| CTRI Number |
CTRI/2026/02/102870 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To study evaluate the Safety, Tolerability and Effect of Atropine Sulfate Ophthalmic Solution USP 0.05 percentage w/v for Controlling Progression of Myopia in Children. |
|
Scientific Title of Study
|
A Multicentric, Open-label, Prospective, Non-comparative, Phase IV Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Atropine Sulfate Ophthalmic Solution USP 0.05 percentage w/v for Controlling Progression of Myopia in Children. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-EPL-004 Version 1.0 Dated- 17 Jul 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit Saxena |
| Designation |
Principal Investigator |
| Affiliation |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences |
| Address |
Department of Ophthalmology, Room No.377,Third floor, Ansari Nagar, New Delhi -110029 (India)
New Delhi
DELHI
110029
India |
| Phone |
9868155230 |
| Fax |
|
| Email |
rohitsaxena80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt Ltd |
| Address |
Biosphere Clinical Research Pvt. Ltd.
SB-02, 03 and 04, Second Floor Highland Corporate Centre, Kapurbawdi Junction, Thane West Maharashtra, India
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt Ltd |
| Address |
Biosphere Clinical Research Pvt. Ltd.
SB-02, 03 and 04, Second Floor Highland Corporate Centre, Kapurbawdi Junction, Thane West Maharashtra, India
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
|
Source of Monetary or Material Support
|
| Entod Pharmaceuticals Ltd.,
Ashirwad building, Opp. Badi Masjid, S V Road, Bandra (W) Mumbai 400050. |
|
|
Primary Sponsor
|
| Name |
Entod Pharmaceuticals Ltd. |
| Address |
Ashirwad building, Opp. Badi Masjid, S V Road, Bandra (W) Mumbai 400050 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hanumant Rangnath Mandlik |
Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital |
Department of Ophthalmology, Sangli-Miraj Road, Sangli- 416416, Maharashtra India
Sangli
MAHARASHTRA |
9975690038
hrmandlik@gmail.com |
| Dr Rohit Saxena |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences |
Department of Ophthalmology, 377, Third Floor, Ansari Nagar, New Delhi -110029 (India)
New Delhi
DELHI |
9868155230
rohitsaxena80@gmail.com |
| Dr Shrubhratha Hegde |
K R Hospital, Mysore Medical College and Research Institute |
Department of Ophthalmology, Irwin Road, Mysuru-570001, Karnataka, India.
Mysore
KARNATAKA |
9900566118
drshubhratha@gmail.com |
| Dr Bhagat Purvi Raj |
M and J Western Regional Institute of Ophthalmology |
B.J. Medical College, Civil Hospital Campus, Asarwa, Ahmedabad-380016, Gujarat, India.
Ahmadabad
GUJARAT |
9825985265
dr.purvibhagat@yahoo.com |
| Dr Deepti Joshi |
M. M. Joshi Eye Institute Pvt. Ltd., Super Speciality Eye Hospital and Research Institute |
Gokul road, Hosur, Hubli-580021
Dharwad
KARNATAKA |
7829909811
deeptisjoshi22@gmail.com |
| Dr Udayaditya Mukhopadhyay |
N.R.S. Medical College and Hospital |
138, Acharya Jagadish Chandra Bose Road Kolkata-700014, West Bengal, India.
Kolkata
WEST BENGAL |
9830211833
udayadityam@yahoo.com |
| Dr Kishore Kumar Tulsidas Pahuja |
Natasha eye care and Research Centre |
Pimple Sadugar, Shiv Sai Lane, Building A, Sai Saheb Society, Opp. Lotus Hospital, Pune- 411027
Pune
MAHARASHTRA |
9890086862
kishorepahuja@gmail.com |
| Dr Kaushik Murali |
Sankara Eye Hospital |
Varthur Main Road, Kundalahalli Gate, Bangalore
Karnataka- 560037, India.
Bangalore
KARNATAKA |
9739000096
kaushik@sankaraeye.com |
| Dr Reema Nangia |
Shri C.H. Nagri Municipal Eye Hospital |
Department of Ophthalmology, Room No. 118, first floor, Ellise Bridge, Ahmedabad- 380006 Gujarat
Ahmadabad
GUJARAT |
9426646742
ravalreema@yahoo.com |
| Dr Mohita Sharma |
Tirupati Eye Centre and Research Institute |
Block-C, 53, Sector-33, Near NTPC Township, Noida - 201301, Uttar Pradesh, India.
Gautam Buddha Nagar
UTTAR PRADESH |
9560889495
drmohita@tirupatieye.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Committee Institutional Review Board Sankara Eye Hospital |
Submittted/Under Review |
| Ethics Committee N.R.S. Medical College, NRS Medical College and Hospital NRS Medical College |
Approved |
| IEC-MMC and RI and Associated Hospital, Mysore Medical College and Research Institute, Mysore Medical College and Research Institute |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee - B. J. Medical College and Civil Hospital B. J. Medical College and Civil Hospital Office of Medical Superintendent Civil Hospital |
Submittted/Under Review |
| Institutional Ethics Committee BVDU Medical College and Hospital |
Approved |
| Institutional Ethics Committee, NHLIEC Smt. NHL Municipal Medical College |
Submittted/Under Review |
| M M Joshi Eye Institute Ethics Committee M. M. Joshi Eye Institute Private Limited |
Approved |
| SKINOVATE INDEPENDENT ETHICS COMMITTEE |
Approved |
| Women Ophthalmologists Society |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Atropine Sulfate Ophthalmic Solution USP 0.05 percentage w/v |
One drop of Atropine Sulfate Ophthalmic Solution USP 0.05 percentage w/v to be administered once a day preferably at night in each eye for 52 weeks. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female child participants of age between Six to Fifteen years (both inclusive).
2. Participants with normal ocular health other than myopia.
3. Participants with refractive error of spherical equivalent (SE) range of minus 0.50 D to minus 6.00 D in both eyes.
4. Participants with Best-corrected distance visual acuity BCDVA 0.20 log MAR or better in both eyes.
5. The Investigator believes that the participant and participant’s parent or Legally Acceptable Representative LAR will comply with the requirements of the protocol.
6. Written assent informed parental consent obtained from the participant and parent/LAR of the participant for participation in the study. |
|
| ExclusionCriteria |
| Details |
1. Participants with a known history of hypersensitivity to the study medications or any of the ingredients of the formulation.
2. Current or previous myopia treatment with non-study atropine, pirenzepine or other topical anti-muscarinic agents.
3. Participants with astigmatism of more than minus 1.5 D in either eye measured by cycloplegic autorefraction.
4. Participants with abnormality of the cornea, lens, central retina, iris or ciliary body.
5. Participants with current or prior history of ocular diseases (e.g., cataract, congenital retinal diseases, amblyopia, and strabismus).
6. Medical conditions predisposing participant to degenerative myopia, abnormal ocular refractive anatomy, and/or history of any other ocular diseases or ocular surgery.
7. Presence of a severe/serious ocular condition or any other unstable medical condition that, in the Investigators opinion, may preclude study treatment or follow-up.
8. Participants with clinically relevant current or past history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal and neurological diseases or any congenital conditions.
9. Suspected inability or unwillingness to comply with the protocol or other study procedures.
10. Participants currently participating in any other clinical trial or has participated in any other clinical trial thirty days prior to screening.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The assessment of the safety of participants Based on the incidence of treatment-emergent adverse event (TEAE).
2. The assessment of the tolerability of the study drug will be based on the incidence of AEs and SAEs.
|
52 Weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in spherical equivalent refractive error from baseline to week 52, measured by cycloplegic autorefraction. |
52 Weeks |
| The proportion of participants showing less than 0.50 D (spherical equivalent) myopia progression compared to baseline measured using cycloplegic autorefraction. |
52 Weeks |
| Mean change in ocular axial length from baseline to week 52. |
52 Weeks |
| Mean change in pupil size from baseline to week 52. |
52 Weeks |
| Mean change in accommodation amplitude (D) from baseline to week 52. |
52 Weeks |
Mean change in visual acuity from baseline to week 52.
|
52 Weeks |
|
|
Target Sample Size
|
Total Sample Size="206"
Sample Size from India="206"
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)
|
19/02/2026 |
| 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) |
Open to Recruitment |
|
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
|
A Multicentric, Open-label, Prospective, Non-comparative, Phase IV Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Atropine Sulfate Ophthalmic Solution USP 0.05 percentage w/v for Controlling Progression of Myopia in Children.
Primary Objective:
To evaluate the safety and tolerability of Atropine Sulfate Ophthalmic Solution USP 0.05 percentage w/v for Controlling Progression of Myopia in Children.
Secondary Objective:
To evaluate the efficacy of Atropine Sulfate Ophthalmic Solution USP 0.05 percentage w/v for Controlling Progression of Myopia in Children. |