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

T

Telios Pharma

Status and phase

Enrolling
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

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

Trial contacts and locations

18

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Central trial contact

John Mei; Yulia Khalina

Data sourced from clinicaltrials.gov

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