Assessing the safety and performance of the eye drops/spray on pediatric population with eye redness and eye irritation: A prospective clinical study

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.