Assessing the safety and performance of the eye drops/spray on pediatric population with eye dryness: 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 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.