| CTRI Number |
CTRI/2025/09/094154 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effects of 2 drugs, Cyclosporine 0.09% and Lifitegrast 5% in patients with dry eye disease |
|
Scientific Title of Study
|
Comparison of efficacy and adverse effects of Cyclosporine 0.09% and Lifitegrast 5% in patients with dry eye disease- A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarama S Raj |
| Designation |
DNB Resident |
| Affiliation |
Chaithanya Eye Hospital And Research Institute |
| Address |
Department of Ophthalmology
Cornea and Ocular Surface
Room No 1001
Chaithanya Eye Hospital And Research Institute, Kesavadasapuram, Thiruvananthapuram
Kerala
695004
India
Department of Ophthalmology
Cornea and Ocular Surface
Room No 1001
Chaithanya Eye Hospital And Research Institute, Kesavadasapuram, Thiruvananthapuram
Kerala
695004
India
Thiruvananthapuram
KERALA
695004
India |
| Phone |
9495246083 |
| Fax |
|
| Email |
saramasraj13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abraham Kurian |
| Designation |
Senior Consultanat |
| Affiliation |
Chaithanya Eye Hospital And Research Institute |
| Address |
Department of Ophthalmology
Cornea and Ocular Surface
Room No 1001
Chaithanya Eye Hospital And Research Institute, Kesavadasapuram, Thiruvananthapuram
Kerala
695004
India
Department of Ophthalmology
Cornea and Ocular Surface
Room No 1001
Chaithanya Eye Hospital And Research Institute, Kesavadasapuram, Thiruvananthapuram
Kerala
695004
India
Thiruvananthapuram
KERALA
695004
India |
| Phone |
9495246083 |
| Fax |
|
| Email |
abkurian@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sarama S Raj |
| Designation |
DNB Resident |
| Affiliation |
Chaithanya Eye Hospital And Research Institute |
| Address |
Department of Ophthalmology
Cornea and Ocular Surface
Room No 1001
Chaithanya Eye Hospital And Research Institute, Kesavadasapuram, Thiruvananthapuram
Kerala
695004
India
Department of Ophthalmology
Cornea and Ocular Surface
Room No 1001
Chaithanya Eye Hospital And Research Institute, Kesavadasapuram, Thiruvananthapuram
Kerala
695004
India
Thiruvananthapuram
KERALA
695004
India |
| Phone |
9495246083 |
| Fax |
|
| Email |
saramasraj13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaithanya Eye Hospital and Research Institute |
|
|
Primary Sponsor
|
| Name |
Chaithanya Eye Hospital and Research Institute |
| Address |
Chaithanya Eye Hospital And Research Institute, Kesavadasapuram, Trivandrum |
| 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 |
| Sarama S Raj |
Chaithanya Eye Hospital |
Department of Ophthalmology
Cornea and Ocular Surface
Room No. 1001
Thiruvananthapuram
KERALA |
9495246083
saramasraj13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CEHRI-Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H119||Unspecified disorder of conjunctiva, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lifitegrast 5% |
Lifitegrast 5% is a LFA 1 antagonist used to treat dry eye disease |
| Comparator Agent |
Cyclosporine 0.09% |
Cyclosporine 0.09% is calcineurin inhibitor immunosuppressant used in treating patients with dry eye disease |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects included in this study are those who are above 18 years of age with clinical signs of dry eye disease and have been advised Cyclosporine 0.09% or Lifitegrast 5% |
|
| ExclusionCriteria |
| Details |
1. Patients who have undergone any other forms of dry eye therapy like IPL, IRPL, Lipiflow
2. Patients not willing to participate in our study
3. Patients who are not willing to follow-up in our study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of symptoms of dry eye disease |
at base line 1 Month and 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Discontinued any drug due to adverse effect |
base line 1 month & 6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="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
|
Background
Dry eye disease also known as Keratoconjunctivitis sicca is a complex disorder of ocular surface characterized by symptoms of visual disturbances eye discomforts and dryness due to tear film instability.
Purpose
Comparison of efficacy and adverse effects of Cyclosporine 0.09% and Lifitegrast 5% in patients with dry eye disease. Patients included in the study are those who are having clinical signs of dry eye disease and have been advised Cyclosporine 0.09% or Lifitegrast 5%.
Adverse Effects
Adverse effects of Cyclosporine 0.09% includes burning stinging conjunctival hyperemia and reactivations of Herpes Simplex Keratitis. Adverse effects of Lifitegrast 5% includes transient instillation site irritation eye irritation decreased visual acuity blepharitis blurred vision and altered taste sensation
|