| CTRI Number |
CTRI/2025/07/091185 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Compare the Effectiveness of Three Eye Drops in Treating Moderate to Severe Dry Eyes |
|
Scientific Title of Study
|
A Comparative study of Chloroquine
Cyclosporine and Lifitegrast in the management of Dry eye Disease-Clarity Trial |
| Trial Acronym |
CLARITY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHWETA DHIMAN |
| Designation |
SENIOR CONSULTANT ROTARY EYE HOSPITAL |
| Affiliation |
JPM ROTARY EYE HOSPITAL AND RESEARCH INSTITUTE |
| Address |
Room no.101 JPM Rotary eye Hospital and reasearch centre CDA, Sector-VI, Bidanasi, Cuttack
Cuttack
ORISSA
753014
India |
| Phone |
9315157276 |
| Fax |
|
| Email |
dr.shwetadhiman@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHWETA DHIMAN |
| Designation |
SENIOR CONSULTANT ROTARY EYE HOSPITAL |
| Affiliation |
JPM ROTARY EYE HOSPITAL AND RESEARCH INSTITUTE |
| Address |
Room number 101 ,JPM rotary eye Hospital and reasearch centre CDA Sector-VI, Bidanasi, Cuttack
Cuttack
ORISSA
753014
India |
| Phone |
9315157276 |
| Fax |
|
| Email |
dr.shwetadhiman@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
SHWETA DHIMAN |
| Designation |
SENIOR CONSULTANT ROTARY EYE HOSPITAL |
| Affiliation |
JPM ROTARY EYE HOSPITAL AND RESEARCH INSTITUTE |
| Address |
Room number 101 ,JPM rotary eye hospital and reasearch center CDA, Sector-VI, Bidanasi, Cuttack
Cuttack
ORISSA
753014
India |
| Phone |
9315157276 |
| Fax |
|
| Email |
dr.shwetadhiman@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JPM Rotary Club of Cuttack Eye Hospital and Research Institute |
| Address |
JPM Rotary Club of Cuttack Eye Hospital and Research Institute CDA, Sector-VI, Bidanasi, Cuttack – 753014, Odisha, India |
| 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 |
| Shweta Dhiman |
JPM Rotary Club of Cuttack Eye Hospital and Research Institute |
Room no.101, JPM Rotary Club of Cuttack Eye Hospital and Research Institute CDA, Sector-VI, Bidanasi, Cuttack – 753014, Odisha, India
Cuttack
ORISSA |
9315177276
dr.shwetadhiman@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee,JPM Rotary Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H04||Disorders of lacrimal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chloroquine 0.03 percent eye drops
|
Given to moderate to severe dry eye patients one drop in each eye Four times daily |
| Comparator Agent |
Cyclosporine 0.05 percent eye drops
|
Given to moderate to severe dry eye patients one drop in each eye thrice daily |
| Intervention |
Lifitegrast 5 percent eye drops |
Given to moderate to severe dry eye patients one drop in each eye twice daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed dry eye based on OSDI score lesser than 13 and TBUT lesser than 10 sec
Schirmer test lesser than 10 mm without anesthesia
Willing to provide informed consent and comply with study procedures |
|
| ExclusionCriteria |
| Details |
Presence of ocular surface diseases that might interfere with dry eye assessment example severe blepharitis active ocular infections, allergic conjunctivitis
History of ocular surgery in the past 6 months
Use of systemic medications affecting tear production or ocular surface
Known hypersensitivity or contraindication to chloroquine, lifitegrast, or cyclosporine
Pregnant or breastfeeding women
Any systemic illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tear Breakup Time Improvement from baseline to 12 weeks
Ocular Surface Disease Index Score Change from baseline to 12 weeks |
Tear Breakup Time Improvement from baseline to 12 weeks
Ocular Surface Disease Index Score Change from baseline to 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Schirmer’s Test (without anesthesia): Tear production
Corneal and conjunctival staining (fluorescein and lissamine green): Ocular surface assessment
Patient-reported symptom relief and quality of life: Using standardized dry eye questionnaire |
Schirmer’s Test and staining: Baseline (Week 0) and Week 12
Patient-reported symptom relief and quality of life: Baseline (Week 0), Week 4, Week 8, and Week 12 |
|
|
Target Sample Size
|
Total Sample Size="225"
Sample Size from India="225"
Final Enrollment numbers achieved (Total)= "225"
Final Enrollment numbers achieved (India)="225" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/07/2025 |
| Date of Study Completion (India) |
28/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/01/2027 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
The CLARITY trial is a randomized double blind parallel group active controlled clinical trial designed to compare the efficacy and safety of three topical anti inflammatory agents chloroquine 003 percent lifitegrast 5 percent and cyclosporine 005 percent in the treatment of moderate to severe dry eye disease DED A total of 225 participants 75 per group will be enrolled and followed for 12 weeks at a single tertiary care center in Odisha India Primary outcomes include changes in Tear Break Up Time TBUT and Ocular Surface Disease Index OSDI scores from baseline to week 12 Secondary outcomes include Schirmers test corneal and conjunctival staining and patient reported quality of life measures This study aims to provide comparative data to guide the selection of anti inflammatory agents for managing moderate to severe DED including evaluation of the emerging role of topical chloroquine
|