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

NCT04201574 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ALY688-201
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Ocular Discomfort Score by Visual Analog Scale

  8 weeks

• Symptom Assessment in Dry Eye (SAnDE) Score Assessment

  8 weeks

• Conjunctival Lissamine Green Staining

  8 weeks

• Conjunctival Hyperemia Grading

  8 weeks

• Tear Film Break-up Time (TBUT)

  8 weeks

Study Arms (3)

Vehicle

PLACEBO COMPARATOR

Vehicle Ophthalmic Solution

Drug: Vehicle

ALY688 0.1%

EXPERIMENTAL

ALY688 0.1% Ophthalmic Solution

Drug: ALY688 0.1%

ALY688 0.4%

EXPERIMENTAL

ALY688 0.4%Ophthalmic Solution

Drug: ALY688 0.4%

Interventions

ALY688 0.1% DRUG

ALY688 0.1% Ophthalmic Solution

Also known as: ALY688 Ophthalmic

ALY688 0.1%

ALY688 0.4% DRUG

ALY688 0.4% Ophthalmic Solution

Also known as: ALY688 Ophthalmic

ALY688 0.4%

Vehicle DRUG

Vehicle Ophthalmic Solution

Also known as: placebo

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allysta Pharmaceutical: lead

Study Sites (1)

Allysta Pharmaceuticals

Bellevue, Washington, 98006, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Clinical Trial Admin
• Organization: Allysta Pharmaceuticals, Inc.

clinicaltrial.admin@allysta.com

(510) 560-6592

Study Officials

• Henry Hsu, MD

  Allysta Pharmaceutical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 17, 2019
• Study Start: December 16, 2019
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)