Status:
COMPLETED
ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease
Lead Sponsor:
Allysta Pharmaceutical
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2023
Estimated Enrollment :
922 Patients enrolled
Trial Details
Trial ID
NCT04899518
Start Date
May 19 2021
End Date
March 14 2023
Last Update
March 16 2023
Active Locations (1)
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1
Allysta Pharmaceuticals
Bellevue, Washington, United States, 98004