| CTRI Number |
CTRI/2025/07/091757 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing two eye drops, cyclosporine and lifitegrast, for patients with dry eye disease |
|
Scientific Title of Study
|
Comparative study on efficacy between topical 0.05% Cyclosporine and topical 5% Lifitegrast in 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 |
Dr Lakshitha N |
| Designation |
Primary DNB Resident (Ophthalmology) |
| Affiliation |
Sankara Eye Hospital, Shivamogga |
| Address |
Sankara Eye Hospital, Thirthahalli road, Harakere, Shivamogga, Karnataka, 577202, India
Shimoga
KARNATAKA
577202
India |
| Phone |
9994563827 |
| Fax |
|
| Email |
lakshya.gowda1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopasree B V |
| Designation |
Consultant Department of Cornea |
| Affiliation |
Sankara Eye Hospital, Shivamogga |
| Address |
Room no. 11
Sankara Eye Hospital, Thirthahalli road, Harakere, Shivamogga, Karnataka, 577202, India
Shimoga
KARNATAKA
577202
India |
| Phone |
8884920286 |
| Fax |
|
| Email |
dr.roopasree@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshitha N |
| Designation |
Primary DNB Resident (Ophthalmology) |
| Affiliation |
Sankara Eye Hospital, Shivamogga |
| Address |
Sankara Eye Hospital, Thirthahalli road, Harakere, Shivamogga, Karnataka, 577202, India
Shimoga
KARNATAKA
577202
India |
| Phone |
9994563827 |
| Fax |
|
| Email |
lakshya.gowda1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, Shivamogga |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital, Shivamogga |
| Address |
Sankara Eye Hospital, Thirthahalli road, Harakere, Shivamogga, Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Lakshitha N |
Sankara Eye Hospital, Shivamogga |
Sankara Eye Hospital, Thirthahalli road, Harakere, Shivamogga, Karnataka, 577202, India
Shimoga
KARNATAKA |
9994563827
lakshya.gowda1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Sankara Eye Hospital, Shivamogga |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H041||Other disorders of lacrimal gland, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cyclosporine eye drops |
Treatment in Dry eyes |
| Comparator Agent |
Lifitegrast Eye drops |
Treatment in Dry eyes |
| Intervention |
Topical medications, Cyclosporine and Lifitegrast eye drops will be advised to dry eye patients. |
Two group of patients in our study. One group will receive Cyclosporine eye drops and the other group will receive Lifitegrast eye drops. we will study efficacy in both the groups and compare. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients who are diagnosed to have Moderate or Severe Dry eye disease
2 Who are compliant to medication
3 Willing to give consent for study
|
|
| ExclusionCriteria |
| Details |
1 H/o using steroid eye drops in past one month
2 Presence of other ocular co morbidities - glaucoma, lid abnormalities
3 Presence of MGD
4 H/o ocular trauma or infection in past 3 months
5 Corneal disorders affecting sensitivity
6 H/o Contact lens usage in past 3 months
7 Pregnant and lactating mothers
8 H/o intraocular surgery, refractive surgery in past 3 months
9 Presence of allergic conjunctivitis
10 H/o viral keratitis
11 Presence of pterygium
12 H/o punctal plug usage in last 3 months
13 H/o Steven-Jonson Syndrome, Ocular Pemphigoid
14 H/o usage of topical cyclosporine in past 3 months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the objective parameters which includes Schirmer tear test, Tear Break Up Time, Corneal and Conjunctival fluorescein staining, in patients treated with 0.05 percent Cyclosporine versus 5 percent Lifitegrast in dry eye disease |
At presentation, Day 15 and Day 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the subjective response (OSDI) in patients treated with 0.05% Cyclosporine versus 5% Lifitegrast in Dry eye disease |
At presentation, Day 15 and Day 45 |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
16/08/2025 |
| 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="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
|
Dry eye disease (DED) is defined as a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles. The prevalence of this is 29.5% globally and 17.7% in India. Dry Eye Disease severely interferes with a number of crucial everyday tasks, and has become serious public health concern that needs greater funding and attention. This study compares the efficacy between the two eye drops, 0.05% cyclosporine twice daily and 5% Lifitegrast twice daily for 45 days in 42 patients with moderate to severe dry eye disease. The primary outcome measures objective parameters which includes Schirmer tear test, Tear Break Up Time, Corneal and Conjunctival fluorescein staining and the secondary outcome measures subjective response with OSDI questionnaire on day 1, day 15 and day 45. |