Trials / Completed
CompletedNCT07422259
Tolerability and Efficacy Study of Reinnerva/Lubristil+G vs Vismed
Tolerability and Efficacy of Reinnerva/Lubristil+G vs Vismed in the Treatment of the Ocular Surface of Patients With Quali-quantitative Alteration of Lacrimal Film of Different Origins
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Medivis SRL · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The clinical investigation #1122 is a Post Market Clinical Follow Up Study on the EC marked medical device Reinnerva/Lubristil +G, sterile eye drops, compared to Vismed medical device, sterile eye drops, to demonstrate the clinical performance and tolerability of Reinnerva/Lubristil +G to stabilize the lacrimal film and improve the ocular surface condition in the cases of quali-quantitative alterations of the tear film .
Detailed description
The study aim was to demonstrate a significant improvement of the ocular surface condition with the use of Reinnerva/Lubristil +G that, based on its formulation: hydrates, stabilizes and protects the ocular surface in all cases of sensations of dryness, burning and ocular fatigue due to qualitative and quantitative alteration of the tear film.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Reinnerva/Lubristil +G sterile eye drops (artificial tears) | 2 drops instilled in 1 eye, 2 times daily, for 60 days |
| DEVICE | Vismed sterile eye drops (artificial tears) | 2 drops instilled in 1 eye, 4 times daily, for 60 days |
Timeline
- Start date
- 2025-06-09
- Primary completion
- 2025-09-03
- Completion
- 2025-09-03
- First posted
- 2026-02-19
- Last updated
- 2026-02-19
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT07422259. Inclusion in this directory is not an endorsement.