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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
 
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.

 
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