Dry Eye DiseasePhase 2NCT05745064
A Study of TL-925 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 4 sites in United States.
Trial 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. 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
- 107 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Feb 2023to 11 Jul 2023
- 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
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Vision Institute
Colorado Springs, Colorado, 80907
Michael Washburn Center for Ophthalmic Research, LLC.
Indianapolis, Indiana, 46240
Aesthetic Eye Care
Newport Beach, California, 92663
About this study
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
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.
- Conditions
- Dry Eye Disease
- Being tested
- TL-925, Placebo
- Keywords
- TL-925, Phase II
- 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.
PlaceboDrug
The composition of the placebo is identical to the active formulation except for the exclusion of the active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| TL-925 Arm | Active comparator | TL-925 will be administered OU BID Receives: Drug: TL-925 |
| Placebo Arm | Placebo comparator | Placebo will be administered OU BID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events during screening & treatment period
Measured: Baseline to the end of day 29 (±2 days)
Secondary outcomes (3)
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.
Measured: Baseline to the end of day 29 (±2 days)
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.
Measured: Baseline to the end of day 29 (±2 days)
Change from baseline visual acuity
Best corrected visual acuity (BCVA) will be used to determine change in visual acuity from baseline.
Measured: Baseline to the end of day 29 (±2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start27 Feb 2023
- Primary completion11 Jul 2023
- Study completion11 Jul 2023
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
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telios Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745064
- Sponsor's protocol ID
- TL-925-301
- Status last verified
- Nov 2023
- First submitted
- 7 Feb 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05745064
- Acronym / sponsor ID
- TL-925-301
- Conditions
- Dry Eye Disease
- Keywords
- TL-925, Phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Telios Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 11 Jul 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 27 Feb 2023 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| TL-925 Arm | Active comparator | Drug: TL-925TL-925 will be administered OU BID |
| Placebo Arm | Placebo comparator | Drug: PlaceboPlacebo 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 (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 placebo is identical to the active formulation except for the exclusion of the active ingredient. | Drug | Placebo Arm |
Primary outcome
Adverse events during screening & treatment period
Time frame: Baseline to the end of day 29 (±2 days)
3 secondary outcomes
Change from baseline in corneal and conjunctival staining
Time frame: Baseline to the end of day 29 (±2 days)
Change from baseline in ocular discomfort
Time frame: Baseline to the end of day 29 (±2 days)
Change from baseline visual acuity
Time frame: Baseline to the end of day 29 (±2 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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.
4 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 4 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 8 inclusion and 4 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: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse events during screening & treatment period (time frame: Baseline to the end of day 29 (±2 days)). 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 18 Nov 2023.