| CTRI Number |
CTRI/2018/10/016170 [Registered on: 26/10/2018] Trial Registered Prospectively |
| Last Modified On: |
25/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study and compare the effects of Alcaftadine 0.25% eyedrops and Olopatadine 0.1% in patients with Allergic conjunctivitis |
|
Scientific Title of Study
|
A Randomized,Open label ,Parallel comparative study of efficacy,safety and tolerability of ophthalmic solutions of Alcaftadine 0.25% and Olopatadine 0.1% in patients with Allergic conjunctivitis in a tertiary care center |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Karthiga |
| Designation |
Principal Investigator |
| Affiliation |
Sri Ramachandra Medical College and Research Institute |
| Address |
Sri Ramachandra Medical College and Research Institute
No 1 Ramachandra Nagar
porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9790953496 |
| Fax |
|
| Email |
karthiga25m@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K PUNNAGAI |
| Designation |
GUIDE |
| Affiliation |
Sri Ramachandra Medical College and Research Institute |
| Address |
Sri Ramachandra Medical College and Research Institute
No 1 Ramachandra Nagar
porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9840574080 |
| Fax |
|
| Email |
punnagaiguna@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Karthiga |
| Designation |
Principal Investigator |
| Affiliation |
Sri Ramachandra Medical College and Research Institute |
| Address |
Sri Ramachandra Medical College and Research Institute
No 1 Ramachandra Nagar
porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9790953496 |
| Fax |
|
| Email |
karthiga25m@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Medical College and Research Institute,Porur ,Chennai - 600116 , Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Dr M Karthiga |
| Address |
Sri Ramachandra Medical College and Research Institute |
| Type of Sponsor |
Other [SELF FUNDING] |
|
|
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 M KARTHIGA |
Sri Ramachandra Hospital |
NO 1 RAMACHANDRA NAGAR
PORUR
CHENNAI 600116
Chennai
TAMIL NADU |
9790953496
karthiga25m@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, SRI RAMACHANDRA UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H101||Acute atopic conjunctivitis, ALLERGIC CONJUNCTIVITIS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ALCAFTADINE 0.25% OPHTHALMIC SOLUTION |
2 DROPS IN AFFECTED EYE ONCE A DAY IN THE MORNING FOR 21 DAYS |
| Comparator Agent |
OLOPATADINE 0.1% OPHTHALMIC SOLUTION |
2 DROPS IN AFFECTED EYE ONCE IN THE MORNING AND ONCE IN THE NIGHT FOR 21 DAYS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)All patients aged > 18 years of both genders clinically diagnosed with allergic conjunctivitis by ophthalmologists.
2)Graded conjunctival redness in at least one region (nasal or temporal) in Eye.
3)Graded ocular itching at any one time point
4)Visual acuity of at least 6/15 in each eye
5)All patients who had an attack history more than 2 years
|
|
| ExclusionCriteria |
| Details |
1)Patients with bacterial, chlamydial, viral and membranous conjunctivitis were excluded
2)Patients with ocular surface disorders like pterygium, dry eye were excluded from the study.
3)Patients who have known hypersensitivity to the drug.
4)History of uveitis, blepharitis, herpes simplex keratitis or herpes zoster keratitis.
5)History of retinal detachment, diabetic retinopathy and progressive retinal disease
6)History of glaucoma, or Intraocular Pressure (IOP) over 25mmHg at the screening visit, or a history of elevated IOP within the past 1 year.
7)Ocular surgery or refractory surgery within 6 months prior to visit 1 or planning to do a surgery during the trial.
8)Use of antibiotics, antivirals, or topical cyclosporine, depot corticosteroids, NSAIDS and other antihistamines or mast cell stabilisers within 1 month of the screening visit.
9)Participants unwilling not to wear contact lenses during the study.
10)Pregnant and lactating women
11)Subjects must not have an ocular itching score >0 or a conjunctival hyperaemia score >1 in either eye in any region (nasal or temporal) at Visit 1.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To compare the improvement in ocular symptoms and signs in patients with Allergic conjunctivitis after the treatment with the study drugs.
2) To compare the reduction in levels of IgE in tear fluid in patients of Allergic Conjunctivitis after the treatment with both the drugs.
|
3 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from baseline in mean of ocular itching and redness as assessed after 30 minutes of instillation of drops
Change from baseline in mean of ocular symptoms and signs on 8th day
Changes in Quality of Life
as measured by Allergic Rhinoconjunctivitis Quality of Life Questionnaire |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
29/10/2018 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, open label, parallel group , active controlled study comparing the safety, efficacy and tolerability of ophthalmic solutions of Alcaftadine 0.25% and Olopatadine 0.1% in patients with Allergic conjunctivitis in a tertiary care The primary outcome measures will be improvement in ocular symptoms and signs and reduction in tear Ig E levels at the end of the 3 weeks.The secondary outcomes will be reduction in ocular symptoms and signs at 8th day and improvement in quality of life at the end of treatment. |