPF or Vehicle) on Day 1, after which subjects will be instructed to self-administer one drop in each eye twice daily at home for a total of approximately 8 weeks (Days 2-55), with the last dose administered on Day 56 in office. Subjects will then return for the final study visit on Day 63, following a 1-week treatment discontinuation. Eye redness will be assessed before and after instillation at prespecified timepoints.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free | Experimental | One drop in each eye on Day 1, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56. On the day of Day 56, subjects will receive the last dose in-office. |
|
| Vehicle | Placebo Comparator | One drop in each eye on Day 1, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56. On the day of Day 56, subjects will receive the last dose in-office. |
|
| 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 formulation |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 | 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 600 minutes post-instillation on Day 1 | 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); 600 minutes post-instillation (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 | 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). |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
| Label | URL |
|---|---|
| Educational | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Vehicle | Drug | Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free formulation |
|
| Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1) |
| Change from baseline in investigator-assessed ocular redness at 720 minutes post-instillation on Day 1 | 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); 720 minutes post-instillation (Day 1) |
| Change from baseline in investigator-assessed ocular redness at 30 seconds post-instillation on Day 1 | 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); 30 seconds post-instillation (Day 1) |