Dry Eye Disease Clinical Trial
Official title:
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
Verified date | May 2023 |
Source | Allysta Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Clinical Trial Evaluating the Safety and Tolerability of ALY688 in Subjects with Dry Eye Disease
Status | Completed |
Enrollment | 138 |
Est. completion date | September 15, 2020 |
Est. primary completion date | September 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Allysta Pharmaceuticals | Bellevue | Washington |
Lead Sponsor | Collaborator |
---|---|
Allysta Pharmaceutical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects With Adverse Events | Subjects reporting any treatment-emergent adverse events | 8 weeks | |
Primary | Eye Dryness Score (7-Day Average) | Mean change from baseline in eye dryness score (7-day average) using a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse | 8 weeks | |
Primary | Corneal Fluorescein Staining | Mean change from baseline in zonal corneal fluorescein staining score in study eye using a 0- to 4-unit clinical grading scale, with 0 being better and 4 being worse | 8 weeks | |
Secondary | Ocular Discomfort Score by Visual Analog Scale | Mean change from baseline in ocular discomfort score of 7-day average using a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse | 8 weeks | |
Secondary | Symptom Assessment in Dry Eye (SAnDE) Score Assessment | Mean change from baseline in Symptom Assessment in Dry Eye global symptom score on a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse. Global symptom score is calculated as the square root of the frequency score time the severity score per visit | 8 weeks | |
Secondary | Conjunctival Lissamine Green Staining | Mean change from baseline in zonal conjunctival lissamine green staining in study eye using a 0- to 4-unit clinical grading scale, with 0 being better and 4 being worse | 8 weeks | |
Secondary | Conjunctival Hyperemia Grading | Mean change from baseline in zonal conjunctival hyperemia in study eye using a 0- to 4-unit clinical grading scale and standardized grading photos, with 0 being better and 4 being worse | 8 weeks | |
Secondary | Tear Film Break-up Time (TBUT) | Mean change from baseline in TBUT in study eye | 8 weeks | |
Secondary | Schirmer's Test | Mean change from baseline in tear volume in study eye as assessed by unanesthetized Schirmer test | 8 weeks |
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