Dry Eye DiseasePhase 2NCT06225973
A Study of TL-925 Ophthalmic Emulsion as a Treatment for Dry Eye Disease
A Phase 2 study testing TL-925 in people with Dry Eye Disease, run by Telios Pharma, Inc. at 18 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- TL-925
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 880 participants
- Where
- 18 sitesUnited States
- Study dates
- 6 Feb 2024to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Andover Eye Associates - Andover
Andover, Massachusetts, 01810
Pankratz Eye
Columbus, Indiana, 47203
Scott and Christie EyeCare Associates
Cranberry Township, Pennsylvania, 16066
Oculus Research
Garner, North Carolina, 27529
Global Research Management
Glendale, California, 91204
Advancing Vision Research
Goodlettsville, Tennessee, 37072
Nvision - La Mesa
La Mesa, California, 91942
Wilmington Eye
Leland, North Carolina, 28451
Butchertown Clinical
Louisville, Kentucky, 40206
Piedmont Eye Center
Lynchburg, Virginia, 24502
Total Eye Care, PA
Memphis, Tennessee, 38119
Wyse Eyecare
Northbrook, Illinois, 60062
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, 85032
Andover Eye Associates - Raynham
Raynham, Massachusetts, 02767
Advancing Vision Research
Smyrna, Tennessee, 37167
Nvision - Torrance
Torrance, California, 90505
NEERA - Westborough
Westborough, Massachusetts, 01581
NEERA - Woburn
Woburn, Massachusetts, 01801
About this study
Official title: A Phase 2b, Multicenter, Randomized, Double-masked Vehicle-controlled Study to Evaluate the Efficacy and Safety of TL-925 Ophthalmic Emulsion 0.1% in Subjects With Moderate to Severe Dry Eye Disease
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.
- Conditions
- Dry Eye Disease
- Being tested
- TL-925, Placebo
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TL-925Drug
TL-925 is an eye drop.
PlaceboOther
The composition of the vehicle is identical to the active formulation except for the exclusion of the active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| TL-925 Arm | Experimental | TL-925 will be administered OU BID Receives: Drug: TL-925 |
| Vehicle Arm | Placebo comparator | Vehicle will be administered OU BID Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of TL-925 compared to vehicle on tear production
Percentage of subjects who achieve ≥10 mm improvement in Schirmer's test score
Measured: Baseline to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start6 Feb 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telios Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225973
- Sponsor's protocol ID
- TL-925-303
- Status last verified
- Jul 2024
- First submitted
- 17 Jan 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Multicenter, Randomized, Double-masked Vehicle-controlled Study to Evaluate the Efficacy and Safety of TL-925 Ophthalmic Emulsion 0.1% in Subjects With Moderate to Severe Dry Eye Disease
- ClinicalTrials.gov ID
- NCT06225973
- Acronym / sponsor ID
- TL-925-303
- Conditions
- Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Telios Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TL-925 Arm | Experimental | Drug: TL-925TL-925 will be administered OU BID |
| Vehicle Arm | Placebo comparator | Other: PlaceboVehicle will be administered OU BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TL-925TL-925 is an eye drop. | Drug | TL-925 Arm |
| PlaceboThe composition of the vehicle is identical to the active formulation except for the exclusion of the active ingredient. | Other | Vehicle Arm |
Primary outcome
To evaluate the efficacy of TL-925 compared to vehicle on tear production
Time frame: Baseline to Day 29
Percentage of subjects who achieve ≥10 mm improvement in Schirmer's test score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TL-925 in people with Dry Eye Disease, run by Telios Pharma, Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of TL-925 compared to vehicle on tear production (time frame: Baseline to Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.