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OpenTrials
Completed

NCT Number: NCT05745064

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

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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aesthetic Eye Care, Newport Beach, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TL-925

Drug

TL-925 is an eye drop.

Placebo

Drug

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

Primary outcomes

  1. Adverse events during screening & treatment period

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

Secondary outcomes

  1. Change from baseline in corneal and conjunctival staining

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

    Fluorescein staining by region in designated study eye will be used. Results will be assessed using a 5-point Corneal and Conjunctival Staining Scale.

  2. Change from baseline in ocular discomfort

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

    Visual analog scale (VAS) will be used. This will assess patients on a a 7-item 100-point scale based on ocular discomfort.

  3. Change from baseline visual acuity

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

    Best corrected visual acuity (BCVA) will be used to determine change in visual acuity from baseline.

Sponsors and collaborators

Lead sponsor

Telios Pharma, Inc.

Industry

Registry information

Official study title

A Phase 2, Multicenter, Randomized, Double-masked, Placebo-controlled Study to Evaluate the Safety and Tolerability of TL-925 Ophthalmic Emulsion 0.1% in Subjects With Moderate to Severe Dry Eye Disease

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 27, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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