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| Name | Class |
|---|---|
| University of Messina | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reinnerva/Lubristil +G | Experimental | 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 . |
|
| Vismed | Active Comparator | 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 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reinnerva/Lubristil +G sterile eye drops (artificial tears) | Device | 2 drops instilled in 1 eye, 2 times daily, for 60 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Performance and Benefit | 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 | From enrollment to the end of treatment at 30 and 60 days. |
| Clinical Performance and Benefit | Demonstrate the ability of Reinnerva/Lubristil + G to significantly improve the condition of the ocular surface assessed through the Schirmer test. The efficacy analysis has been evaluated by: - Schirmer test I (without anesthesia)- quantitative parameter Unit of Measure: The Schirmer test measures tear production in millimeters (mm) of strip wetting over a set time, typically 5 minutes. Results indicate the length of the moisture strip, with ≤ 5 mm in 5 minutes indicating severe dry eye, while >15 mm is considered normal. Parameters have been evaluated at the following times: T0 - screening, T30 - day 30 ± 3 days, T60 - day 60 ± 3 days. | From enrollment to the end of treatment at 30 and 60 days. |
| Clinical Performance and Benefit | Demonstrate the ability of Reinnerva/Lubristil + G to significantly improve the condition of the ocular surface assessed through the NIK-BUT and BUT. The efficacy analysis has been evaluated by: Non-Invasive Keratograph Break-Up Time (NIKBUT)and BUT, objective, automated metric used in eye care to assess tear film stability. Unit of measure of NIKBUT: seconds (s). Normal tear film stability usually results in longer NIKBUT values, often exceeding 10 seconds, while dry eye conditions typically present with shorter, faster break-up times. Unit of measure of BUT: seconds (s). Normal result typically greater than 10 seconds, while values below 10 seconds (or especially under 5 seconds) indicate unstable, evaporative dry eye. Parameters have been evaluated at the following times: T0 - screening, T30 - day 30 ± 3 days, T60 - day 60 ± 3 days. |
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Inclusion Criteria:
Patients receiving chronic therapy with antihypertensive eye drops; Patients receiving post-ocular surgery therapy for at least 15 days
Schirmer's test (8 mm lower in 5 minutes) BUT (Burning Time) less than 10 seconds Fluorescein Infection Infection (NEI) score ≥3
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOC of Ophthalmology, AOU Policlinico "G. Martino" | Messina | 98125 | Italy |
IPD will not be shared for privacy and confidentiality.
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| ID | Term |
|---|---|
| D007638 | Keratoconjunctivitis Sicca |
| ID | Term |
|---|---|
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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Study prospective, interventional, single-blind (assessor-blinded), controlled, of superiority vs a commercial medical device, randomized, and conducted in a single clinical site.
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| Vismed sterile eye drops (artificial tears) | Device | 2 drops instilled in 1 eye, 4 times daily, for 60 days |
|
| From enrollment to the end of treatment at 30 and 60 days. |
| Clinical Performance and Benefit | Demonstrate the ability of Reinnerva/Lubristil + G to significantly improve the condition of the ocular surface assessed through Tear meniscus thickness by keratography. The efficacy analysis has been evaluated by: - Tear meniscus thickness by keratograph- quantitative parameter Unit of Measure: Tear meniscus height (TMH) measured by the Oculus Keratograph 5M (K5M) is reported in millimeters (mm), with normal values typically ranging between 0.2 mm and 0.4 mm. Parameters have been evaluated at the following times: T0 - screening, T30 - day 30 ± 3 days, T60 - day 60 ± 3 days. | From enrollment to the end of treatment at 30 and 60 days. |
| Clinical Performance and Benefit | Demonstrate the ability of Reinnerva/Lubristil + G to significantly improve the condition of the ocular surface assessed through fluorescein staining and its change between baseline and after 1-2 months of treatment . The efficacy analysis has been evaluated by: - Fluorescein staining (NEI scheme - National Eye Institute Industry Workshop)/Corneal/Conjunctival evaluation with fluorescein - ordinal parameter. Unit of Measure: Subjective, graded scoring systems to assess corneal epithelial damage. The most common unit of measure is the NEI (National Eye Institute) Scale, a 0 to 3 scale for each of the five corneal regions (central, superior, inferior, nasal, temporal), with 0 = no stain and 3 = severe staining in each of 5 areas, based on staining density and location, totaling 0-15 point scale. Parameters have been evaluated at the following times: T0 - screening, T30 - day 30 ± 3 days, T60 - day 60 ± 3 days. | From enrollment to the end of treatment at 30 and 60 days. |
| Safety/Tolerability | 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 | From enrollment to the end of treatment at 30 and 60 days. |
| D007634 |
| Keratitis |
| D003316 | Corneal Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |