| CTRI Number |
CTRI/2025/09/094422 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Audit of Anti Glaucoma Drug Utilization and their effects on ocular surface |
|
Scientific Title of Study
|
Clinical Audit of Anti-Glaucoma Drug Utilization Pattern and their impact on ocular surface |
| 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 Kirti Singh |
| Designation |
Director Professor |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604334 |
| Fax |
|
| Email |
mail4kirti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DIKSHA KUMAR |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8585951122 |
| Fax |
|
| Email |
kumardiksha2016@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DIKSHA KUMAR |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8585951122 |
| Fax |
|
| Email |
kumardiksha2016@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Eye Centre, Maharaja Ranjit Singh Road, Asaf Ali Road, Delhi 110002, India |
|
|
Primary Sponsor
|
| Name |
Guru Nanak Eye Centre |
| Address |
Guru Nanak Eye Centre, Maharaja Ranjit Singh Road, Asaf Ali Road, Delhi 110002 |
| Type of Sponsor |
Government 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 |
| Diksha Kumar |
Guru Nanak Eye Centre |
Room No 204 Glaucoma Clinic, Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College New Delhi
New Delhi
DELHI |
8585951122
kumardiksha2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, (2) ICD-10 Condition: H402||Primary angle-closure glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with primary glaucoma of age 18 years and Above on more than 1 anti- glaucoma drops of more Than 3 month duration |
|
| ExclusionCriteria |
| Details |
Pre existing diagnosis of ocular surface disease Eg dry eyes
Prior intra ocular surgery within 12 months of enrollment
Allergic conjunctival disorders
Patients having systemic disorders eg Diabetes Mellitus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical audit of drug utilization practices in glaucoma referrals |
52 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of patients using anti glaucoma drugs having meibomian gland dysfunction Meiboscale by Phoenix software
Proportion of patients having polypharmacy associated ocular side effects |
52 weeks |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
16/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is a hospital based observation cross sectional study evaluating 104 eyes of glaucoma patients on multiple anti glaucoma medications. A clinical audit of prescribing patterns of anti glaucoma medications will be conducted. Assessment of ocular surface will be done using Ocular Surface Disease Index Questionnaire and clinical evaluation will be done using tests such as Tear film Break Up Time, Non Invasive Tear Film break up time, Schirmer’s Test, corneal fluorescein staining and conjunctival staining by lissamine green stain and Meibography. |