ClinicalTrials.gg
CompletedNCT06293820Updated Jul 3, 2024

A Study Of TL-925 For The Treatment of AC

A Phase 2 interventional study of TL-925 and Placebo in Allergic Conjunctivitis, sponsored by Telios Pharma, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Telios Pharma, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2024, 2 years 5 months ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Allergic Conjunctivitis
03

In context

Conjunctivitis, Allergic

210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.

This study's enrollment of 80 is close to the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.

Browse Conjunctivitis, Allergic studies →

Lead sponsor

Telios Pharma, Inc. is the lead sponsor of 11 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals aged 18 years or older
  • Female subjects of and their male partners must both use a highly effective 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

Exclusion criteria

Exclusion Criteria:

  • 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    TL-925 Arm

    Subjects will be dosed in clinic and at home.

    Drug: TL-925

  • Placebo comparator
    Placebo Arm

    Subjects will be dosed in clinic and at home.

    Drug: Placebo

Interventions

  • DrugTL-925

    TL-925 is an eye drop.

  • DrugPlacebo

    The composition of the placebo is identical to the active formulation except for the exclusion of the active ingredient.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 3, 5 and 7 minutes after CAC

  2. 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).

    Time frame: 7, 15 and 20 minutes after CAC

07

Study locations

1 site
  • Andover Eye Associates
    Andover, Massachusetts 01810, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2024 to primary completion in May 2024, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2024
First posted
Mar 5, 2024
StartActual
Apr 11, 2024
Primary completionActual
May 21, 2024
CompletionActual
May 21, 2024
Last update
Jul 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06293820
Lead sponsor
Telios Pharma, Inc.
Responsible party
Sponsor
First posted
Mar 5, 2024
Start date
Apr 11, 2024
Primary completion
May 21, 2024
Completion
May 21, 2024
Last update
Jul 3, 2024

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: TL-925

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