ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease
Phase 2
Completed
- Conditions
- Dry Eye
- Interventions
- Drug: ALY688 Ophthalmic Solution
- Registration Number
- NCT04899518
- Lead Sponsor
- Allysta Pharmaceutical
- Brief Summary
Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with Dry Eye Disease
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 922
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Ophthalmic Solution ALY688 Ophthalmic Solution - ALY688 Ophthalmic Solution Concentration 1 ALY688 Ophthalmic Solution - ALY688 Ophthalmic Solution Concentration 2 ALY688 Ophthalmic Solution -
- Primary Outcome Measures
Name Time Method Corneal fluorescein staining 8 weeks Difference between ALY688 Ophthalmic Solution 0.4% and vehicle
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Allysta Pharmaceuticals
🇺🇸Bellevue, Washington, United States