CTRI/2023/01/049169 [Registered on: 24/01/2023] Trial Registered Prospectively
Last Modified On:
16/06/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
Evaluation of safety and effectiveness of Atropine ophthalmic solution in children with progressive Myopia
Scientific Title of Study
A Multi-Center, Single Arm, Phase IV Study to Assess the Safety and Efficacy of Atropine Ophthalmic Solution to Control the Progression of Myopia in Children of 5 Years and Above
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
Protocol No.: ICR/21/002 Version: 1.0 Date: 23 Mar 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Vice President - Global Clinical Operations
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
9879590828
Fax
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Deshna Lad
Designation
Assistant manager - Medical services- Clinical Trials
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
9409201420
Fax
Email
dlad@cliantha.com
Details of Contact Person Public Query
Name
Mr Devesh Verma
Designation
Associate Director-I
Affiliation
Cliantha Research Limited
Address
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
9712908404
Fax
Email
dverma@cliantha.com
Source of Monetary or Material Support
Sun Pharma Laboratory Limited (SPLL), Mumbai
Primary Sponsor
Name
Sun Pharma Laboratory Limited ( SPLL)
Address
Sun House, Plot No. 201, B/1, Western Highway, Goregoan (E), Mumbai 400063, Maharashtra, India.
L.G.Hospital Campus, Near Rambaug fire station, opposite adani Petrol Pump, Near Krishna Baug, Maninagar 380008, Ahmedabad, Gujarat, India Ahmadabad GUJARAT
9879558775
anupamajgosai@gmail.com
Dr Parth Rana
Netralaya Super Speciality Eye Hospital
1st floor, KayDee House, Above Union Bank of India, Opp. Gujarat Gas, Parimal Garden Cross Road, Ahmedabad-380006, Gujarat, India Ahmadabad GUJARAT
7999999344
Dr.parth.rana@gmail.com
Dr Rupali Maheshgauri
PCMC’s PGI Yashwantrao Chavan Memorial Hospital
2nd floor ophthalmology department, Sant Tukaram Nagar, Pimpri, Pune- 411018 Pune MAHARASHTRA
9561084723
rupalim021@gmail.com
Dr Barot Rakesh K
Rajiv Gandhi Medical College & Chhatrapati Shivaji Maharaj Hospital
Room No. 22, Department of Ophthalmology, Ground Floor, Old Thane-Belapur Road, Kalwa, Thane- 400605 Thane MAHARASHTRA
9820545386
rakeshbarot47@gmail.com
DrLakshmikanta Mondal
Regional Institute of ophthalmology
88. College Street, Kolkata - 700073, West Bengal Kolkata WEST BENGAL
9830830216
lakshmi.mondal62@gmail.com
Dr Ankit Shah
Shree Padmavati Eye Hospital
1st floor, Jalaram Complex, Near ST Stand, Himmatnagar, Gujarat - 383001, India Sabar Kantha GUJARAT
Ethics Committee S.M.S. Medical College and Attached Hospitals
Approved
Health Point Ethics Committee
Approved
IEC OF B.J .G.M. C AND SASSOON GENERAL HOSPITAL
Approved
IEC-MMC and RI and Associated Hospital
Approved
IEC-Regional Institute of ophthalmology
Approved
Institutional Clinical Ethics Committee RGMC and Chatrapati Shivaji Maharaj Hospital
Approved
Institutional Ethics Committee of Diabetes Care Foundation
Approved
Institutional Ethics committee, B.J. Medical College & Civil hospital
Approved
Institutional Ethics Committee, NHLIEC
Approved
Institutional Ethics Committee, S.C.B. Medical College and Hospital
Submittted/Under Review
J.K. Orthopaedic Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: H521||Myopia,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Atropine (0.01%) ophthalmic solution
The recommended dosage is one drop in each eye once daily in the night time for 12 months.
Dose: 1 Drop
Route of administration: Topical
Frequency: Once Daily
Duration of therapy: 12 Month
Comparator Agent
NA
NA
Inclusion Criteria
Age From
5.00 Year(s)
Age To
14.00 Year(s)
Gender
Both
Details
1) Patients of either gender, aged 5 to 14 years (both inclusive) and ready to give written informed assent to participate in the study and written informed consent from parents of participating child
2) Patients with documented active myopia progression of at least spherical equivalent -0.50 D over the last 12 months as determined or suggested by refractive records or change in lens power
3) Patients with refractive error of spherical equivalent -2.00 D or worse in each eye as measured by cycloplegic autorefraction
4) Patients with a difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D
5) Patients with astigmatism of ≤ -1.50 D as measured by cycloplegic or non-cycloplegic autorefraction
6) Patients with distance vision correctable to logarithm of the minimum angle of resolution (logMAR) 0.2 or better in both eyes using Early Treatment Diabetic Retinopathy study chart (ETDRS) method
7) Patients with normal intraocular pressure of ≤ 21 mmHg
8) Patients with normal ocular health other than myopia in less than 06 months of screening
9) Patients willing and able to tolerate cycloplegia and mydriasis
10) Patients willing to come for regular follow-up for 12 months and follow study procedure
11) Female patients of age ≥ 12 years must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till the last dose of the study medication (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence)
ExclusionCriteria
Details
1) Patients with ocular or systemic diseases which may affect vision or refractive error
2) Patients with any ocular condition wherein topical atropine is contraindicated (e.g. glaucoma or narrow angle glaucoma)
3) Patients with previous or current use of atropine
4) Patients with abnormal binocular function and stereopsis
5) Patients with amblyopia or manifest strabismus, including intermittent tropia
6) Patients with history or planning to undergo any ocular surgery
7) Patients who are on treatment of monoamine oxidase inhibitors (MAOI) or planning to take during study period
8) Patients who are hypersensitive to atropine, cyclopentolate, or any other cycloplegic agents including its components
9) Patients with any other conditions precluding adherence to the protocol including unwillingness to refrain from contact lens wear for the duration of the study
10) Participation in any investigational study within 30 days prior to screening
11) Pregnant or lactating female patients
12) Patients with any clinically significant lab abnormalities/ condition (e.g. cardiac or respiratory distress) which in the opinion of investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements
13) Employee of the sponsor, investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees of sponsor or the investigator.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Safety:
Proportion of participants with treatment emergent adverse events (TEAEs) (Photophobia and poor near visual acuity) in the study
12 Month
Secondary Outcome
Outcome
TimePoints
A. Efficacy
1. Spherical equivalent refraction (SER) determined by cycloplegic autorefraction from baseline
B. Safety
1. Distance and near best corrected visual acuity (BCVA) from baseline [Time frame: Month 4, Month 8, Month 12]
2. Pupil reactivity and diameter assessment (mesopic & photopic) from baseline
[Time frame: Month 4, Month 8, Month 12]
3. Any other TEAEs [Time frame: 12 months]
4 Month, 8 Month, 12 Month
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
Phase 4
Date of First Enrollment (India)
27/01/2023
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="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
Nill
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a Phase IV, multicenter, single arm study. The study will be
conducted at approximately 10-12 number of centers in India, having qualified
Investigators. The study will be initiated only after the receipt of
regulatory and ethics committee (EC) approval.
Screening period
After obtaining the written informed consent,
patients will be screened by undergoing various assessments as mentioned in
Schedule of Assessment (Appendix I). After confirming the eligibility on
Day 1, patients will be enrolled by allotting the enrolment number.
Patients will be taking Atropine 0.01% ophthalmic solution for 12 months
(Treatment period). During the study, assessments will be performed as
mentioned in Schedule of Assessment (Appendix I).
Treatment Period
Each patient will receive post-enrolment diary to
record the use of study medication and details pertaining to any events.
Patients will use glasses, if needed. Investigator will offer
photochromatic glasses (which darken on exposure to ultraviolet or sunlight)
if patients experience glare or their parents are worried of excessive
light exposure, or progressive glasses (reading add) if patients experience
difficulty with near vision.
The study has following visits:
Visit 1: Screening (Day -7 to -1)
Visit 2: Enrolment Visit (Day 1)
Visit 3: Day 14 ± 2 (Week 2)
Visit 4: Month 4 ± 4 days
Visit 5: Month 8 ± 4 days
Visit 6: Month 12 ± 4 days Early Termination/ End
of Treatment & End of Study visit
Patients will receive diary to record details
about study drug instillation and adverse events.
Patients early terminating from the study will be
completing Visit 06 assessments. Visit 06 will be considered as end of
treatment and end of study day. The safety and efficacy will be assessed
during the study period. For safety endpoint, Day 1 will be considered as a
baseline and for efficacy endpoints, Day 14 will be considered as a
baseline.