| CTRI Number |
CTRI/2018/09/015679 [Registered on: 11/09/2018] Trial Registered Prospectively |
| Last Modified On: |
13/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing the effect of chloroquine eye drops with olopatidine drops versus olopatidine eye drops alone in patients of allergic keratoconjunctivitis. |
|
Scientific Title of Study
|
Comparative evaluation of combined 0.03% chloroquine phosphate with 0.1% olopatidine versus 0.1% olopatidine drops in cases of allergic keratoconjunctivitis. |
| 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 |
| Affiliation |
Dr.R.P.Centre for Ophthalmic Sciences, AIIMS |
| Address |
Room no 481, 4th floor, Dr.R.P.Centre for Ophthalmic Sciences, AIIMS, New Delhi-110029
South DELHI 110029 India |
| Phone |
011-26593144 |
| Fax |
|
| Email |
namrata.sharma@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Namrata Sharma |
| Designation |
Professor |
| Affiliation |
Dr.R.P.Centre for Ophthalmic Sciences, AIIMS |
| Address |
Room no 481, 4th floor, Dr.R.P.Centre for Ophthalmic Sciences, AIIMS, New Delhi-110029
South DELHI 110029 India |
| Phone |
011-26593144 |
| Fax |
|
| Email |
namrata.sharma@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Namrata Sharma |
| Designation |
Professor |
| Affiliation |
Dr.R.P.Centre for Ophthalmic Sciences, AIIMS |
| Address |
Room no 481, 4th floor, Dr.R.P.Centre for Ophthalmic Sciences, AIIMS, New Delhi-110029
South DELHI 110029 India |
| Phone |
011-26593144 |
| Fax |
|
| Email |
namrata.sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Company : FDC ltd. C-3 Sky Vistas 106-A,
J.P Road, D.N Nagar,
Near Versova Police Station
Next to Barfiwala College
Andheri ( W ) - Mumbai 400053
Maharshtra - India |
|
|
Primary Sponsor
|
| Name |
FDC Limited |
| Address |
FDC Limited
C-3 Sky Vistas 106-A
J.P Road, D.N Nagar,
Near Versova Police Station
Next to Barfiwala College
Andheri ( W ) - Mumbai 400053
Maharshtra - India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Namrata Sharma |
Dr.R.P.Centre for Ophthalmic Sciences, AIIMS |
Dr.R.P.Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar, Delhi South DELHI |
01126593144
namrata.sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Allergic keratoconjunctivitis, (1) ICD-10 Condition: H162||Keratoconjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Chloroquine phosphate |
It is the phosphate salt of chloroquine, a quinoline compound with antimalarial and anti-inflammatory properties.
route of administration- topical (ocular)
dose of administration-
twice a day
total duration of therapy-
three months |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients coming in the outpatient department with ocular itching, redness and watering and diagnosed as a case of seasonal allergic conjunctivitis on the basis of sign (hyperemia and papillaae) at slit lamp examination. |
|
| ExclusionCriteria |
| Details |
1. Uveitis, conjunctivitis (due to other cause) and other ocular pathology.
2. Bronchial asthma, eczema.
3. History of dry eye, blepharitis, using contact lens.
4. Receiving topical or systemic medication.
5. History of hypersensitivity to any constituents of the eye drops. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Symptom control
|
follow up 1week, 4 week, 8 week and 12 week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. decrease in tear osmolarity
2. decrease in Inflammtory markers MMP9 Alpha antitrypsin, Interleukin1, interleukin 8, interferon gamma level |
before treatment and at last follow up |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2018 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Allergic conjunctivitis is a perennial ocular allergic disease. It is the inflammatory response of the conjunctiva to allergens such as pollen, animal dander, and other environmental allergens. Allergic conjunctivitis comprises of itching, watering, photophobia, lid oedema, conjunctival hyperaemia and palpebral hypertrophy. Only about 10% of individuals with allergic conjunctivitis seek medical attention, and the entity is often underdiagnosed. Redness and itching are the most consistent symptoms. Seasonal allergic conjunctivitis comprises 90% of all the allergic conjunctivitis cases. Seasonal allergic conjunctivitis (SAC) or hay fever is a common allergic disease typically elicited by airborne allergens such as pollen, grass, weeds and animal dander (Abelson & Schaefer 1993). It is a type 1 hypersensitivity reaction mediated by IgE in response to these environmental antigens. The principal symptom of SAC is ocular itching (Abelson & Schaefer 1993). Other signs and symptoms include conjunctival hyperaemia, tearing, mucus discharge, chemosis and lid oedema. Mast cells play an important role in the pathophysiology of this condition. When specific allergens bind to sensitized mast cells in the conjunctiva, degranulation of mast cells, and release of preformed (histamine, eosinophil chemotactic factor, tryptase) and newly synthesized mediators (prostaglandins, leukotrines) occur. Hence, typical signs and symptoms of SAC appear. Histamine, which is a preformed agent, is accepted as the predominant mediator (Berdy et al. 1991). On the other hand, prostaglandin D2 is produced by the arachidonic acid pathway, and has a role in the pathogenesis of SAC (Woodward et al. 1995). Prostaglandin D2 has been shown to induce conjunctival hyperaemia, oedema and mucus discharge; prostaglandins, particularly D2 and E2, have a pruritogenic effect on the conjunctiva (Woodward et al. 1995). Treatment consists of avoidance of the offending antigen and use of saline solution or artificial tears to physically dilute and remove the allergens. Topical decongestants, antihistamines, mast cell stabilizers, nonsteroidal antiinflammatory drugs, and corticosteroids may be indicated. Topically applied ophthalmic agents are the principal treatment method for SAC. Currently available topical drugs include H1 antihistamines such as levocobastine, H1 antihistamine-vasoconstrictor combinations such as antazoline-naphazoline, mast cell stabilizors such as cromolyn sodium and lodoxamide, and non-steroidal anti-inflammatory drugs (NSAIDs) which inhibit prostaglandin synthesis, such as ketorolac tromethamine. Olopatidine hydrochloride has been indicated for the treatment of the signs and symptoms of allergic conjunctivitis that include itching, redness, tearing, lid swelling, and chemosis. Chronic inflammation is one of the common mechanisms observed in keratoconjunctivitis, caused by the activation of innate immune components, decrease in tear film stability, and increase in tear osmolarity. This imbalance in tear film stability and hyperosmolarity further triggers the release of pro- inflammatory mediators such as interleukin (IL)-1ß, IL-6, tumour necrosis factor (TNF)-a, chemokines, and matrix metalloproteinases from the ocular surface, thus producing an inflammatory environment. In order to break the vicious circle of surface damage and inflammation, anti-inflammatory treatment is required in patients with moderate-to-severe DED. Currently used treatments such as corticosteroids (adverse effects such as glaucoma, infections, and cataracts) and cyclosporine A (efficacy not consistent, stinging sensation) have limitations. Chloroquine is a systemic anti-inflammatory agent used in the treatment of rheumatoid arthritis. It has been investigated for use in dry eyes. Chloroquine has been shown to have anti-inflammatory action in in vitro studies in human corneal epithelial cells. Phase I clinical trials demonstrated safety of chloroquine in healthy volunteers. Phase III clinical trials confirmed the efficacy and safety of chloroquine in subjects with DED. Chloroquine significantly improved the signs and symptoms of dry eye disease. It has been shown to be superior to carboxymethyl cellulose (CMC) in efficacy and to have an early onset of improvement and better tolerance profile compared to cyclosporine A. No serious adverse events were reported in subjects treated with Chloroquine so far. Thus, chloroquine eye drops have proven anti-inflammatory action and therapeutic efficacy which makes it a useful therapeutic option in the management of DED Several studies have reported that use of Chloroquine phosphate drops has improved the sign and symptoms of dry eye and the quality of ocular surface epithelial cells. Thus making Chloroquine drops an important candidate for tear film stability improvement assessment in cases of allergic keratoconjunctivitis. To the best of our knowledge, there are no reports that compare the efficacy of Olopatidine hydrochloride with Chloroquine phosphate in cases of allergic conjunctivitis. The present study is designed to evaluate the efficacy and safety of 0.1% Olopatidine versus combined 0.03% Chloroquine phosphate and 0.1% Olopatidine in allergic conjunctivitis. |