Allergic ConjunctivitisPhase 2NCT06293820
A Study Of TL-925 For The Treatment of AC
A Phase 2 study testing TL-925 in people with Allergic Conjunctivitis, run by Telios Pharma, Inc. at 1 site in United States.
Trial summary
In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 70 eligible subjects will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- TL-925
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2024to 21 May 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
- Individuals aged 18 years or older
- Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study.
- Documented history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the past 60 months.
- Calculated best-corrected visual activity of 0.7 LogMAR or better
- Positive bilateral CAC reaction
Who cannot join
- Any systemic or ocular disease currently producing ocular redness and/or ocular discomfort, or that may interfere with the conduct of the study.
- Any ocular surgical intervention within the last 3 months OR refractive surgery within the last 6 months
- Any ongoing ocular infection (bacterial, viral or fungal)
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: A Single Center, Randomized, Double-masked, Vehicle-controlled Phase 2b Study Evaluating the Safety and Efficacy of TL-925 Ophthalmic Emulsion 0.1% Compared to Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora CAC®) Model
In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 70 eligible subjects will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally.
The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis.
- Conditions
- Allergic Conjunctivitis
- Being tested
- TL-925, Placebo
- Medical subject headings
- Conjunctivitis, Allergic
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 | Subjects will be dosed in clinic and at home. Receives: Drug: TL-925 |
| Placebo Arm | Placebo comparator | Subjects will be dosed in clinic and at home. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Itching
Ocular itching score will be reported by the subject at 3 timepoints after CAC at Visits 4, 5 and 6. Assessments were reported using a 0-4 numerical scale (0 = none and 4 = incapacitating itch with an irresistible urge to rub).
Measured: 3, 5 and 7 minutes after CAC
Conjunctival Redness
Conjunctival redness score evaluated by the investigator at 3 timepoints after CAC at Visits 4, 5 and 6. Assessments were completed using a 0-4 numerical scale (0 = none and 4 = extremely severe).
Measured: 7, 15 and 20 minutes after CAC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start11 Apr 2024
- Primary completion21 May 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ConjunctivitisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 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
- NCT06293820
- Sponsor's protocol ID
- TL-925-304
- Status last verified
- Jul 2024
- First submitted
- 27 Feb 2024
- Last updated
- 3 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double-masked, Vehicle-controlled Phase 2b Study Evaluating the Safety and Efficacy of TL-925 Ophthalmic Emulsion 0.1% Compared to Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora CAC®) Model
- ClinicalTrials.gov ID
- NCT06293820
- Acronym / sponsor ID
- TL-925-304
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Telios Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 5 Mar 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 2, randomized, double-masked, vehicle controlled study, approximately 70 eligible subjects will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally.
The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TL-925 Arm | Active comparator | Drug: TL-925Subjects will be dosed in clinic and at home. |
| Placebo Arm | Placebo comparator | Drug: PlaceboSubjects will be dosed in clinic and at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals aged 18 years or older
- Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study.
- Documented history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the past 60 months.
- Calculated best-corrected visual activity of 0.7 LogMAR or better
- Positive bilateral CAC reaction
Key exclusion criteria (3 listed)
- Any systemic or ocular disease currently producing ocular redness and/or ocular discomfort, or that may interfere with the conduct of the study.
- Any ocular surgical intervention within the last 3 months OR refractive surgery within the last 6 months
- Any ongoing ocular infection (bacterial, viral or fungal)
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
Ocular Itching
Time frame: 3, 5 and 7 minutes after CAC
Ocular itching score will be reported by the subject at 3 timepoints after CAC at Visits 4, 5 and 6. Assessments were reported using a 0-4 numerical scale (0 = none and 4 = incapacitating itch with an irresistible urge to rub).
Conjunctival Redness
Time frame: 7, 15 and 20 minutes after CAC
Conjunctival redness score evaluated by the investigator at 3 timepoints after CAC at Visits 4, 5 and 6. Assessments were completed using a 0-4 numerical scale (0 = none and 4 = extremely severe).
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 3 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.
1 site 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 Allergic Conjunctivitis, run by Telios Pharma, Inc. at 1 site 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 5 inclusion and 3 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 3 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 1 site 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?
Ocular Itching (time frame: 3, 5 and 7 minutes after CAC). The study lists 2 primary outcomes in all. 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 3 Jul 2024.