← Back to Search

Other

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
Female or male, 18 to 65 years of age
Body mass index 18.5 to 35 kg/m^2
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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are between 18 and 65 years of age, regardless of gender.
Select...
Your body mass index is between 18.5 and 35 kg/m^2.

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%
Blepharal pigmentation
1%
Pharyngitis
1%
Eye irritation
1%
Eyelids pruritus
1%
Cataract
1%
Conjunctivitis allergic
1%
Acute tonsillitis
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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals over 75 years old precluded from participating in this experiment?

"The entry requirements for this trial entail that participants must be 18 years old or older, yet not exceed 65."

Answered by AI

Are there any vacancies available for participants of this research project?

"This clinical trial, which was initially posted on December 6th 2022 is still recruiting patients. The information hosted on clinicaltrials.gov was last updated in March 3rd of 2023."

Answered by AI

Has TTHX1114 Dose Level 1 been certified by the FDA?

"Our team has assigned TTHX1114 Dose Level 1 a score of 1 because the clinical data available is restricted to Phase 1 trials, which lack sufficient evidence for safety and efficacy."

Answered by AI

Who qualifies for inclusion in this experiment?

"Patients with corneal epithelial degeneration aged 18-65 are eligible to apply for this clinical trial, which is seeking around 30 participants."

Answered by AI

What is the cap on enrollment for this clinical experiment?

"Affirmative, the clinicaltrials.gov page for this therapeutic trial confirms that it is actively recruiting participants. This study was initially announced on December 6th 2022 and updated as recently as March 3rd 2023. The research team requires 30 individuals to be recruited from a single medical centre."

Answered by AI
~4 spots leftby Mar 2025