Phase 1/2a Safety and Efficacy of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

A Phase 1/2a, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Exploratory Activity of Two Concentrations of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

Clinical Trial Evaluating the Safety and Tolerability of ALY688 in Subjects with Dry Eye Disease

This is a multi-center, randomized, double-masked Phase 1/2a trial designed to evaluate the safety and tolerability of ALY688 Ophthalmic Solution in subjects with moderate to mildly severe dry eye for 8 weeks with 6 scheduled clinic visits.

Inclusion Criteria:

• Dry eye disease for > 3 months meeting specific sign and symptom criteria
• Best correct 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 infectious 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