FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/06/034382 [Registered on: 25/06/2021] Trial Registered Prospectively
Last Modified On: 01/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Congenital Cloudy Cornea:New Therapy Using Topical Eye Drops 
Scientific Title of Study   Corneal Dystrophies Caused by SLC4A11 Mutation: A Promising New Paradigm Shift in Therapy Using an Ophthalmic Nonsteroidal Anti-Inflammatory Eye Drops 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NCT04843839  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Muralidhar Ramappa 
Designation  Consultant Pediatric Cornea and Anterior Segment services, LVPEI 
Affiliation  L V Prasad Eye Institute 
Address  Centre for rare eye disease and ocular genetics, Cornea institute & Jasti V Ramanamma Childrens Eye Care Centre, LV Prasad Eye Institute, LV Prasad Marg, Banjara Hills

Hyderabad
TELANGANA
500034
India 
Phone  4068102623  
Fax    
Email  muralidhar@lvpei.org  
 
Details of Contact Person
Scientific Query  
Name  Neet Mehta 
Designation  Resident, LV Prasad Eye Institute 
Affiliation  L V Prasad Eye Institute 
Address  Education Department, L V Prasad Eye Institute, Kallam Anji Reddy Campus, LV Prasad Marg, Banjara Hills, Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  9712002747  
Fax    
Email  mehta.neet28@gmail.com  
 
Details of Contact Person
Public Query  
Name  Neet Mehta 
Designation  Resident, LV Prasad Eye Institute 
Affiliation  L V Prasad Eye Institute 
Address  Education Department, L V Prasad Eye Institute, Kallam Anji Reddy Campus, LV Prasad Marg, Banjara Hills, Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  9712002747  
Fax    
Email  mehta.neet28@gmail.com  
 
Source of Monetary or Material Support  
ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED 
Hyderabad Eye Research Foundation 
 
Primary Sponsor  
Name  Hyderabad Eye Research Foundation 
Address  L V Prasad Eye Institute, Kallam Anji Reddy Campus, Banjara Hills, Road No. 2, Hyderabad-500034  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Muralidhar Ramappa  LV Prasad Eye Institute  Cornea Institute and Jasti V Ramanamma Childrens Eye Care Centre
Hyderabad
TELANGANA 		 4068102623

muralidhar@lvpei.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
LV Prasad Eye Institute Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Carboxy-methylcellulose sodium lubricant eye drops 0.5%w/v  Carboxy-methylcellulose sodium lubricant eye drops 0.5%w/v Dose- 1 drop QID for 6 months 
Intervention  Nepafenac 0.1% Ophthalmic Suspension  Nepafenac 0.1% eye drops Dosage- 1 drop QID for 6 months 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  9.00 Year(s)
Gender  Both 
Details  -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 
 
ExclusionCriteria 
Details  1. Patients undergone eye surgery (PK,DSEK,DMEK, Glaucoma surgery, etc)
2. Patient with eye pathologies like-glaucoma,dry eye,nystagmus,cataract,corneal ulcer,reduced corneal sensations,etc
3. Not able to come for follow up
4.Asymmetrical corneal involvement
5.Allergy to the drug
6. Patients with asthma or bleeding dyscrasias
7. Non-cooperative children

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Clinical change in the corneal transparency in the patients with CHED (slitlamp)
2.Change in the corneal transparency on Densitometry in the patients with CHED (Oculyzer machine) 		 Measured at each monthly follow-up till study completion 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in visual acuity in patients of CHED (Subjective Refraction)
2. Change in the Corneal thickness Pachymetry/ Anterior Segment OCT (Optical Coherence Tomography) readings at each visit 		 Measured at each monthly follow-up till study completion 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/07/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
CHED- Congenital Endothelial Endothelial Dystrophy is a condition that causes corneal cloudiness. Currently only surgery is being done to cure this condition. The purpose of this study is to explore the role of using topical eye drops for this condition which is a very simple and an easy method with no significant side effects.
 
Close