OASIS-1: ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

Sponsor

Allysta Pharmaceutical (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04899518

Collaborator

(none)

900

Enrollment

Location

Arms

9.4

Anticipated Duration (Months)

95.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with Dry Eye Disease

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: ALY688 Ophthalmic Solution	Phase 2/Phase 3

Detailed Description

Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with Dry Eye Disease

Study Design

Study Type:

Interventional

Anticipated Enrollment :

900 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 2b/3, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease (OASIS-1)

Actual Study Start Date :

May 19, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Vehicle Ophthalmic Solution	Drug: ALY688 Ophthalmic Solution Ophthalmic Solution
Experimental: ALY688 Ophthalmic Solution Concentration 1	Drug: ALY688 Ophthalmic Solution Ophthalmic Solution
Experimental: ALY688 Ophthalmic Solution Concentration 2	Drug: ALY688 Ophthalmic Solution Ophthalmic Solution

Arm

Intervention/Treatment

Placebo Comparator: Vehicle Ophthalmic Solution

Drug: ALY688 Ophthalmic Solution

Ophthalmic Solution

Experimental: ALY688 Ophthalmic Solution Concentration 1

Drug: ALY688 Ophthalmic Solution

Ophthalmic Solution

Experimental: ALY688 Ophthalmic Solution Concentration 2

Drug: ALY688 Ophthalmic Solution

Ophthalmic Solution

Outcome Measures

Primary Outcome Measures

Corneal fluorescein staining [8 weeks]
Difference between ALY688 Ophthalmic Solution 0.4% and vehicle

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Dry eye disease for > 3 months meeting specific sign and symptom criteria
Best corrected 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 infection 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allysta Pharmaceuticals	Bellevue	Washington	United States	98004

Sponsors and Collaborators

Allysta Pharmaceutical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Allysta Pharmaceutical

ClinicalTrials.gov Identifier:

NCT04899518

Other Study ID Numbers:

ALY688-301

First Posted:

May 24, 2021

Last Update Posted:

Jun 25, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Eye Diseases

Ophthalmic Solutions

Study Results

No Results Posted as of Jun 25, 2021