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

Phase 1

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: Vehicle; Drug: ALY688 0.1%; Drug: ALY688 0.4%

• Registration Number: NCT04201574
• Lead Sponsor: Allysta Pharmaceutical

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2019-12-12
• Study Start: 2019-12-16
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-17
• Primary Completion: 2020-09-15
• Study Completion: 2020-09-15
• Results First Submitted: 2021-09-18
• Status Verified: 2023-05
• Results First Submitted QC: 2023-06-19
• Last Update Submitted: 2023-06-19
• Results First Posted: 2023-06-22
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	Vehicle Ophthalmic Solution
ALY688 0.1%	ALY688 0.1%	ALY688 0.1% Ophthalmic Solution
ALY688 0.4%	ALY688 0.4%	ALY688 0.4%Ophthalmic Solution

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Adverse Events	8 weeks	Subjects reporting any treatment-emergent adverse events
Corneal Fluorescein Staining	8 weeks	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
Eye Dryness Score (7-Day Average)	8 weeks	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

Secondary Outcome Measures

Name	Time	Method
Conjunctival Lissamine Green Staining	8 weeks	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
Symptom Assessment in Dry Eye (SAnDE) Score Assessment	8 weeks	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
Tear Film Break-up Time (TBUT)	8 weeks	Mean change from baseline in TBUT in study eye
Ocular Discomfort Score by Visual Analog Scale	8 weeks	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
Conjunctival Hyperemia Grading	8 weeks	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
Schirmer's Test	8 weeks	Mean change from baseline in tear volume in study eye as assessed by unanesthetized Schirmer test

Trial Locations

Locations (1)

Allysta Pharmaceuticals; 🇺🇸 Bellevue, Washington, United States