Clinical trial NCT05745064: A Study of TL-925 as a Treatment for Dry Eye Disease
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease
Keywords: TL-925
Phase II
Lead sponsor: Telios Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-27
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse events during screening & treatment period
timeFrame: Baseline to the end of day 29 (±2 days)
Secondary outcomes:
measure: Change from baseline in corneal and conjunctival staining
timeFrame: Baseline to the end of day 29 (±2 days)
measure: Change from baseline in ocular discomfort
timeFrame: Baseline to the end of day 29 (±2 days)
measure: Change from baseline visual acuity
timeFrame: Baseline to the end of day 29 (±2 days)
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Aesthetic Eye Care
state: California
city: Colorado Springs
country: United States
facility: Vision Institute
state: Colorado
city: Indianapolis
country: United States
facility: Michael Washburn Center for Ophthalmic Research, LLC.
state: Indiana
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References: