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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-27

Study Completion Date

2023-07-11

Brief Summary

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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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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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TL-925 Arm

TL-925 will be administered OU BID

Group Type ACTIVE_COMPARATOR

TL-925

Intervention Type DRUG

TL-925 is an eye drop.

Placebo Arm

Placebo will be administered OU BID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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TL-925

TL-925 is an eye drop.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No