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CTRI Number  CTRI/2025/02/079918 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On: 11/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
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 eye drops/spray for treating eye dryness in pediatric populations. 
Scientific Title of Study   Assessing the safety and performance of the eye drops/spray on pediatric population with eye dryness: A prospective clinical study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MOD 7.3.18a  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

Dharmapuri
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

Dharmapuri
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  Flora Vision Dry Eyes drops/Spray  It helps to sustain the physiological conditions of the ocular surface and lachrymal system. It brings quick and lasting relief in case of sensation of dry eyes caused by pathological or non-pathological conditions associated with external factors such as prolonged exposure to video screens, monitors, air conditioning, dust, pollution smoke and sunlight. The total duration of this intervention is 2 months. Subjects will be followed up 4 times on Day 7, Day 15, Day 30 and Day 60 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 dryness 
 
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 4 follow up visits expected after using the product:
1st Visit – Day 7 of product usage
2nd Visit – Day 15 of product usage
3rd Visit – Day 30 of product usage
4th Visit – Day 60 of product usage 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary objective will be to assess performance (alleviation of eye dryness) of the product.  There will be 4 follow up visits expected after using the product:
1st Visit – Day 7 of product usage
2nd Visit – Day 15 of product usage
3rd Visit – Day 30 of product usage
4th Visit – Day 60 of product usage 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   11/02/2025 
Date of Study Completion (India) 30/04/2021 
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 dryness 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 10 subjects will be recruited. Each subject will undergo visual acuity test, Schirmer’s test, TBUT, eye examinations and will receive eye drops/spray from the Investigator. They will be followed up 4 times on Day 7, Day 15, Day 30 and Day 60 after using the product. At every follow up visit, tests and 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 Symptom Assessment iN Dry Eye (SANDE) questionnaire for the eye will be used to assess symptoms of ocular dryness, 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 dryness. Also, the additional clinical benefits of using the product will be noted.

Results-
In the study group, 60% were male and the age distribution was split between years (6 subjects) and 12–18 years (4 subjects). Subjects used either FLORA VISION® KIDS DRY EYES DROPS (8 subjects) or SPRAY (2 subjects). Most experienced symptom relief by Day 7, and all reported complete resolution by Day 60. Visual acuity remained stable throughout the study, and SANDE scale scores showed symptom resolution from scores moderate to severe at baseline to low scores by Day 60. 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.” 

Overall, the formulation demonstrated strong clinical performance, safety, and patient satisfaction, supporting their use in paediatric populations for the treatment of dry eyes. 


 
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