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CTRI Number  CTRI/2025/02/080344 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 11/09/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   A post market clinical study to assess the safety and performance of the eye drops/spray for treating eye redness and eye irritation in pediatric population  
Scientific Title of Study   Assessing the safety and performance of the eye drops/spray on pediatric population with eye redness and eye irritation: A prospective clinical study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MOD 7.3.18b [Dated: 09-Jan-2025] [Rev.: 01]   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suresh S 
Designation  General Physician  
Affiliation  Nalam Homoeo Clinic & Research Center 
Address  Homeopathy Department Division: Research Center Ground Floor, Room 01 HIG 221, Old ASTC Hudco, Hosur

Dharmapuri
TAMIL NADU
635109
India 
Phone  9843872260  
Fax    
Email  drsureshhsr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suresh S 
Designation  General Physician  
Affiliation  Nalam Homoeo Clinic & Research Center 
Address  Homeopathy Department Division: Research Center Ground Floor, Room 01 HIG 221, Old ASTC Hudco, Hosur


TAMIL NADU
635109
India 
Phone  9843872260  
Fax    
Email  drsureshhsr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suresh S 
Designation  General Physician  
Affiliation  Nalam Homoeo Clinic & Research Center 
Address  Homeopathy Department Division: Research Center Ground Floor, Room 01 HIG 221, Old ASTC Hudco, Hosur


TAMIL NADU
635109
India 
Phone  9843872260  
Fax    
Email  drsureshhsr@gmail.com  
 
Source of Monetary or Material Support  
NOVAX PHARMA S.A.M. Le Coronado 20, Avenue de Fontvieille, MC 98000 MONACO  
 
Primary Sponsor  
Name  NOVAX PHARMA S.A.M.  
Address  Le Coronado 20, Avenue de Fontvieille, MC 98000 MONACO  
Type of Sponsor  Other [Medical device company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suresh S  Nalam Homoeo Clinic & Research Center  Ground Floor, Room: 01 HIG 221, Old ASTC Hudco, Hosur, Tamilnadu 635109
Dharmapuri
TAMIL NADU 		 9843872260

drsureshhsr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H53||Visual disturbances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Flora Vision Irritated Eyes drops/spray 2. Flora Vision Red Eyes drops/spray  1. Flora Vision Irritated Eyes drops/spray - It helps fight symptoms of minor allergies due to pollen, mould spores, dust, smog and other eye irritations. It brings quick and long-lasting relief in case of irritated eyes caused by pathological or non-pathological conditions associated with external factors such as prolonged exposure to video screens and monitors, air conditioning, dust, pollution smoke, sunlight. The duration of study is 1 month. Subjects will be followed up 3 times on Day 2, Day 7 and Day 30 after using the product. 2. Flora Vision Red Eyes drops/spray - It helps relieve the condition of red and tired eye associated with conjunctivitis-like symptoms such as itching, burning and irritation caused by exposure to sunlight, wind and pollution. It helps support the physiological and natural defenses of the ocular and lachrymal systems. The duration of study is 1 month. Subjects will be followed up 3 times on Day 2, Day 7 and Day 30 after using the product. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Pediatric subjects (6 to 18 years of age)
2. Subjects who experience eye irritation, eye redness  
 
ExclusionCriteria 
Details  1. Anyone with known allergic reaction to the ingredients of the
eye drops/spray
2. Subjects with existing eye infection
3. History of ocular surgery
4. History or active signs of severe or serious ocular conditions
such as inflammatory corneal ulcers, recurrent erosions, and
uveitis at any time
5. Subjects participating in any another clinical trial during
study
6. Subjects without written consent to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary objective of this study is to evaluate the safety (observation of complications, side effects or risks affecting vision) of the product from the baseline with follow up visits.   There will be 3 follow up visits expected after using the product:
1st Visit – Day 2 of product usage
2nd Visit – Day 7 of product usage
3rd Visit – Day 30 of product usage 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary objective will be to assess performance (alleviation of eye irritation and eye redness) of the product.   There will be 3 follow up visits expected after using the product:
1st Visit – Day 2 of product usage
2nd Visit – Day 7 of product usage
3rd Visit – Day 30 of product usage 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   22/02/2025 
Date of Study Completion (India) 13/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 study is designed as a prospective, interventional, multicentric, non-randomized, open-label, single-arm clinical study.

The subjects visiting the study centre with symptoms of eye irritation and eye redness will be screened on Day 0. Each subject who meets the inclusion and exclusion criteria, will take part in the clinical study from the time the legal representative signs the ICF. 

A total of 20 subjects (10 for each indication) will be recruited. Each subject will undergo visual acuity test, eye examinations and will receive eye drops/spray as determined by the Principal Investigator. They will be followed up 3 times on Day 2, Day 7 and Day 30 after using the product. At every follow up visit, eye examinations will be performed by the Investigator and all clinical findings are recorded. 

In addition to the tests, any complications, side effects, and risks will be recorded in the Case Report Forms (CRF). The adapted Erythema, Edema, and Sensation (EES) Scale for the eye will be used to assess ocular reactions, facilitating both clinical evaluation and continuous patient monitoring. A separate section will be included for the subject to provide feedback on their experience with the product. 

The primary objective of this study is to determine the clinical safety of the product from the baseline with follow up visits. The secondary objective is to assess the performance of the product in alleviating the eye irritation and redness. Also, the additional clinical benefits of using the product will be noted.

Results-
In the irritated eyes group, 70% were male and the age distribution was evenly split between 6–11 and 12–18 years. Subjects used either FLORA VISION® KIDS IRRITATED EYES DROPS (4 subjects) or SPRAY (6 subjects). Most of the subjects experienced symptoms relief by Day 2, and all reported complete resolution by Day 30. Visual acuity remained stable throughout the study, and EES scale scores improved from Grades 1 - 3 to Grade 0. No adverse events or complications were observed. Product usage decreased from 3 - 4 times/day to twice daily by Day 30, with the duration of relief extending to 5 - 8 hours. All subjects were satisfied with the product’s ease of use and effectiveness, and investigators consistently rated performance as “Excellent.” 

In the red eyes group, 60% were male, with a majority in the 6 - 11 age group. Four subjects used FLORA VISION® KIDS RED EYES DROPS and six used the SPRAY. All 10 subjects reported symptom improvement and all achieved complete relief by Day 30. Visual acuity

remained unaffected, and the EES scale improved from Grades 2 - 3 to Grade 0. No adverse effects or complications were reported. Usage frequency also declined to two times per day, by Day 30, with relief lasting 5 - 8 hours. Subject satisfaction was high, and investigator assessments were positive, with only one subject rated as “Good” on Day 2 and all others rated “Excellent.”
Overall, both formulations demonstrated strong clinical performance, safety, and patient satisfaction, supporting their use in paediatric populations for the treatment of irritated and red eyes.

 
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