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

NCT05745064 | Completed Phase 2 FDA Drug

• 1 other identifier: TL-925-301
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 4

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.

Conditions

Dry Eye Disease

Keywords

TL-925; Phase II

Outcome Measures

Primary Outcomes (1)

• Adverse events during screening & treatment period

  Baseline to the end of day 29 (±2 days)

Secondary Outcomes (3)

• Change from baseline in corneal and conjunctival staining

  Baseline to the end of day 29 (±2 days)

• Change from baseline in ocular discomfort

  Baseline to the end of day 29 (±2 days)

• Change from baseline visual acuity

  Baseline to the end of day 29 (±2 days)

Study Arms (2)

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

TL-925 DRUG

TL-925 is an eye drop.

TL-925 Arm

Placebo DRUG

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

Placebo Arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Telios Pharma, Inc.: lead

Study Sites (4)

Aesthetic Eye Care

Newport Beach, California, 92663, United States

Location

Vision Institute

Colorado Springs, Colorado, 80907, United States

Location

Michael Washburn Center for Ophthalmic Research, LLC.

Indianapolis, Indiana, 46240, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• 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

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 27, 2023
• Study Start: February 27, 2023
• Primary Completion: July 11, 2023
• Study Completion: July 11, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (4)