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Nonsteroidal Anti-inflammatory Drug (NSAID)

Test Eye for Congenital Hereditary Endothelial Dystrophy

Phase 2
Waitlist Available
Led By Neet Y Mehta, MBBS
Research Sponsored by L.V. Prasad Eye Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at each monthly follow-up till study completion, average 2 years
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved

Summary

CHED- Congenital Endothelial Endothelial Dystrophy is a condition that causes corneal cloudiness. Since, currently only surgery is being done to cure this condition, we are taking up the research of using topical eye drops for this condition which is a very simple and easy method. Also, there are no significant side effects to this treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at each monthly follow-up till study completion, average 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at each monthly follow-up till study completion, average 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the corneal transparency on Densitometry in the patients with CHED
Clinical change in the corneal transparency in the patients with CHED
Secondary study objectives
Change in the Corneal thickness
Change in visual acuity in patients of CHED

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Test EyeExperimental Treatment1 Intervention
These eyes will be given the Test drug, that is Nepafenac Eye Drops 0.1% w/v, at the dosage of 4 drops to be instilled in the eye 1 drop 4 times a day (every 4 hourly).That is at morning, afternoon, evening and at night. This is to be continued for a 6 months duration.
Group II: Control EyePlacebo Group1 Intervention
These eyes will be given the placebo, that is Carboxy-methylcellulose sodium lubricant eye drops 0.5%w/v, at the same dosage of 4 drops to be instilled in the eye 1 drop 4 times a day (every 4 hourly).That is at morning, afternoon, evening and at night. This is to be continued for a 6 months duration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nepafenac
FDA approved

Find a Location

Who is running the clinical trial?

L.V. Prasad Eye InstituteLead Sponsor
18 Previous Clinical Trials
4,825 Total Patients Enrolled
AllerganIndustry Sponsor
781 Previous Clinical Trials
276,624 Total Patients Enrolled
Neet Y Mehta, MBBSPrincipal InvestigatorL.V. Prasad Eye Institute
~6 spots leftby Oct 2025
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