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

Phase 2CompletedNCT04201574

Allysta Pharmaceutical138 enrolled

Overview

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

This is a multi-center, randomized, double-masked Phase 1/2a trial designed to evaluate the safety and tolerability of ALY688 Ophthalmic Solution in subjects with moderate to mildly severe dry eye for 8 weeks with 6 scheduled clinic visits.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

138

Conditions

Dry Eye Disease

Interventions

ALY688 0.1%DRUG

ALY688 0.1% Ophthalmic Solution

ALY688 0.4%DRUG

ALY688 0.4% Ophthalmic Solution

VehicleDRUG

Vehicle Ophthalmic Solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Allysta Pharmaceuticals

Bellevue, Washington, United States

Outcomes

Primary Outcomes

Number of Subjects With Adverse Events

Subjects reporting any treatment-emergent adverse events

Time frame: 8 weeks

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

Time frame: 8 weeks

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

Time frame: 8 weeks

Secondary Outcomes

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

Time frame: 8 weeks

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

Time frame: 8 weeks

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

Time frame: 8 weeks

Conjunctival Hyperemia Grading

Data from ClinicalTrials.gov

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