| CTRI Number |
CTRI/2019/05/019304 [Registered on: 23/05/2019] Trial Registered Prospectively |
| Last Modified On: |
20/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To compare the effect of combined treatment with chloroquine and olopatadine eye drops with treatment with olopatadine eye drops alone in patients with allergic conjunctivitis |
|
Scientific Title of Study
|
Comparative evaluation of combined treatment using 0.03% chloroquine phosphate and 0.1% olopatadine eye drops with monotherapy using 0.1% olopatadine eye drops in patients with allergic conjunctivitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Namrata Sharma |
| Designation |
Professor of Ophthalmology |
| Affiliation |
MD, MNAMS |
| Address |
Dr. Rajendra Prasad Centre for Ophthalmic sciences
All India Institute of Medical Sciences
New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
namrata.sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Namrata Sharma |
| Designation |
Professor, Department of ophthalmology |
| Affiliation |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences AIIMS New Delhi |
| Address |
Room Number 481
Fourth floor
Dr. Rajendra Prasad Centre for Ophthalmic Sciences
AIIMS
New Delhi
South
DELHI
110029
India |
| Phone |
011-2659-3144 |
| Fax |
|
| Email |
namrata.sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Namrata Sharma |
| Designation |
Professor, Department of ophthalmology |
| Affiliation |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences AIIMS New Delhi |
| Address |
Room Number 481
Fourth floor
Dr. Rajendra Prasad Centre for Ophthalmic Sciences
AIIMS
New Delhi
South
DELHI
110029
India |
| Phone |
011-2659-3144 |
| Fax |
|
| Email |
namrata.sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| R.P Centre , AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
RP Centre |
| Address |
Ocular pharmacology department
R.P Centre
AIIMS, New Delhi |
| 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 |
| Ritu Nagpal |
AIIMS, NEW Delhi |
Dr. R.P Centre for Ophthalmic Sciences
South
DELHI |
7015791954
doc.ritunagpal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H101||Acute atopic conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chloroquine |
0.03% Chloroquine phosphate drops + 0.1% Olopatadine drops twice a day
for 1 year |
| Comparator Agent |
Olopatadine |
0.1% Olopatadine drops + 0.5% Carboxy methyl cellulose twice a day
for 1 year |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
All patients attending the outpatient department with clinically diagnosed allergic eye disease based on signs (itching, watering) and symptoms (conjunctival hyperemia, palpebral hypertrophy) will participate in the study. No other methods of diagnosis will be considered besides clinical signs and symptoms. |
|
| ExclusionCriteria |
| Details |
1. Uveitis, conjunctivitis and other ocular pathologies
2. Bronchial asthma, eczema
3. History of dry eye, blepharitis, contact lens use
4. Receiving topical or systemic medications
5. History of sensitivity to any constituents of the eye drops
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in ocular symptoms including eye itching and rubbing
|
1 week, 4 weeks, 2 months, 3 months, 6 months, 9 months, 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Alterations in Inflammatory markers in tear film(Alpha- Antitrypsin, MMP9, IL-1, IL-8, IFN gamma) |
4 weeks, 3 months, 6 months, 9 months, 1 year |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 2 |
|
Date of First Enrollment (India)
|
01/06/2019 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not submitted anywhere for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Allergic eye disease is an important cause of ocular morbidity in young healthy individuals. Adequate control of disease requires long term use of corticosteroids in combination with other anti-allergics. Effective control of allergy is important since many of these patients have underlying co-morbidities such as keratoconus and are contact lens users. Topical agents with effective ant-inflammatory properties but without any adverse effects will help avoid the long term use of corticosteroids in these patients. This randomized study aims to compare a newer drug named chloroquine, with established anti-inflammatory properties for the management of cases with allergic conjunctivitis. The study will be conducted as a placebo controlled trial involving 200 subjects over a period of 3 years. Adequate control of symptoms will be considered as the primary outcome measure and changes in tear film inflammatory markers will be considered as the secondary outcome measure. The patients will be given treatment for a period of 1 year. Evaluation of parameters will be done at 1 week, 4 weeks, 2 months, 3 months, 6 months, 9 months and at 1 year follow up period. |