A Phase 2 interventional study of TL-925 and Placebo in Allergic Conjunctivitis, sponsored by Telios Pharma, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-01.
Sponsored by Telios Pharma, Inc. · Phase 2, Interventional, and Treatment
In this prospective Phase 2, single-center, randomized, double-masked, placebo-controlled study, approximately 70 subjects with allergic conjunctivitis 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.
210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.
This study's planned enrollment of 70 is below the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.
Browse Conjunctivitis, Allergic studies →Telios Pharma, Inc. is the lead sponsor of 11 studies on the registry; 5 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be dosed in clinic on days of dosing.
Drug: TL-925
Subjects will be dosed in clinic on days of dosing.
Drug: Placebo
TL-925 is an eye drop.
The composition of the placebo is identical to the active formulation except for the exclusion of the active ingredient.
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
Conjunctival redness
Conjunctival redness will be assessed 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
Start is estimated for Nov 2023; primary completion for Jan 2024, 2 months later.
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Studies of the drug tested here: TL-925
Telios Pharma, Inc.