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CTRI Number  CTRI/2024/03/063972 [Registered on: 11/03/2024] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Lubricating eye ointment, eye taping and their combination in preventing exposure keratopathy 
Scientific Title of Study   A comparative study of efficacy of prophylactic use of lubricating eye ointment, eye taping and their combination in preventing exposure keratopathy in critically ill patients: A pilot study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Keerti Wali 
Designation  Assistant professor 
Affiliation  Shri B.M. Patil Medical College, Vijayapura, Karnataka 
Address  Department of Ophthalmology, Shri B.M. Patil Medical College, Vijayapura, Karnataka

Bijapur
KARNATAKA
586103
India 
Phone  8376934338  
Fax    
Email  keertignec14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Keerti Wali 
Designation  Assistant Professor 
Affiliation  Shri B.M. Patil Medical College, Vijayapura, Karnataka 
Address  Department of Ophthalmology, Shri B.M. Patil Medical College, Vijayapura, Karnataka

Bijapur
KARNATAKA
586103
India 
Phone  8376934338  
Fax    
Email  keertignec14@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Keerti Wali 
Designation  Assistant professor 
Affiliation  Shri B.M. Patil Medical College, Vijayapura, Karnataka 
Address  Department of Ophthalmology, Shri B.M. Patil Medical College, Vijayapura, Karnataka

Bijapur
KARNATAKA
586103
India 
Phone  8376934338  
Fax    
Email  keertignec14@gmail.com  
 
Source of Monetary or Material Support  
Applied grant at B.L.D.E. University  
 
Primary Sponsor  
Name  BLDE University 
Address  Bangaramma Sajjan Campus, Solapur road, Vijayapura, Karnataka. Pin:586103  
Type of Sponsor  Other [Deemed to be University] 
 
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 
Dr Keerti Wali  Shri B.M. Patil Medical College, Vijayapura, Karnataka  Room no 13, Department of Ophthalmology, Shri B.M. Patil Medical College, Vijayapura, Karnataka
Bijapur
KARNATAKA 		 8376934338

keertignec14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee of BLDE University   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H188||Other specified disorders of cornea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Both  Both eyelid taping will be done and eye ointment will be applied 
Intervention  Eye ointment  2% hydroxypropyl methylcellulose eye ointment is to be used every six hours. About 2 cm of ointment would be applied in the inferior fornix of the eye using a sterile technique; Both will be applied 
Intervention  Eyelid taping  Eyelid would be closed every six hours by a piece of tape 1.25 cm in width. A break of 15 minutes will be given during every change of tape 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients above 18 years of age admitted in critical care unit with impaired blink reflex. 
 
ExclusionCriteria 
Details  1. History of ophthalmic disease or eye surgery
2. History of injury preventing the eyelids from closing.
3. Previous ICU admissions in the past month.
4. Patients positive for the fluorescein test
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Grading of corneal exposure status  Daily till discharge 
 
Secondary Outcome  
Outcome  TimePoints 
appearance of any corneal opacification  Daily evaluation till discharge of the patient from critical care units 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial
Modification(s)  		 Phase 1/ Phase 2 
Date of First Enrollment (India)   18/03/2024 
Date of Study Completion (India) 31/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/12/2024 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  will be specified later on

  6. For how long will this data be available start date provided 11-03-2024 and end date provided 11-03-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  
The study aims to compare the effectiveness of prophylactic measures, including lubricating eye ointment, eye taping, and their combination, in preventing exposure keratopathy among critically ill patients. With a lack of such studies in the Indian population, this research becomes essential. Existing literature suggests promising results from interventions like passive blinking, carbomer eye drops, and polyethene covers. The study involves a prospective interventional approach over a year, focusing on patients in critical care units. Patients would be allocated into three groups, with ten patients in each group, using simple random sampling by the chit method. Double blinding would be followed as neither the patient nor the investigator giving the treatment is allocating the groups. Group A patients would receive eyelid taping; Group B patients would receive 2% hydroxypropyl methylcellulose eye ointment; and Group C patients would receive eyelid taping and 2% hydroxypropyl methylcellulose eye ointment. Ocular examination has to be done along with examination with fluorescein dye. Patients would be graded using following grading system to track progression of disease and its response to treatment.
 
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