| CTRI Number |
CTRI/2021/10/037204 [Registered on: 08/10/2021] Trial Registered Prospectively |
| Last Modified On: |
01/03/2023 |
| 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 Clinical Study to evaluate the efficacy, safety and tolerability of Lifitegrast 5% eye drops in patients with dry eye disease |
|
Scientific Title of Study
|
A randomized, double blind, parallel group, active controlled, multicentric, phase III study comparing the efficacy, safety and tolerability of
Lifitegrast 5% eye drops in patients with dry eye disease
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjula S |
| Designation |
Sr VP Medical Services |
| Affiliation |
Micro Labs Limited |
| Address |
31 Race Course Road
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
08022256323 |
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula S |
| Designation |
Sr VP Medical Services |
| Affiliation |
Micro Labs Limited |
| Address |
31 Race Course Road
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
08022256323 |
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Kumar M |
| Designation |
DGM Medical Services |
| Affiliation |
Micro Labs Limited |
| Address |
31 Race Course Road
Bangalore
KARNATAKA
560001
India |
| Phone |
08022370451 |
| Fax |
08022256323 |
| Email |
krishna@microlabs.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Micro Labs Limited |
| Address |
31 race course road Bangalore |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Micro Labs Limited |
31 race course road Bangalore |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Namrata Sharma |
All India Institute of Medical sciences, |
Room No. 481, 4th Floor,
Dr. Rajendra Prasad Centre for Ophthalmic Sciences,
All India Institute of Medical Sciences,
PIN code 110029
New Delhi
DELHI |
01126593144
namrata.sharma@gmail.com |
| Dr Ranjana A Pande |
BJ Government Medical College and Sassoon General Hospitals, Pune |
Dept of
Ophthalmology Jai
Prakash Narayan
Road, Near Pune
Railway Station,
Pincode 411001
Pune
MAHARASHTRA |
02026120161
ranjupande@gmail.com |
| Dr Hemaxi P Desai |
GCS Medical College, Hospital and Research Centre |
Opp. DRM office, Nr.Chamunda Bridge, Naroda Road
Ahmadabad
GUJARAT |
9898065645
ruhani91@yahoo.co.in |
| Dr P Seshu Babu |
Government Medical College & Government General Hospital , Srikakulam |
Dept of
Ophthalmology
Government Medical
College &
Government General
Hospital Pincode
532 001
Srikakulam
ANDHRA PRADESH |
08942279033
drseshubabupggh@yahoo.com |
| Dr Pramod Kumar |
King Georges Medical University |
Dept of
Ophthalmology,
Shah Mina Rd,
Chowk, Pincode
226003
Lucknow
UTTAR PRADESH |
05222258880
pramoddavid08@gmail.com |
| Dr Sayan Basu |
LV Prasad Eye Institute Hyderabad |
Kallam Anji Reddy
Campus,L.V Prasad
Marg, Banjara Hills,
Road No:2 Pincode
500034
Hyderabad
TELANGANA |
04068102020
sayanbasu@lvpei.org |
| Dr Rohit Shetty |
Narayana Netralaya Bangalore |
121 C CHORD ROAD 1ST R BLOCK RAJAJINAGAR
PIN code 560010
Bangalore
KARNATAKA |
08066121641
drrohitshetty@yahoo.com |
| Dr Anindita Mondal |
RIO Kolkata |
Regional Institute of Ophthalmology
Kolkata-88, College Street, Calcutta Medical College
Kolkata. West Bengal-700073
Kolkata
WEST BENGAL |
8334900196
aninditamondal65@gmail.com |
| Dr Kotadia Bhargav Jitendrakumar |
Shiv Jyoti Eye Hospital |
Opp Matrushakti Society, Besides Sales India, India Colony Road Bapunagar
Ahmadabad
GUJARAT |
7038163097
bjkotadia@gmail.com |
| Dr Shubhashree Karat |
St. Johns Medical College and Hospital |
Dept of Ophthalmology
Pincode 560034
Bangalore
KARNATAKA |
9900325184
shubashree.karat@gmail.com |
| Dr Richa Srivastava |
Vatsalya Hospital Multispeciality Center |
S-2/656, C4A Sikraul
Varanasi
UTTAR PRADESH |
8052226222
richa_ims@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee All India Institute of Medical Sciences NewDelhi |
Approved |
| Institutional Ethics Commiitee RIO Kolkata |
Approved |
| Institutional Ethics Committee BJ Medical College and Sassoon General Hospitals Pune |
Approved |
| Institutional Ethics Committee GCS medical college |
Approved |
| Institutional Ethics Committee Govt. Medical College Govt.General Hospital Srikakulam |
Approved |
| Institutional Ethics Committee King Georges Medical University lucknow |
Approved |
| Institutional Ethics Committee St. Johns Medical College Hospital, St Johns Medical College Bangalore |
Approved |
| L V Prasad Eye Institute Ethics Committee Hyderabad |
Approved |
| Narayana Nethralaya Ethics Committee, Bangalore |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| Vatsalya Ethics Committee |
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 |
Carboxymethylcellulose 0.5% eye drops |
BID for 12 weeks
|
| Intervention |
Lifitegrast 5% eye drops |
BID for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Subjects ≥18 years to 65 years of age both gender
• Subjects with known case of dry eye disease
• Subject on artificial tears for the past 30 days for DED
• Best Corrected Visual Acuity (BCVA) of 6/24 [Log MAR equivalent (0.6)] or better
• Normal lid position and closure.
• In case of women, postmenopausal (>12 months without menstrual bleeding),
• Surgically sterilized, or on use of effective birth control measures
• Willingness to sign written informed consent document
|
|
| ExclusionCriteria |
| Details |
• Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
• Any ocular condition that, in the opinion of the Investigator, could affect study parameters. This include, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy or, any other condition as deemed by the Investigator.
• Any significant illness that could interfere with study parameters
• History of any other ocular surgical procedure within 12 months
• Subject with known allergy or hypersensitivity to the components of the formulation
• Participation in another clinical trial within past 30 days
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The mean change in Eye dryness score |
baseline, Week-2, Week-6 and Week-12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The mean change in the Schirmer Tear Test (without anesthesia)
The mean change in Subject rated global improvement scale |
from baseline to Week-2, Week-6 and Week-12 |
|
|
Target Sample Size
|
Total Sample Size="370"
Sample Size from India="370"
Final Enrollment numbers achieved (Total)= "370"
Final Enrollment numbers achieved (India)="370" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/10/2021 |
| Date of Study Completion (India) |
08/11/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
To be decided |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Dry eye disease is a significant health burden. This study is designed to
assess the efficacy, safety and tolerability of Lifitegrast 5% eye drops versus
Carboxymethylcellulose 0.5% eye drops in patients with dry eye disease. The
mean changes in study variables from baseline to weeks 2, 6, and 12 within group
A and group B were statistically significant (p<0.001), suggesting that
subjects in both groups showed significant improvement at all study visits. The
changes were higher in group A as compared to group B, suggesting that subjects
treated with 5% lifitegrast showed greater improvement in signs and symptoms of
DED after 12 weeks of treatment compared to subjects treated with 0.5%
carboxymethylcellulose
|