| CTRI Number |
CTRI/2025/11/098126 [Registered on: 26/11/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Glaucoma Eye Drops Affect Eye Surface Health And Comfort |
|
Scientific Title of Study
|
Prevalence And Patterns of Ocular Surface Disease Among Glaucoma Patients On Topical Medications |
| 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 Sajjanshetty Vivek |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department Of Ophthalmology,Ground Floor,Avbrh Building,Sawangi (Meghe)
Wardha
Maharashtra
Department Of
Ophthalmology,Ground Floor,Avbrh Building,Sawangi (Meghe)
Wardha
Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9380877209 |
| Fax |
|
| Email |
sajjanshettyvivek646@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashank Banait |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department Of Ophthalmology,Ground Floor,Avbrh Building,Sawangi (Meghe)
Wardha
Maharashtra
Department Of Ophthalmology,Ground Floor,Avbrh Building,Sawangi (Meghe)
Wardha
Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9822226124 |
| Fax |
|
| Email |
shashankbanait@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashank Banait |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department Of Ophthalmology,Ground Floor,Avbrh Building,Sawangi (Meghe)
Wardha
Maharashtra
Department Of Ophthalmology,Ground Floor,Avbrh Building,Sawangi (Meghe)
Wardha
Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9822226124 |
| Fax |
|
| Email |
shashankbanait@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education And Research
Sawangi Meghe Wardha,Maharashtra India
442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Sawangi Meghe Wardha,India
442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sajjanshetty Vivek |
Acharya Vinoba Bhave Rural Hospital |
Room No-24 Department Of Ophthalmology,Ground Floor,Avbrh Building A Block,Sawangi (Meghe)
Wardha
Maharashtra
India
442001
Wardha
MAHARASHTRA |
9380877209
sajjanshettyvivek646@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE DMIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H409||Unspecified glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Day(s) |
| Age To |
99.00 Day(s) |
| Gender |
Both |
| Details |
DIAGNOSED CASES OF GLAUCOMA (PRIMARY OPEN ANGLE, ANGLE CLOSURE,
PSEUDOEXFOLIATION, PIGMENTARY GLAUCOMA)
ON TOPICAL ANTIGLAUCOMA MEDICATIONS FOR MORE THAN 6 MONTHS
WILLINGNESS TO PROVIDE WRITTEN INFORMED CONSENT.
SUBJECTS NOT USING ANY TOPICAL OCULAR MEDICATIONS
|
|
| ExclusionCriteria |
| Details |
USE OF TOPICAL STEROIDS OR LUBRICANTS
HISTORY OF OCULAR SURGERY
SECONDARY GLAUCOMA (E.G., UVEITIC, LENS-INDUCED)
CONTACT LENS USERS
KNOWN SYSTEMIC DISEASES AFFECTING TEAR FILM (E.G., SJOGRENS SYNDROME) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
TO IDENTIFY CLINICAL AND DEMOGRAPHIC RISK FACTORS (E.G., AGE,
COMORBIDITIES, POLYPHARMACY) ASSOCIATED WITH OCULAR SURFACE DISEASES IN GLAUCOMA
PATIENTS. |
1ST DAY & 15TH DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TO DETERMINE THE PREVALENCE AND SEVERITY OF OSD IN GLAUCOMA
PATIENTS (EG- USING OSDI (OCULAR SURFACE DISEASES INDEX), TBUT(TEAR BREAKUP TIME), SCHIRMER’S TEST, AND LISSAMINE
GREEN STAINING).
TO COMPARE THESE FINDINGS WITH HEALTHY CONTROLS.
TO ASSESS THE CORRELATION BETWEEN OSD (OCULAR SURFACE DISEASES) SEVERITY AND
NUMBER/DURATION OF ANTIGLAUCOMA MEDICATIONS.
TO ASSESS THE IMPACT OF PRESERVATIVE-CONTAINING VERSUS
PRESERVATIVE-FREE FORMULATIONS ON OCULAR SURFACE PARAMETERS.
TO EXPLORE TREATMENT PATTERNS AND GAPS IN THE CURRENT MANAGEMENT
OF OSD IN GLAUCOMA |
1ST & 15TH DAY |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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
|
N/A |
|
Date of First Enrollment (India)
|
13/12/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
|