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TTHX1114 Dose Level 1 for Corneal Epithelial Degeneration (EPI Trial)

Phase 1
Waitlist Available
Research Sponsored by Trefoil Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

EPI Trial Summary

This trial will gradually increase the dose to find the best and safest amount to take.

EPI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity

Side effects data

From 2015 Phase 4 trial • 157 Patients • NCT02003391
6%
Ocular hyperaemia
5%
Eye pruritus
2%
Nasopharyngitis
2%
Dry eye
1%
Acute tonsillitis
1%
Pharyngitis
1%
Conjunctivitis allergic
1%
Eyelids pruritus
1%
Blepharal pigmentation
1%
Eye irritation
1%
Cataract
1%
Arthritis
1%
Hypersensitivity
1%
Eye pain
1%
Ocular surface disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
DuoTrav
Beta-blocker

EPI Trial Design

4Treatment groups
Experimental Treatment
Group I: TTHX1114 Dose Level 4Experimental Treatment1 Intervention
TTHX1114(NM141) Ophthalmic Solution (DL4): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days
Group II: TTHX1114 Dose Level 3Experimental Treatment1 Intervention
TTHX1114(NM141) Ophthalmic Solution (DL3): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days
Group III: TTHX1114 Dose Level 2Experimental Treatment1 Intervention
TTHX1114(NM141) Ophthalmic Solution (DL2): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days
Group IV: TTHX1114 Dose Level 1Experimental Treatment1 Intervention
TTHX1114(NM141) Ophthalmic Solution (DL1): 1 drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TTHX1114(NM141) Ophthalmic Solution
2022
Completed Phase 1
~10

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Trefoil Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
112 Total Patients Enrolled
Thomas TremblayStudy DirectorTrefoil Therapeutics.com
2 Previous Clinical Trials
90 Total Patients Enrolled
~3 spots leftby Jun 2025
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