| CTRI Number |
CTRI/2024/08/072868 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effects of eye drop cyclosporine 0.05% on patients having dry eye disease |
|
Scientific Title of Study
|
An Observational Study To Assess The Clinical Changes Of Topical Cyclosporine 0.05 percent Ophthalmic Solution In The Management Of Mild To Moderate Dry Eye Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dharamveer S Choudhary |
| Designation |
Professor |
| Affiliation |
Swai man singh medical college Jaipur |
| Address |
Department of Ophhalmology,S.M.S Medical college JLN Road ,jaipur
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
9252032662 |
| Fax |
|
| Email |
drdschoudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dharamveer S Choudhary |
| Designation |
Professor |
| Affiliation |
Swai man singh medical college Jaipur |
| Address |
Department of Ophhalmology,S.M.S Medical college JLN Road ,jaipur
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
9252032662 |
| Fax |
|
| Email |
drdschoudhary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raman |
| Designation |
resident doctor |
| Affiliation |
SMS Medical college ,Jaipur |
| Address |
Department of ophthalmology,sms medical college ,JLN Road jaipur ,Rajasthan
jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
7727888469 |
| Fax |
|
| Email |
beniwalraman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of ophthalmology Charak Bhavan Swaiman Singh medical college and hospital, Jawahar Lal Nehru marg Jaipur ,302004 |
|
|
Primary Sponsor
|
| Name |
SMS medical college Jaipur |
| Address |
Department of ophthalmology charak bhawan SMS Medical college Jawahar lal nehru marg Jaipur 302004 |
| 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 |
| Dharamveer S Choudhary |
S.M.S medical college jaipur |
Department of ophthalmology ,S.M.S Medical college JLN Road jaipur
Jaipur
RAJASTHAN |
9252032662
drdschoudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Ethics Comittee S.M.S Medical college and Attached Hospital Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H55-H57||Other disorders of eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Eye drop cyclosporine 0.05% |
Dose-1 drop
Frequency -two times in a day in affected eye
Route -topical
Duration- 6 months
Cyclosporine is class of immunomodulators drugs .in eye it work by decreasing inflammation and hence stabilise tear film. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients who will give written informed consent.
Patients with history of dry eye disease for a period of at least 6 months.
patients with corrected Snellen VA of 20/200. |
|
| ExclusionCriteria |
| Details |
Patients with a history of hypersensitivity or intolerability to study medication or its component.
patient with presence of punctal plugs or past history of permanent punctal occlusion.
patient with lagophthalmos or clinically significant eyelid margin irregularity of either eye whether congenital or acquired. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Dry eye sign and symptoms |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in BCVA |
4 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
12/09/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response (Others) - can be shared as per law
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identiļ¬ed for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - data will be available with authorities at SMS medical college jaipur as per law.
- For how long will this data be available start date provided 26-11-2025 and end date provided 25-11-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nill
|
|
Brief Summary
|
Dry eye syndrome (DES) is a multifactorial disease of the ocular surface with tear film abnormalities, leading to eye discomfort, visual disturbance, tear film instability,
and inflammation of the ocular surface.1 DES accounts for as many as 17%-25% of visits to ophthalmology clinics making it one of the most common ocular conditions.
Patients with uncontrolled and chronic DES are at risk for ocular infections however, due to the natural defence mechanisms of the eye, overt intraocular infections are
relatively uncommon.Traditional therapies for DES mainly focus on the lubrication of the ocular surface with artificial tears. However, these treatments do not address the underlying ocular
surface inflammation. Cyclosporine, an immunomodulatory agent, has been shown to block T-cell proliferation and receptor signal transduction. The cell-mediated
inflammatory responses are modulated through the downregulation of IL-2 receptor expression and gene transcription.Because of the properties noted above, topical
cyclosporine eye drops are indicated for the treatment of DES.
|