| CTRI Number |
CTRI/2026/01/100909 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
"Role of Cyclosporine in treating Eye Surface Damage Caused by Long term Glaucoma Medication" |
|
Scientific Title of Study
|
Effectiveness of Topical 0.05 percent Cyclosporine in ocular surface disease among long term Antiglaucoma drugs users |
| 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 Garima |
| Designation |
JUNIOR RESIDENT ACADEMICS |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR UTTAR PRADESH INDIA |
| Address |
Room number 130 ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR UTTAR PRADESH INDIA
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
7988623845 |
| Fax |
|
| Email |
garimagilyawat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Singh |
| Designation |
Associate Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR UTTAR PRADESH INDIA |
| Address |
Room number 129 ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR UTTAR PRADESH INDIA
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9958552139 |
| Fax |
|
| Email |
nhsngh.89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Garima garima |
| Designation |
JUNIOR RESIDENT ACADEMICS |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR UTTAR PRADESH INDIA |
| Address |
Room number 130 ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR UTTAR PRADESH INDIA
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
7988623845 |
| Fax |
|
| Email |
garimagilyawat@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR UTTAR PRADESH INDIA |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Kunraghat,Gorakhpur,Uttar Pradesh, 273008 |
| 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 |
| Dr Garima |
All India Institute of Medical Sciences ,GORAKHPUR |
Department of Ophthalmology
Gorakhpur
UTTAR PRADESH |
7988623845
garimagilyawat@gmail com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee , All India Institute of Medical SCIENCES, Gorakhpur, India 273008 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H118||Other specified disorders of conjunctiva, (2) ICD-10 Condition: H42||Glaucoma in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Topical cyclosporine 0.05 percent, Topical sodium hyaluronate 0.01 percent |
Patient on topical antiglaucoma medication one group will be given topical cyclosporine 0.05 percent along with topical antiglaucoma medication and other group will be given topical sodium hyaluronate 0.01 % along with topical antiglaucoma medication, then effectiveness of both drugs will be compared after 8 weeks on the basis of 8 outcome variables |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having ocular surface disease after taking antiglaucoma drugs at least for 6 months.
2 Patients taking combination therepy of topical antiglaucoma drugs (beta blocker+ alpha 2 adrenergic agonist) with or without prostaglandin analogue for at least 6 months.
3. Patients giving consent for study. |
|
| ExclusionCriteria |
| Details |
1. Patients using contact lens.
2. Patients undergone punctal occlusion treatment or punctal cauterisation.
3. Patients undergone intraocular surgery and ocular laser treatment within last 6 months.
4. Patients allergic to cyclosporine.
5.Patients using eye drops other than topical antiglaucoma drugs including artificial tear therepy.
6. Patients with pre existing ocular surface morbidities like recent ocular infection or inflammation, autoimmune disease, conjunctivitis, cicatricial conjunctivitis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in
1 Best corrected visual acuity
2 Intraocular pressure
3 Ocular surface disease index questionnaire
4 Schirmer tear test
5 Tear film break up time
6 Impression cytology (By Nelson grade
7 Corneal Staining
8 Tear film height |
1year and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
21/01/2026 |
| 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="6"
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
|
This is a Hospital based Prospective Comparative study , in which 150 glaucoma patients on 2 or more topical antiglaucoma medication ( beta blocker + alpha 2 adrenergic agonist ) with or without prostaglandin analogue at least for 6 months will be recruited from OPD basis . Patients will be recruited after matching all inclusion and exclusion criteria and those who are willing to participate in study . Patients will be divided in 2 groups 1 group will be given topical cyclosporine 0.0.05 % along with topical antiglaucoma medication and other group will be given topical sodium hyaluronate 0.01% along with topical antiglaucoma medication. Results will be compared in 8 outcome variables BCVA ( best corrected visual acuity), IOP ( intraocular pressure) , OSDI ( OCULAR SURFACE DISEASE INDEX), Schirmer test, TBUT ( Tear film break up time) , Conjunctival impression cytology by Nelson grading, Corneal staining, Tear film height . Outcome variables will be measured at time of recruitment for both cases and control and again at 8wk follow up. Then effectiveness of topical cyclosporine 0.05% will be compared to topical sodium hyaluronate 0.01% after completion of follow up at 8 weeks . |