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

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 .

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.

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