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CTRI Number  CTRI/2025/04/085554 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On: 17/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to compare the safety and effectiveness of Menicon Bloom Night lenses with another brand of orthokeratology lenses, and spectacles for myopia control, in Indian children. 
Scientific Title of Study   A prospective, randomized, multicentre, open-label study to evaluate the safety and effectiveness of Menicon Bloom Night lenses compared to an available registered brand of orthokeratology lenses, and spectacles for myopia control, and single vision spectacles in Indian children 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
PRPL_MNN_MD01012025,Version 1.0, Date 02 Apr 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashvin Agarwal 
Designation  Executive Director 
Affiliation  Dr. Agarwals Eye Hospital 
Address  Room no 14 Ground floor Dr Agarwals Eye Hospital ltd Main Hospital No 222 TTK Road Alwarpet

Chennai
TAMIL NADU
600018
India 
Phone  9840430100  
Fax    
Email  agarwal_ashvin@dragarwal.com  
 
Details of Contact Person
Scientific Query  
Name  Hikaru Hirata 
Designation  Clinical Study Lead 
Affiliation  Menicon Co. Ltd. 
Address  Room No. 1, 2nd Floor, International Clinical Department, 21-19, Aoi 3, Naka-ku, Nagoya 460-0006 Japan



460-0006
Other 
Phone  818086516800  
Fax    
Email  h-hirata@menicon.co.jp  
 
Details of Contact Person
Public Query  
Name  Dr Mukul Maurya 
Designation  Director & Founder 
Affiliation  Proclin Research PVT LTD  
Address  Room No 1 2nd floor plot No 1 Near Nevri Hills Gufa Mandir Road Lalghati

Bhopal
MADHYA PRADESH
462030
India 
Phone  7032802286  
Fax    
Email  mukul@proclinresearch.com  
 
Source of Monetary or Material Support  
Menicon Co Ltd 3-21-19 Aoi Naka-ku Nagoya 460-0006 JAPAN  
 
Primary Sponsor  
Name  Menicon Co Ltd 
Address  3-21-19 Aoi Naka-ku Nagoya 460-0006 JAPAN  
Type of Sponsor  Other [Opthalmic- Menicon Co Ltd] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akshya  Dr. Agarwals Eye Hospital  OPD No. 10, 2nd Floor,T.D.K Tower, No 6, Duraiswamy Reddy Street, West Tambaram, Near Tambaram Bus Stop
Chennai
TAMIL NADU 		 9677036360

akshya07med@gmail.com 
Dr Amod Nayak  Dr. Agarwals Eye Hospital   Floor 1, J-103 Esteem Royale Opposite Nirguna Mandir, ST bed layout
Bangalore
KARNATAKA 		 9990473548

doc_amodnayak@yahoo.co.in 
Dr Ashvin Agarwal  Dr. Agarwals Eye Hospital  Room No:14 Ground Floor No.222, TTK Road, Alwarpet, Near Raj Park Hotel, Chennai, Tamil Nadu
Chennai
TAMIL NADU 		 9840430100

agarwal_ashvin@dragarwal.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
IEC Dr Agrawals health Care Chennai  Approved 
Institutional Ethics committee - Dr Agrawal’s Eye Hospital Tambaram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H521||Myopia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Menicon Bloom Night lenses  Menicon Bloom Night™ (MBN) is the first ortho-k lens which is CE-approved specifically for Myopia Control in Europe. It involves the overnight wear of a specially designed orthokeratology contact lens manufactured in hyper oxygen permeable Menicon Z material to ensure optimal corneal oxygenation for safe and comfortable lens wear. The treatment temporarily changes the shape of the cornea by flattening and steepening the central and mid-peripheral corneal curvatures, respectively. These corneal changes occur overnight and reduce refractive error, thus eliminating the need to wear contact lenses throughout the waking hours after lenses are removed.  
Comparator Agent  Paragon CRT orthokeratology lenses   Paragon CRT lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones such as central spherical, Return Zone (mathematically designed sigmoidal corneal proximity) and landing Zone (non-curving). The lens design also includes a convex elliptical edge terminus that smoothly join the anterior and posterior surfaces. Lens material is thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. Paragon CRT Contact Lenses produce a temporary reduction of myopia by changing the shape (flattening) of the cornea, which is elastic in nature.  
Comparator Agent  Single vision spectacles  Single-vision spectacles are designed to correct vision at a single focal distance, meaning the entire lens has a uniform prescription. They are commonly used for individuals with myopia (nearsightedness), hyperopia (farsightedness), or astigmatism.  
Comparator Agent  Zeiss MyoCare spectacles   ZEISS MyoCare is designed for myopia progression management, integrating two key lens design concepts. It features Cylindrical Annular Refractive Elements (C.A.R.E.) Technology, which incorporates optical microstructures that deliver a “stop signal” to slow excessive myopia progression. This patented technology consists of alternating defocus and correction zones that expand towards the lens periphery, ensuring effective myopia control while maintaining wearability. Additionally, spectacle lenses must account for eye movement behind the lens to maintain both intended correction and myopic defocus across all gaze angles. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1.Patients with myopia and myopic astigmatism.
2.Patients aged between above or equal to 6 and under or equal to 15 years old at baseline examination.
3.Keratometry: 37 to 52 D (diopter)
4.Fully understand the purpose of the clinical study and agree to sign the informed consent form to participate in clinical study, based on his/her willingness.
5.Patients who can visit the institution on scheduled dates
6.Patients who can receive guidance and tests as required by
the investigator
7.Patients who fully understand and follow the instructions of the
lenses for this clinical study
 
 
ExclusionCriteria 
Details  1. Best corrected vision acuity of more than 0.1 logMAR (less than 6/7.5 Snellen) with spectacles
2. Subjective refraction test shows spherical power greater than -4.00D, less than -0.50D or astigmatism greater than 1.5D or anisometropia greater than 1.5D.
3. Presence of Strabismus at distance or near
4. Patients in need of treatment for eye disease other than refractive error (excluding those receiving artificial tears eye drops due to the wearing of corneal contact lenses)
5. The medical history of intraocular surgery that may affect the effect of wearing orthokeratology lenses (those with corneal transplantation, retinal detachment, etc.)
6. The medical history of refractive corneal surgery
7. Having eye allergic diseases that may cause disorders in wearing orthokeratology lenses
8. All corneal abnormalities including keratoconus, corneal dystrophy, previous history of ocular herpes infections, low corneal endothelial cell counts
9. Patients who are participating in other clinical studies or have participated in other clinical studies in the past 30 days
10. Prior experience with use of rigid lenses within the previous 3 weeks or use of soft lenses within the previous 3 days
11. Prior history of myopia control treatment within 06 months (e.g. atropine, orthokeratology, multifocal soft contact lenses, spectacles designed for myopia control, red light therapy)
12. Deemed inappropriate for participation in this study by an ophthalmologist after detailed eye health check





 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary effectiveness endpoints:
1. Axial elongation (for Myopia control efficacy): [Timeframe:
Screening, month 03, 06 and 12]
2. Visual acuity (for Myopia correction efficacy): [Timeframe: Screening, week 03, month 03, 06 and 12]
3. Cycloplegic Refraction(for Myopia correction efficacy): [Timeframe: Screening, month 06 and 12]
4. Slit lamp findings (for Safety): [Timeframe: Screening, week 03, month 03, 06 and 12]
5. IOP (for Safety): [Timeframe: Screening, month 12]
6. Corneal endothelial cell (for Safety): [Timeframe: Screening,month 12]
7. Central corneal thickness (for Safety): [Timeframe: Screening, month 12]
8. Adverse Event Monitoring (for Safety): [Timeframe: Screening, lens allocation, day 01, week 01 and 03, Month 03, 06 and 12 		 Primary effectiveness endpoints:
1. Axial elongation (for Myopia control efficacy): [Timeframe:
Screening, month 03, 06 and 12]
2. Visual acuity (for Myopia correction efficacy): [Timeframe: Screening, week 03, month 03, 06 and 12]
3. Cycloplegic Refraction(for Myopia correction efficacy): [Timeframe: Screening, month 06 and 12]
4. Slit lamp findings (for Safety): [Timeframe: Screening, week 03, month 03, 06 and 12]
5. IOP (for Safety): [Timeframe: Screening, month 12]
6. Corneal endothelial cell (for Safety): [Timeframe: Screening, month 12]
7. Central corneal thickness (for Safety): [Timeframe: Screening, month 12]
8. Adverse Event Monitoring (for Safety): [Timeframe: Screening, lens allocation, day 01, week 01 and 03, Month 03, 06 and 12

 
 
Secondary Outcome  
Outcome  TimePoints 
1. Corneal Topography (Test group & Control group1)
2. Corneal endothelial cell (for Safety) (Test group & Control group1)
3. Central corneal thickness (for Safety) (Test group & Control group1)
4. Lens condition (for Test group & Control group1) Lens inspection with slit lamp
5. Satisfaction Questionnaire for Patients & Parents
6. Satisfaction Questionnaire for ECP
7. Adherence/Compliance Questionnaire for all group (Wearing time monitoring)  		 1. Screening, day01, week 01 & 03, month 03, 06 & 12
2. Screening, month 06
3. Screening, month 06
4. Day 01, week 01 & 03, Month 03, 06 & 12
5. Week 03, month 06 & 12
6. Screening & month 12
7. Week 03, Month 06 & 12 
8. Spectacle Wearing time (Eye Care clip) (for Control group 2 and
3)  		 Week 03, Month 06 & 12 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   05/05/2025 
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 Yet Recruiting 
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  

Myopia is one of the most common refractive errors and a major cause of vision impairment worldwide. While Menicon  Bloom Night™ lenses have shown effectiveness in controlling myopia progression globally, clinical data in the Indian pediatric population remains limited. Given the rising prevalence of myopia in India, especially among school-going children, evaluating MBN’s safety and efficacy compared to existing myopia control methods (registered Ortho-K lenses, myopia control spectacles, and single vision spectacles) is crucial for evidence-based recommendations.

Therefore, this study is designed to investigate the safety and the effectiveness for myopia correction and myopia control of Menicon Bloom Night lenses compared to an available registered brand of orthokeratology lenses, myopia control spectacles, and single vision spectacles in Indian children for academic and marketing purpose.


 
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