CHED - Congenital Hereditary Endothelial Dystrophy: New Paradigm Shift in Therapy Using Topical Eye Drops

NCT04843839 | Unknown Phase 2

• 1 other identifier: LEC-BHR-P-10-20-526
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Hereditary Endothelial Dystrophy of Cornea

Keywords

CHED

Outcome Measures

Primary Outcomes (2)

• Clinical change in the corneal transparency in the patients with CHED

  Assessed by: Clinical grading of the corneal opacities at each visit as- Grade 0- no haze Grade 1-Iris details visible Grade 2-Pupil margin visible; iris details not visible Grade 3-Pupil margin not visible Grade 4-Cornea totally opaque

  Measured at each monthly follow-up till study completion, average 2 years

• Change in the corneal transparency on Densitometry in the patients with CHED

  Assessed by: Densitometry reading on Oculyzer machine

  Measured at each monthly follow-up till study completion, average 2 years

Secondary Outcomes (2)

• Change in visual acuity in patients of CHED

  Measured at each monthly follow-up till study completion, average 2 years

• Change in the Corneal thickness

  Measured at each monthly follow-up till study completion, average 2 years

Study Arms (2)

Test Eye

EXPERIMENTAL

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.

Drug: Nepafenac 0.1% Oph Susp

Control Eye

PLACEBO COMPARATOR

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.

Drug: Refresh Tears 0.5% Lubricant Eye Drops

Interventions

Nepafenac 0.1% Oph Susp DRUG

Nepafenac 0.1% eye drops - Allergan : Dosage- 1 drop QID for 6 months

Also known as: Amplinak

Test Eye

Refresh Tears 0.5% Lubricant Eye Drops DRUG

Refresh Tears 0.5% w/v eye drops - Allergan : Dose- 1 drop QID for 6 months

Also known as: Carboxy-methylcellulose sodium lubricant eye drops 0.5%w/v

Control Eye

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children upto 9 years of age diagnosed with CHED (Congenital Hereditary Endothelial Dystrophy) with bilaterally equal corneal involvement
• Patients agreeing on a regular monthly follow-up for a minimum of 6 months

You may not qualify if:

• Patient undergone any other surgery like Penetrating keratoplasty (PK), Descemet stripping automated endothelial keratoplasty (DSEK) and Descemet's membrane endothelial keratoplasty (DMEK), Glaucoma surgeries, in one of both eyes
• Patients with concomitant ophthalmic pathologies like glaucoma, poor corneal surface, dry eye disease, corneal ulcers, systemic inflammatory conditions, cataract, nystagmus, Reduced corneal sensation etc.
• Patients not able to come for follow-ups
• Asymmetrical corneal involvement
• Patients with known allergy to ophthalmic NSAID's
• Patients with asthma or bleeding dyscrasias
• Non-cooperative children

Sponsors & Collaborators

• L.V. Prasad Eye Institute: lead
• Allergan: collaborator

Study Sites (1)

L V Prasad Eye Institute

Hyderabad, Banjara Hills, 500034, India

RECRUITING

MeSH Terms

Conditions

Corneal Dystrophy, Posterior Polymorphous, 1

Interventions

nepafenac; Lubricant Eye Drops

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Officials

• Muralidhar Ramappa, MS

  L.V. Prasad Eye Institute

  PRINCIPAL INVESTIGATOR

• Neet Y Mehta, MBBS

  L.V. Prasad Eye Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neet Y Mehta, MBBS

CONTACT

9712002747; mehta.neet28@gmail.com

Muralidhar Ramappa, MS

CONTACT

muralidhar@lvpei.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Pediatric Cornea and Anterior Segment services, LVPEI

Model Details: Paired eye study- So one eye will be subjected to test drug, while the other eye will be subjected to a placebo

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 14, 2021
• Study Start: December 15, 2020
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: April 14, 2021

Record last verified: 2021-04

Locations

IN (1)