| CTRI Number |
CTRI/2018/03/012788 [Registered on: 23/03/2018] Trial Registered Prospectively |
| Last Modified On: |
19/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
An obsevational study to compare the effects of anti allergic eyedrops in patients of allergic conjunctivitis. |
|
Scientific Title of Study
|
An observational analysis of clinical outcomes in patients of vernal keratoconjunctivitis treated with dual acting antihistamines and mast cell stabilisers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Preeti Yadav |
| Designation |
junior resident(Academics) |
| Affiliation |
Aiims Rishikesh |
| Address |
Department of Ophthalmology
Aiims rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9643348447 |
| Fax |
|
| Email |
jyotiy1102@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAjai Agrawal |
| Designation |
Additional Professor |
| Affiliation |
Aiims Rishikesh |
| Address |
Department of Ophthalmology
Aiims rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8607593922 |
| Fax |
|
| Email |
ajaiagrawal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Yadav |
| Designation |
junior resident(Academics) |
| Affiliation |
Aiims Rishikesh |
| Address |
Department of Ophthalmology
Aiims rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9643348447 |
| Fax |
|
| Email |
jyotiy1102@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences
Virbhadra Road,Rishikesh
Uttarakhand-249203,India.
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical SciencesRishikesh |
| Address |
All India Institute of Medical Sciences
Virbhadra Road,Rishikesh
Uttarakhand-249203,India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrPreeti yadav |
Aiims Rishikesh |
2nd floor,Block C2,Ophthalmology OPD,Aiims Rishikesh.
Dehradun
UTTARANCHAL |
9643348447
jyotiy1102@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,aiims rishikesh,uttaranchal. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H108||Other conjunctivitis, vernal keratoconjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
it is an observational study in which patients of vernal keratoconjunctivitis treated with dual acting antihistamines and mast cell stabilisers will be analysed for clinical outcomes in form of signs and symptom resolution of vernal keratoconjunctivitis. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients with a clinical diagnosis of vernal keratoconjunctivitis.
patients of either gender > 5 years.
patients should be willing to consent for all required study visits and follow instructions from study investigators. |
|
| ExclusionCriteria |
| Details |
Patients who are in active stage of any other ocular inflammatory disease besides VKC
Presence of glaucoma, uveitis.
Patients on any oral or topical steroids.
Pregnant or lactating women.
Presence of systemic diseases other than co existing allergic rhinitis, asthma and atopic dermatitis
Any documented H/O hypersensitivity to the said drugs.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Resolution of signs and symptoms in patients of vernal keratoconjunctivitis treated with dual acting antihistamines and mast cell stabilisers. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Resolution of signs and symptoms in patients of vernal keratoconjunctivitis treated with dual acting antihistamines and mast cell stabilisers. |
2 Weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/04/2018 |
| Date of Study Completion (India) |
31/07/2019 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Patients of vernal keratoconjunctivitis on their 1st visit(baseline,day 0) will be asked to sign the informed consent.Demographic information,clinical history &specific symptoms will be noted down.A complete ophthalmic evaluation comprising visual acuity(snellen chart),Slit lamp biomicroscopy, intra ocular pressure (IOP) and fundoscopy under pupillary dilatation will be done.. Patients fulfilling eligibility criteria will be included in the study.Patients on their first visit (DAY 0) will be examined and all the symptoms and signs will be recorded on the proforma. All the above parameters will be reassessed on Day 14(visit 2) and Day 28(visit 3) after treatment with dual acting antihistamines and mast cell stabilisers. All these visits are as per standard of care of the patient. |