Tolerability and Efficacy Study of Reinnerva/Lubristil+G vs Vismed

Medivis SRL

Status: Completed

Conditions: Keratoconjunctivitis Sicca

Treatments: Device: Vismed sterile eye drops (artificial tears); Device: Reinnerva/Lubristil +G sterile eye drops (artificial tears)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07422259

#1122

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Male and female, aged 18 to 80 years
• Alteration of the tear film or bilateral ocular surface discomfort resulting from one of the following conditions:

Patients receiving chronic therapy with antihypertensive eye drops; Patients receiving post-ocular surgery therapy for at least 15 days

• At least two of the following symptoms of dry eye: burning, stinging, dry eye sensation, foreign body sensation, photophobia
• At least two of the following:

Schirmer's test (8 mm lower in 5 minutes) BUT (Burning Time) less than 10 seconds Fluorescein Infection Infection (NEI) score ≥3

Exclusion criteria

• Active keratitis caused by herpes simplex, vaccinia virus, varicella-zoster, and other viral infections of the cornea and conjunctiva
• Current bacterial, fungal, and tuberculosis infections
• Corneal stromal perforations and ulcers
• Hypersensitivity to any of the product components
• Current ocular allergy or allergic rhinitis
• Participation in a clinical trial in the month prior to the start of the study
• Systemic anti-acne therapy in the 6 months prior to the start of the study
• Any change in systemic therapy in the month prior to the start of the study
• Contact lens use in the week prior to the start of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Reinnerva/Lubristil +G

Experimental group

Description:

25 patients (17 of these participants were post-surgical and 8 glacomatous) received Reinnerva/Lubristil +G, sterile eye drops, 2 drops in 1 eye, twice daily for 60 days .

Treatment:

Device: Reinnerva/Lubristil +G sterile eye drops (artificial tears)

Vismed

Active Comparator group

Description:

15 patients (11 of these participants were post-surgical and 4 glacomatous) received Vismed, sterile eye drops, 2 drops in 1 eye, 4 times daily for 60 days .

Treatment:

Device: Vismed sterile eye drops (artificial tears)