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

Telios Pharma

Status and phase: Completed; Phase 2

Conditions: Dry Eye Disease

Treatments: Drug: TL-925; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05745064

TL-925-301

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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107 participants in 2 patient groups, including a placebo group

TL-925 Arm

Active Comparator group

Description:

TL-925 will be administered OU BID

Treatment:

Drug: TL-925

Placebo Arm

Placebo Comparator group

Description:

Placebo will be administered OU BID

Treatment:

Drug: Placebo