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

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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: Vehicle; Drug: ALY688 0.1%; Drug: ALY688 0.4%

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 Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Bellevue, Washington, United States, 98006
      • Allysta Pharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle; Vehicle Ophthalmic Solution	Drug: Vehicle; Vehicle Ophthalmic Solution; Other Names: placebo
Experimental: ALY688 0.1%; ALY688 0.1% Ophthalmic Solution	Drug: ALY688 0.1%; ALY688 0.1% Ophthalmic Solution; Other Names: ALY688 Ophthalmic
Experimental: ALY688 0.4%; ALY688 0.4%Ophthalmic Solution	Drug: ALY688 0.4%; ALY688 0.4% Ophthalmic Solution; Other Names: ALY688 Ophthalmic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Adverse Events	Subjects reporting any treatment-emergent adverse events	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	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	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Tear Film Break-up Time (TBUT)	Mean change from baseline in TBUT in study eye	8 weeks
Schirmer's Test	Mean change from baseline in tear volume in study eye as assessed by unanesthetized Schirmer test	8 weeks

Collaborators and Investigators

• Sponsor: Allysta Pharmaceutical
• Investigators: Study Director: Henry Hsu, MD, Allysta Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): September 15, 2020

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: ALY688-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No