Keratoconjunctivitis Sicca
Conditions
Brief 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.
Interventions
DEVICEReinnerva/Lubristil +G sterile eye drops (artificial tears)
2 drops instilled in 1 eye, 2 times daily, for 60 days
DEVICEVismed sterile eye drops (artificial tears)
2 drops instilled in 1 eye, 4 times daily, for 60 days
Sponsors
Medivis SRL
University of Messina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Study prospective, interventional, single-blind (assessor-blinded), controlled, of superiority vs a commercial medical device, randomized, and conducted in a single clinical site.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Performance and Benefit | From enrollment to the end of treatment at 30 and 60 days. | Demonstrate the ability of Reinnerva/Lubristil + G to significantly improve the condition of the ocular surface assessed through subjective symptomatology expressed according to SANDE. The efficacy analysis has been evaluated by: \- Change in symptoms measured by a questionnaire (SANDE - Symptom Assessment in Dry Eye) to assess patient well-being. Unit of Measure: The SANDE is based on a visual analog scale (VAS). The patient answers only two questions regarding the frequency and severity of symptoms. For each question, a 100-millimeter horizontal line is provided: Symptom Frequency: From "Rarely" (0 mm) to "All the Time" (100 mm). Symptom Severity: From "Very Mild" (0 mm) to "Very Severe" (100 mm). The final measurement (Final Score) is a numerical value between 0 and 100. The total score is obtained by calculating the square root of the product of the two scales. Parameters have been evaluated at the following times: T0 - screening, T30 - day 30 ± 3 days, T60 - day 60 ± 3 days |
| Safety/Tolerability | From enrollment to the end of treatment at 30 and 60 days. | Adverse Events (AEs): Information regarding any medical device (eye drops) defect or event reported by a patient or investigator has been monitored at each investigational visit. Safety and tolerability analyses have included the number of adverse events occurred during the study in the treatment group and the percentage of patients with at least one adverse event judged to be related to the medical device under study |
Countries
Italy
Outcome results
None listed