Back to resultsALY688 Ophthalmic Solution in Subjects With Dry Eye Disease (OASIS-1)
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALY688 Ophthalmic Solution
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
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
Sites / Locations
- Allysta Pharmaceuticals
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Vehicle Ophthalmic Solution
ALY688 Ophthalmic Solution Concentration 1
ALY688 Ophthalmic Solution Concentration 2
Arm Description
Outcomes
Primary Outcome Measures
Corneal fluorescein staining
Difference between ALY688 Ophthalmic Solution 0.4% and vehicle
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04899518
Brief Title
ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease
Acronym
OASIS-1
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
March 14, 2023 (Actual)
Study Completion Date
March 14, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allysta Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
922 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vehicle Ophthalmic Solution
Arm Type
Placebo Comparator
Arm Title
ALY688 Ophthalmic Solution Concentration 1
Arm Type
Experimental
Arm Title
ALY688 Ophthalmic Solution Concentration 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ALY688 Ophthalmic Solution
Intervention Description
Ophthalmic Solution
Primary Outcome Measure Information:
Title
Corneal fluorescein staining
Description
Difference between ALY688 Ophthalmic Solution 0.4% and vehicle
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Allysta Pharmaceuticals
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease
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