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

NCT06225973 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: TL-925-303
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 18

Brief Summary

In this prospective, phase 2b, multicenter, randomized, double-masked, vehicle-controlled, parallel-arm study, approximately 880 subjects with moderate to severe dry eye disease (DED) will be randomly assigned (1:1) to receive either TL-925 or vehicle as topical ophthalmic eye drops administered bilaterally BID. The study will comprise two phases: a two-week screening phase/run-in and a six-week double-masked treatment phase.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of TL-925 compared to vehicle on tear production

  Percentage of subjects who achieve ≥10 mm improvement in Schirmer's test score

  Baseline to Day 29

Study Arms (2)

TL-925 Arm

EXPERIMENTAL

TL-925 will be administered OU BID

Drug: TL-925

Vehicle Arm

PLACEBO COMPARATOR

Vehicle will be administered OU BID

Other: Placebo

Interventions

TL-925 DRUG

TL-925 is an eye drop.

TL-925 Arm

Placebo OTHER

The composition of the vehicle is identical to the active formulation except for the exclusion of the active ingredient.

Vehicle Arm

Eligibility Criteria

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

You may qualify if:

• 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
• Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study

You may not qualify if:

• Any clinically significant slit lamp finding
• Any ongoing ocular infection (bacterial, viral or fungal) or active ocular inflammation
• Best-corrected visual acuity ≥0.7 logarithm of the minimum angle of resolution
• Any keratorefractive surgery within the last 12 months
• Any intraocular or extraocular surgery within 3 months
• Any blepharoplasty or corneal transplant in either eye
• Any form of punctual, or intracanalicular occlusion in either eye
• History or presence of any ocular disorder that may interfere with study results

Sponsors & Collaborators

• Telios Pharma, Inc.: lead

Study Sites (18)

Cornea and Cataract Consultants of Arizona

Phoenix, Arizona, 85032, United States

Location

Global Research Management

Glendale, California, 91204, United States

Location

Nvision - La Mesa

La Mesa, California, 91942, United States

Location

Nvision - Torrance

Torrance, California, 90505, United States

Location

Wyse Eyecare

Northbrook, Illinois, 60062, United States

Location

Pankratz Eye

Columbus, Indiana, 47203, United States

Location

Butchertown Clinical

Louisville, Kentucky, 40206, United States

Location

Andover Eye Associates - Andover

Andover, Massachusetts, 01810, United States

Location

Andover Eye Associates - Raynham

Raynham, Massachusetts, 02767, United States

Location

NEERA - Westborough

Westborough, Massachusetts, 01581, United States

Location

NEERA - Woburn

Woburn, Massachusetts, 01801, United States

Location

Oculus Research

Garner, North Carolina, 27529, United States

Location

Wilmington Eye

Leland, North Carolina, 28451, United States

Location

Scott and Christie EyeCare Associates

Cranberry Township, Pennsylvania, 16066, United States

Location

Advancing Vision Research

Goodlettsville, Tennessee, 37072, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

Advancing Vision Research

Smyrna, Tennessee, 37167, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: February 6, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

US (18)