Keratoconjunctivitis SiccaNCT07422259
Tolerability and Efficacy Study of Reinnerva/Lubristil+G vs Vismed
A study testing Reinnerva/Lubristil +G sterile eye drops (artificial tears) and Vismed sterile eye drops (artificial tears) in people with Keratoconjunctivitis Sicca, run by Medivis SRL at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Keratoconjunctivitis Sicca
- What is being tested?
- Reinnerva/Lubristil +G sterile eye drops (artificial tears) and Vismed sterile eye drops (artificial tears)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jun 2025to 3 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read the 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
- Keratoconjunctivitis Sicca
- Being tested
- Reinnerva/Lubristil +G sterile eye drops (artificial tears), Vismed sterile eye drops (artificial tears)
- Medical subject headings
- Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinnerva/Lubristil +G sterile eye drops (artificial tears)Device
2 drops instilled in 1 eye, 2 times daily, for 60 days
Vismed sterile eye drops (artificial tears)Device
2 drops instilled in 1 eye, 4 times daily, for 60 days
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Device: Reinnerva/Lubristil +G sterile eye drops (artificial tears) |
| 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 . Receives: Device: Vismed sterile eye drops (artificial tears) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From enrollment to the end of treatment at 30 and 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start9 Jun 2025
- Primary completion3 Sep 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconjunctivitis SiccaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medivis SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Messina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422259
- Sponsor's protocol ID
- #1122
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared for privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07422259
- Acronym / sponsor ID
- #1122
- Conditions
- Keratoconjunctivitis Sicca
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medivis SRLIndustry (pharma, biotech, devices)
- Collaborators
- University of Messina
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Reinnerva/Lubristil +G | Experimental | Device: Reinnerva/Lubristil +G sterile eye drops (artificial tears)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 | Device: Vismed sterile eye drops (artificial tears)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 . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reinnerva/Lubristil +G sterile eye drops (artificial tears)2 drops instilled in 1 eye, 2 times daily, for 60 days | Device | Reinnerva/Lubristil +G |
| Vismed sterile eye drops (artificial tears)2 drops instilled in 1 eye, 4 times daily, for 60 days | Device | Vismed |
Primary outcome
Clinical Performance and Benefit
Time frame: 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
Clinical Performance and Benefit
Time frame: 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 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.
Clinical Performance and Benefit
Time frame: 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 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.
Clinical Performance and Benefit
Time frame: 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 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.
Clinical Performance and Benefit
Time frame: 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 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.
Safety/Tolerability
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No. IPD will not be shared for privacy and confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reinnerva/Lubristil +G sterile eye drops (artificial tears) and Vismed sterile eye drops (artificial tears) in people with Keratoconjunctivitis Sicca, run by Medivis SRL at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Performance and Benefit (time frame: From enrollment to the end of treatment at 30 and 60 days.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.