Back to resultsA Study of TL-925 as a Treatment for Dry Eye Disease
Primary Purpose
Dry Eye Disease
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TL-925
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease focused on measuring TL-925, Phase II
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
Sites / Locations
- Aesthetic Eye Care
- Vision Institute
- Michael Washburn Center for Ophthalmic Research, LLC.
- Andover Eye Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
TL-925 Arm
Placebo Arm
Arm Description
For the first 7 days subjects will administer 1 drop of TL-925 followed by a 5 minute wait before administering a second drop to each eye during each dosing session. For days 8-28, subjects will administer 1 drop TL-925 OU BID.
For the first 7 days subjects will administer 1 drop of placebo followed by a 5 minute wait before administering a second drop to each eye during each dosing session. For days 8-28, subjects will administer 1 drop placebo OU BID.
Outcomes
Primary Outcome Measures
Adverse events during screening & treatment period
Secondary Outcome Measures
Change from baseline in corneal and conjunctival staining
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
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
Best corrected visual acuity (BCVA) will be used to determine change in visual acuity from baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05745064
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
July 18, 2023 (Anticipated)
Study Completion Date
July 18, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Telios Pharma, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
Keywords
TL-925, Phase II
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TL-925 Arm
Arm Type
Active Comparator
Arm Description
For the first 7 days subjects will administer 1 drop of TL-925 followed by a 5 minute wait before administering a second drop to each eye during each dosing session. For days 8-28, subjects will administer 1 drop TL-925 OU BID.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
For the first 7 days subjects will administer 1 drop of placebo followed by a 5 minute wait before administering a second drop to each eye during each dosing session. For days 8-28, subjects will administer 1 drop placebo OU BID.
Intervention Type
Drug
Intervention Name(s)
TL-925
Intervention Description
TL-925 is an oil-in-water emulsion containing the active pharmaceutical ingredient at a concentration of 0.1%.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The composition of the placebo is identical to the active formulation, except for the inclusion of the active ingredient.
Primary Outcome Measure Information:
Title
Adverse events during screening & treatment period
Time Frame
Baseline to the end of day 29 (±2 days)
Secondary Outcome Measure Information:
Title
Change from baseline in corneal and conjunctival staining
Description
Fluorescein staining by region in designated study eye will be used. Results will be assessed using a 5-point Corneal and Conjunctival Staining Scale.
Time Frame
Baseline to the end of day 29 (±2 days)
Title
Change from baseline in ocular discomfort
Description
Visual analog scale (VAS) will be used. This will assess patients on a a 7-item 100-point scale based on ocular discomfort.
Time Frame
Baseline to the end of day 29 (±2 days)
Title
Change from baseline visual acuity
Description
Best corrected visual acuity (BCVA) will be used to determine change in visual acuity from baseline.
Time Frame
Baseline to the end of day 29 (±2 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Aesthetic Eye Care
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Vision Institute
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Michael Washburn Center for Ophthalmic Research, LLC.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46240
Country
United States
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of TL-925 as a Treatment for Dry Eye Disease
We'll reach out to this number within 24 hrs