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The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective for treatment of signs and symptoms of dry eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-38583 0.05% | Experimental | AL-38583 ophthalmic solution 0.05%, 1 drop per eye, 3 times a day, for 35 days |
|
| AL-38583 0.10% | Experimental | AL-38583 ophthalmic solution 0.10%, 1 drop per eye, 3 times a day, for 35 days |
|
| AL-38583 vehicle | Placebo Comparator | Inactive ingredients used as a placebo comparator, 1 drop per eye, 3 times a day, for 35 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-38583 ophthalmic solution 0.05% | Drug |
| ||
| AL-38583 ophthalmic solution 0.10% |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in sodium fluorescein corneal staining score | Baseline, up to Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in phenol red thread length | Baseline, up to Day 35 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ravaughn Williams, OD, MS | Alcon Research | Study Director |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Drug |
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| AL-38583 vehicle | Drug | Inactive ingredients used as a placebo comparator |
|