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A post-market clinical study to assess the safety and performance of eye drops/spray for treating eye dryness in pediatric populations.

Assessing the safety and performance of the eye drops/spray on pediatric population with eye dryness: A prospective clinical study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/079918
Enrollment
10
Registered
2025-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H53- Visual disturbances

Interventions

Intervention1: 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 o

Sponsors

NOVAX PHARMA S.A.M.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pediatric subjects (6 to 18 years of age) 2. Subjects who experience eye dryness

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 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

MeasureTime frame
The secondary objective will be to assess performance (alleviation of eye dryness) of the product.Timepoint: 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

Countries

India

Contacts

Public ContactDr Suresh S

Nalam Homoeo Clinic & Research Center

drsureshhsr@gmail.com9843872260

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026