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CTRI Number  CTRI/2025/07/089950 [Registered on: 01/07/2025] Trial Registered Prospectively
Last Modified On: 20/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Comparing two Dry eye questionnaire in individuals who are at risk of developing dry eye. 
Scientific Title of Study   Comparison of Ocular Surface Disease Index and Short Dry Eye Questionnaire among individuals with risk of developing Dry Eye. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Srishti S Nayak 
Designation  Student Pursuing Master of Optometry 
Affiliation  Manipal College of Health professions, Manipal Academy of Higher Education, Manipal 
Address  Department of Optometry, Manipal College of Health professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  06360447984  
Fax    
Email  sristhi.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr. Judy Jose 
Designation  Assistant Professor –Selection Grade 
Affiliation  Manipal College of Health professions 
Address  Room number 303 Department of Optometry, Manipal College of Health professions, Manipal Academy of Higher Education, Manipal, Udupi

Udupi
KARNATAKA
576104
India 
Phone  8884109939  
Fax    
Email  judy.jose@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Srishti S Nayak 
Designation  Student Pursuing Master of Optometry 
Affiliation  Manipal College of Health professions, Manipal Academy of Higher Education, Manipal 
Address  Department of Optometry, Manipal College of Health professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  06360447984  
Fax    
Email  sristhi.mchpmpl2024@learner.manipal.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Department of Optometry, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal-576104, Udupi, Karnataka, India 
Type of Sponsor  Research institution and hospital 
 
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 Judy Jose  Kasturba Hospital Manipal  Room number 9, 2nd floor, Department of Ophthalmology, New OPD
Udupi
KARNATAKA 		 8884109939

judy.jose@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy participants 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.11 Year(s)
Gender  Both 
Details  Age from 18 to 59
Individuals using digital devices more than 4 hours per day
Participant who can understand English and answer the questionnaire
 
 
ExclusionCriteria 
Details  Any active infection or inflammation of eye 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Schirmer test I & II the wet Schirmer strip is measured in mm per 5 minutes.
Tear breakup time is measured in seconds.
Ocular surface disease index is measured in terms of score from 0 to 100 where greater than 13 is presence and less than 13 is absence of dry eye.
Short Dry Eye Questionnaire is measured in terms of score that is from 2 to 8 where greater than 6 is presence and less than 6 is absence of dry eye

 		 measured in 10 months of time 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
Final Enrollment numbers achieved (Total)= "220"
Final Enrollment numbers achieved (India)="220" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2025 
Date of Study Completion (India) 19/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Dry eye is a multifactorial condition having a global prevalence of 11.59 percentage according to 2021 study. studies have shown that as age increases the dryness of eye increases. There are several test to measure dry eyes quantitatively and qualitatively. Ocular surface disease index is a questionnaire that is used to assess the severity of the symptoms of dry eyes. Short dry eye questionnaire is a concise tool suitable for epidemiological studies. Authors have investigated the prevalence and risk factors of dry eye, conducted epidemiological studies, and developed and validated various questionnaires. Ocular surface disease index is used to see severity of dry eye. Short dry eye questionnaire has a diagnostic ability of dry eye. Research could not find any evidence on comparison of Short dry eye questionnaire against Ocular surface disease index questionnaire. Though the Ocular surface disease index questionnaire is commonly used all over the world, it is better to have a shorter questionnaire which can diagnose dry eye in a busy clinical practice. Short Dry Eye Questionnaire is short with 3 questions. Therefore it is necessary to find whether Short dry eye questionnaire is comparable to Ocular surface disease index questionnaire.
 
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