A Study of TL-925 as a Treatment for Dry Eye Disease | NCT05745064

Studies
A Study of TL-925 as a Treatment for Dry Eye Disease

NCT05745064

Sponsor

Telios Pharma, Inc.

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

107Actual

Phase

Phase 2

Conditions

Dry Eye Disease

Interventions

TL-925
Placebo

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

Nov 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

Feb 27, 2023Actual

Primary Completion Date

Jul 11, 2023Actual

Completion Date

Jul 11, 2023Actual

First Submitted Date

Feb 7, 2023

First Submission Date that Met QC Criteria

Feb 22, 2023

First Posted Date

Feb 27, 2023Actual

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

Nov 14, 2023

Last Update Posted Date

Nov 18, 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

In this prospective, Phase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, approximately 100 subjects with moderate to severe dry eye disease (DED) will be randomly assigned (1:1) to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally BID.

The study will comprise two phases: 2-weeks screening/run-in and 4-weeks double-masked treatment.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

107Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TL-925 Arm	Active Comparator	TL-925 will be administered OU BID	Drug: TL-925
Placebo Arm	Placebo Comparator	Placebo will be administered OU BID	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TL-925	Drug	TL-925 is an eye drop.	TL-925 Arm
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events during screening & treatment period		Baseline to the end of day 29 (±2 days)

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in corneal and conjunctival staining	Fluorescein staining by region in designated study eye will be used. Results will be assessed using a 5-point Corneal and Conjunctival Staining Scale.	Baseline to the end of day 29 (±2 days)
Change from baseline in ocular discomfort

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals aged 18 years or older
A diagnosis of dry eye disease for at least 6 months
An unanesthetized Schirmer's test score (STS) of ≤ 10mm and ≥ 1mm in the study eye
A tear film break-up time (TFBUT) of ≤ 5 seconds in the study eye
A corneal fluorescein staining score of ≥ 2 in at least one region of the cornea
A sum corneal fluorescein staining score of ≥ 4 in the study eye
A total lissamine green conjunctival score of ≥ 2 in the study eye
Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study.

Exclusion Criteria:

Any clinically significant slit lamp finding
Any ongoing ocular infection (bacterial, viral or fungal) or active ocular inflammation
Any keratorefractive surgery within the last 12 months
Any intraocular or extraocular surgery within 3 months

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
Aesthetic Eye Care		Newport Beach	California	92663	United States
Vision Institute

ID	Term
D015352	Dry Eye Syndromes

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Intervention Model Description

The study will comprise two phases: 2-weeks screening/run-in and 4-weeks double-masked treatment.

Masking Info

Masking

Quadruple

Masking Description

The Sponsor, Investigators and study staff will be masked during the randomization process and throughout the study. The study site will have the capacity to unmask participants in an emergency.

Following completion of the study, the randomization code will be unmasked once all data has been entered into the Study database for every subject and the database has been locked.

Who Masked

ParticipantCare ProviderInvestigatorOutcomes Assessor