| CTRI Number |
CTRI/2024/08/072453 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Assess the Efficacy and Safety of Cetirizine Ophthalmic Solution |
|
Scientific Title of Study
|
A Prospective, Randomized, Double-blinded, Multi-centric, Two-arm, Parallel-group, Active-Controlled, Phase III Study to Assess the Efficacy
and Safety of Cetirizine Ophthalmic in Patients having ocular itching associated with allergic conjunctivitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol ID: VRL-CT-23-005 Version No: 2.0 dated 13 Jun 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Patil |
| Designation |
Principal Investigator |
| Affiliation |
Belagavi Institute of Medical Science |
| Address |
Belagavi Institute of Medical Science Department of Ophthalmology Dr B R Ambedkar Road Belagavi Karnataka
Belgaum
KARNATAKA
590001
India |
| Phone |
9945447572 |
| Fax |
|
| Email |
drsandeepatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Patil |
| Designation |
Principal Investigator |
| Affiliation |
Belagavi Institute of Medical Science |
| Address |
Belagavi Institute of Medical Science Department of Ophthalmology Dr B R Ambedkar Road Belagavi Karnataka
KARNATAKA
590001
India |
| Phone |
9945447572 |
| Fax |
|
| Email |
drsandeepatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Badrinath Sangle |
| Designation |
Director |
| Affiliation |
Vivotech Research Private Limited |
| Address |
Plot no D17 4 TTC Industrial Area Turbhe MIDC Navi Mumbai 400703 India
Thane
MAHARASHTRA
400703
India |
| Phone |
09930646601 |
| Fax |
|
| Email |
badrinath@vivotechresearch.com |
|
|
Source of Monetary or Material Support
|
| AKUMS DRUGS & PHARMACEUTICALS LTD First floor CT Dept Plot No 131 to 133 Block C Mangolpuri Industrial Area Phase I Adjoining CBSE Office Delhi 110083 India |
|
|
Primary Sponsor
|
| Name |
AKUMS DRUGS PHARMACEUTICALS LTD |
| Address |
Clinical Trial Department Plot No 131 to 133 Block C Mangolpuri Industrial Area Phase I adjoining CBSE Office
Delhi 110083 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AKUMS DRUGS PHARMACEUTICALS LTD |
304, Mohan Place, L.S.C Block C, Saraswati Vihar, Delhi - 110034 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sucheta Parija |
All India Institute of Medical Sciences |
Department of Opthalmology First floor. Sijua, Patrapada, Bhubaneswar-751019, Odisha, India Khordha ORISSA
Khordha
ORISSA |
9437044380
suchetaparija@yahoo.com |
| Dr Sandeep Patil |
Belagavi Institute of Medical Science |
Department of Opthamology Dr B R Ambedkar Road Belagavi 590001 Karnataka
Belgaum
KARNATAKA |
9945447572
drsandeepatil@gmail.com |
| Dr Perwez Khan |
G.S.V.M. Medical College |
Room No 01 Ground Floor Dept of Ophthalmology Swaroop Nagar Kanpur 208002 UP India
Kanpur Nagar
UTTAR PRADESH |
8400331200
drperwezkhan.research@gmail.com |
| Dr Seshu Babu |
Government Medical College & Government General Hospital |
Old RIMSGGH Dept. of Ophthalmology, OPD No:16, 1st Floor, Srikakulam, Andhra Pradesh- 532001, India
Srikakulam
ANDHRA PRADESH |
9493905251
drseshubabupggh@yahoo.com |
| Dr Nitin Kolte |
Imperial Multispecialty Hospital |
Department of Ophthalmology Gate No 1193 Pingle Pride Near Radha Swami Ashram Chikhali Pune 411062
Pune
MAHARASHTRA |
9822653085
imperial.feasibility@gmail.com |
| Dr Aditya Sudhalkar |
Jupiter Hospital & Research Centre |
Department of Ophthalmology Opp. ICAI Bhavan, Sun pharma-Atladara Road, Vadodara- 390012, Gujarat, India
Vadodara
GUJARAT |
9909917561
dradityasudhalkarnm@gmail.com |
| Dr Swati R |
Mysore Medical College and Research Institute K.R. Hospital |
Mysore Medical College and Research Institute
Department of Ophthalmology, K.R. Hospital, Irwin Road, Mysore- 570001
Mysore
KARNATAKA |
9448787598
swatiprakash.darpan@gmail.com |
| Dr Krishnapada Baidya |
NRS Medical College and Hospital |
NRS Medical College and Hospital Dept of Ophthalmology
138, A.J.C. Bose Road, Kolkata- 700014, West Bengal
Kolkata
WEST BENGAL |
9830292615
drkpbaidya@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee G.S.V.M. Medical College |
Approved |
| Ethics Committee Mysore Medical College and Associated Hospital |
Approved |
| Ethics Committee N.R.S. Medical College |
Approved |
| Imperial Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee BIMS |
Approved |
| Jupiter Hospital & Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H108||Other conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm A: Cetirizine Hydrochloride IP (Eq. to Cetirizine 0.24% w/v) |
Arm A: Cetirizine Hydrochloride IP (Eq. to Cetirizine 0.24% w/v). Instill one drop twice daily (approximately 8 hours apart) in each affected eye during entire study duration. Treatment period will be of 2 weeks |
| Comparator Agent |
Arm B: Epinastine HCl (0.05% ) Ophthalmic solution |
Arm B: Epinastine HCl (0.05%) Ophthalmic solution. Instill one drop twice daily (approximately 8 hours apart) in each affected eye during entire study duration. Treatment period will be of 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 Aged between 18 years to 75 years of both gender
2 Patient with signs and symptoms of allergic conjunctivitis diagnosed clinically
3 Subjects must have an ocular itching score 0
4 Patient is willing to give informed consent able to provide availability for the entire study period and follow study protocol |
|
| ExclusionCriteria |
| Details |
Patients with bacterial chlamydial viral and membranous conjunctivitis
Patients with ocular surface disorders like pterygium dry eye were excluded from the study.
Patients with history of uveitis blepharitis herpes simplex keratitis or herpes zoster keratitis.
Patients with history of retinal detachment diabetic retinopathy and progressive retinal disease
Patients with history of glaucoma or Intraocular Pressure over 25mmHg at the screening visit, or a history of elevated IOP within the past 1year.
Patients with ocular surgery or refractory surgery within 6 months prior to visit 1 or planning to do a surgery during the trial.
Patients with use of antibiotics, antivirals, or topical cyclosporine, depot corticosteroids, NSAIDS and other antihistamines or mast cell stabilisers within 1 month of the screening visit.
Patients unwilling not to wear contact lenses during the study.
Pregnant and lactating women
Patient with history of hereditary degenerative retinal disorders eg retinitis pigmentosa or ischemic optic neuropathy including nonarteritic anterior ischemic optic neuropathy
Patient with history of bleeding disorders or significant active peptic ulceration
Patient with history of cancer or undergoing cancer chemo or radiotherapy
Patient having hypersensitivity or any other contraindication to any of the Investigational products including its components; or history of hypersensitivity reaction to sulfa drugs
Patient who have participated in another Investigational study within the 3 months prior to enrolment in this study
Investigator, study personnel, sponsor representatives and their first-degree relatives |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Ocular Itching Severity Score from baseline |
Time frame: Day 1 3rd Minute,
Day 1 5th Minute, Day 1 7th Minute, Day 2, Day 7 and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of participants with treatment-emergent adverse events (TEAEs) reported during the study |
Time frame: Screening, Day 2, Day 7 & Day 14 |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/08/2024 |
| Date of Study Completion (India) |
Date Missing |
| 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)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This will be a Prospective, Randomized, Double-blinded, Multi-centric, Two-arm, Parallel group, Active-Controlled, Phase III Study. The study will be conducted at approximately 06-08 centers in India, having qualified Investigators. The study will be initiated only after the receipt of regulatory and EC approval. Adult subjects between 18 to 75 years of age, who are suffering from with allergic conjunctivitis are eligible for this study. Total 230 subjects suffering from above indication will be randomized to any of the two treatment arms. Efficacy Parameters: Change in Ocular Itching Severity Score from baseline. Change in Conjunctival Hyperemia Grade from baseline. Safety Parameters: Proportion of participants with treatment-emergent adverse events (TEAEs) reported during the study |