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

Telios Pharma

Status and phase: Active, not recruiting; Phase 2

Conditions: Dry Eye Disease

Treatments: Drug: TL-925; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06225973

TL-925-303

Details and patient eligibility

About

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.

Enrollment: 880 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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880 participants in 2 patient groups, including a placebo group

TL-925 Arm

Experimental group

Description:

TL-925 will be administered OU BID

Treatment:

Drug: TL-925

Vehicle Arm

Placebo Comparator group

Description:

Vehicle will be administered OU BID

Treatment:

Other: Placebo