A Safety and Efficacy Trial of TTHX1114 in People With CED

(OPTIC Trial)

Recruiting at 3 trial locations

Overseen By Thomas Tremblay

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Trefoil Therapeutics, Inc.

Must not be taking: Interfering medications

Disqualifiers: Ocular cancer, Herpetic keratitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

41 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing TTHX1114, a new treatment for patients with Corneal Endothelial Dystrophy (CED). The goal is to see if it can help improve their eye condition. All participants will receive the treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that you cannot use any medications that might interfere with the study's safety and efficacy assessments. It's best to discuss your current medications with the study team to see if they are allowed.

Research Team

Thomas Tremblay

Principal Investigator

Trefoil Therapeutics.com

Eligibility Criteria

Inclusion Criteria

You are a woman of childbearing potential (WOCBP).

Proposed Study Eye that has been diagnosed with an ocular condition that, in the opinion of the Investigator, could possibly benefit from TTHX1114 administration, and has a measurable efficacy endpoint

No concurrent ocular or medical condition that would impair the assessment of safety and efficacy

Exclusion Criteria

You have a condition called uveitis.

You have had eye cancer in the past (including melanoma).

Documented and repeated elevated IOP in either eye

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TTHX1114 via intra-cameral injection weekly for 5 weeks

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TTHX1114

Participant Groups

Group I: TTHX1114 weekly x 5 Experimental Treatment 1 Intervention

TTHX1114 via IC injection weekly x 5

Who Is Running the Clinical Trial?

Trefoil Therapeutics, Inc.

Lead Sponsor

Trials

4

Recruited

120+