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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04201574
• Other study ID #: ALY688-201
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 16, 2019
• Est. completion date: September 15, 2020

Study information

• Verified date: May 2023
• Source: Allysta Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• ALY688 0.1%
ALY688 0.1% Ophthalmic Solution
• ALY688 0.4%
ALY688 0.4% Ophthalmic Solution
• Vehicle
Vehicle Ophthalmic Solution

Locations

Country	Name	City	State
United States	Allysta Pharmaceuticals	Bellevue	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Allysta Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome

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