Dry Eye Disease
Conditions
Keywords
TL-925, Phase II
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.
Interventions
DRUGTL-925
TL-925 is an eye drop.
DRUGPlacebo
The composition of the placebo is identical to the active formulation except for the exclusion of the active ingredient.
Sponsors
Telios Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events during screening & treatment period | Baseline to the end of day 29 (±2 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in corneal and conjunctival staining | 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. |
| Change from baseline in ocular discomfort | 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. |
| Change from baseline visual acuity | 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. |
Countries
United States
Outcome results
None listed