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

• Status: Completed
• Trial end date: 2020-09-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allysta Pharmaceutical
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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