ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease | NCT04899518

Studies
ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease

NCT04899518

Sponsor

Allysta Pharmaceutical

Status

Completed

Last Update Posted

Mar 16, 2023Actual

Enrollment

922Actual

Phase

Phase 2Phase 3

Conditions

Dry Eye

Interventions

ALY688 Ophthalmic Solution

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 19, 2021Actual

Primary Completion Date

Mar 14, 2023Actual

Completion Date

Mar 14, 2023Actual

First Submitted Date

May 19, 2021

First Submission Date that Met QC Criteria

May 19, 2021

First Posted Date

May 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2023

Last Update Posted Date

Mar 16, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

922Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Vehicle Ophthalmic Solution	Placebo Comparator	Drug: ALY688 Ophthalmic Solution
ALY688 Ophthalmic Solution Concentration 1	Experimental	Drug: ALY688 Ophthalmic Solution
ALY688 Ophthalmic Solution Concentration 2	Experimental	Drug: ALY688 Ophthalmic Solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALY688 Ophthalmic Solution	Drug	Ophthalmic Solution	ALY688 Ophthalmic Solution Concentration 1 ALY688 Ophthalmic Solution Concentration 2 Vehicle Ophthalmic Solution

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Corneal fluorescein staining	Difference between ALY688 Ophthalmic Solution 0.4% and vehicle	8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Allysta Pharmaceuticals		Bellevue	Washington	98004	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Submission Tracking

Estimated Results First Submitted Date

Aug 27, 2024

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 27, 2024			Sep 16, 2024	5

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided