ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

A Phase 2b/3, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease (OASIS-1)

Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with Dry Eye Disease

Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with Dry Eye Disease

Inclusion Criteria:

• Dry eye disease for > 3 months meeting specific sign and symptom criteria
• Best corrected visual acuity of +0.6 logMAR or better
• Willing to sign informed consent and attend study visits
• Willing to comply with contraception requirements

Exclusion Criteria:

• Unable to meet specific sign and symptom criteria
• Signs of ophthalmic allergic, inflammatory or infection conditions
• Use of contact lenses
• Anatomic abnormalities preventing accurate study assessments
• Use of medications that influence eye dryness
• Recent ophthalmic surgery
• Unwilling to suspend current treatments for dry eye disease