Dry Eye SyndromesPROSIKANCT04701086
3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis
A study testing Cationorm Pro and Vismed in people with Dry Eye Syndromes, run by Santen SAS at 8 sites in 3 countries.
Trial summary
This study is a prospective, multicentre, parallel-group, active-controlled, non-inferiority study conducted in adult patients with moderate-to-severe dry eye disease (DED) related to keratitis or keratoconjunctivitis. This study is to be conducted in France, Poland and Spain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Cationorm Pro and Vismed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 30 Sep 2021to 28 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient aged 18 years or above.
- Patient using artificial tears for at least 3 months prior to the Screening visit.
- Patient experiencing at least 2 symptoms of ocular discomfort rated ≥23 mm on the 0 to 100 mm visual analogue scale (VAS) (among itching, eye dryness, sticky feeling, photophobia, pain, burning or stinging, sandy feeling or grittiness, or foreign body sensation) at Screening and Baseline visits.
- OSS score (sum of nasal and temporal interpalpebral conjunctival and corneal vital staining) ≥4 and ≤9 on a modified Oxford scale at Screening and Baseline visits in at least one eye.
- TBUT of ≤10 seconds at Screening and Baseline visits and/or Schirmer's tear test of ≥3 and ≤9 mm/5 min at Screening visit in the same eye that fulfil inclusion criteria #4.
- The patient has signed and dated a written informed consent form prior to the initiation of any study procedures.
- -
Who cannot join
- the study: Ocular
- CFS score ≥4 on a modified Oxford scale
- Ocular hypertension or glaucoma requiring IOP-lowering medication(s)
- History of ocular trauma, infection or ocular inflammatory condition within the last 3 months before the screening visit.
- Severe blepharitis and/or severe meibomian gland disease
- Filamentary keratitis
Show all 24Show fewer
- Any ocular surface anomaly not related to DED
- Active ocular infection or history of ocular allergy or ocular herpes
- Patient with only one sighted eye or with a best corrected distance visual acuity ≤1/10
- Use of any topical ocular treatment other than study device during the study (all non-study topical ocular treatment(s) must be stopped at the screening visit)
- Onset of lid hygiene (whatever the method) less than 2 months before the Screening visit
- Use of topical corticosteroids one month before the Screening Visit
- Use of isotretinoin, ciclosporin, tacrolimus, sirolimus, pimecrolimus or ocular cauterisation procedures 2 months before the screening visit and throughout the study
- Use of VISMED® within 6 weeks prior to the screening visit
- Refractive surgery (e.g. LASIK, LASEK, PRK) within 6 months and/or any other ocular laser/surgery within 3 months prior to the screening visit and during the study
- Insertion of temporary punctal plug(s) within 2 months prior to the Screening visit or permanent occlusion of lacrimal puncta on one or both sides
- Known hypersensitivity to any of the components of the study device or investigational products Non-ocular
- History of severe systemic allergy
- Systemic disease not stabilised within 1 month prior to the screening visit (e.g. diabetes with glycaemia out of range, thyroid dysfunction) or judged by the investigator to be incompatible with the conduct of the study procedures or the interpretation of the study results
- Any change of systemic concomitant medication within the month before the screening visit or planned change during the study period, except paracetamol
- Pregnancy or lactation at the screening and/or Baseline visit.
- Women of childbearing potential not using a medically acceptable, highly effective method of birth control (such as hormonal implants, injectable or oral contraceptives together with condoms, some intrauterine devices, sexual abstinence or vasectomised partner) from the Baseline visit throughout the conduct of the study treatment periods and up to 2 weeks after the study end. Post-menopausal women (two years without menstruation) do not need to use any method of birth control.
- Participation in a clinical trial with an investigational substance within the past 30 days prior to Baseline visit.
- Participation in another clinical study at the same time as the present study. -
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Spain4 sites
Centro de Oftalmologia Barraquer
Barcelona
Hospital Clinic of Barcelona
Barcelona
Hospital Unniversitario Donostia
Donostia / San Sebastian
El Instituto Ofalmológico Quirónsalud Zaragoza
Zaragoza
Poland3 sites
Gabinet Okulistyczny
Bielsko-Biala
5th MILITARY CLINICAL HOSPITAL IN KRAKOW
Krakow
Szpital SW. Rozy
Krakow
About this study
Official title: A 3-month, Prospective, Multicentre, Investigator-masked, Parallel-group, Active-controlled, Randomised, Non-inferiority Study to Compare the Efficacy & Tolerability of CATIONORM PRO® & VISMED® in Patients With Mod-to-severe Dry Eye Disease
This study is a prospective, multicentre, parallel-group, active-controlled, non-inferiority study conducted in adult patients with moderate-to-severe dry eye disease (DED) related to keratitis or keratoconjunctivitis. This study is to be conducted in France, Poland and Spain.
The patients will be randomised to receive Cationorm Pro® or the reference treatment, VISMED® (ratio 1:1) in an investigator-masked fashion
Read the detailed description
Primary:
- To compare the ocular efficacy of Cationorm Pro® with that of VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis after a 4-week treatment period (Day 28).
Secondary:
To compare the ocular efficacy of Cationorm Pro® with that of VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis over a 12-week treatment period To evaluate the ocular tolerability and safety of Cationorm Pro® versus VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis throughout the duration of treatment
- Conditions
- Dry Eye Syndromes
- Being tested
- Cationorm Pro, Vismed
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cationorm ProDevice
Also called Ocutears Pro+
Eye Drops
VismedDevice
Eye Drops
| Study group | Role | What they receive |
|---|---|---|
| Cationorm Pro | Experimental | Cationorm Pro is an ophthalmic sterile unpreserved eye drops emulsion (N=40) Posology: One Drop in each eye 4 times daily for 84 days Receives: Device: Cationorm Pro |
| Vismed | Active comparator | HA 0.18% hyaluronic solution (N40) Posology: One Drop in each eye 4 times daily for 84 days Receives: Device: Vismed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of ocular surface staining (OSS) score between baseline and Day 28.
The primary endpoint of the study is the difference between patients treated with Cationorm Pro® and patients treated with VISMED® in the change of ocular surface staining (OSS) score between baseline and D28.
An OSS higher than 0 is considered to be abnormal and may be a sign of KCS. But scores of 1 or 2 can also represent a late staining artifact if interpretation of the fluorescein corneal staining pattern is delayed beyond 8 minutes. Because this could lead to a high level of misclassification, an abnormal OSS is defined as being a score of 3 or above.
Measured: Between Baseline and day 28
Secondary outcomes (7)
Change of ocular surface staining (OSS) score between baseline and Day 84
The difference between patients treated with Cationorm Pro® and patients treated with VISMED® in change of OSS score between baseline and Day 84.
An OSS higher than 0 is considered to be abnormal and may be a sign of KCS. But scores of 1 or 2 can also represent a late staining artifact if interpretation of the fluorescein corneal staining pattern is delayed beyond 8 minutes. Because this could lead to a high level of misclassification, an abnormal OSS is defined as being a score of 3 or above.
Measured: between baseline and Day 14 and between baseline and Day 84
The change of ocular stainings (corneal fluorescein staining (CFS) and conjunctival staining) between baseline and Day 28 and between baseline and Day 84
The difference between patients treated with Cationorm Pro® and patients treated with VISMED® in change of ocular stainings (corneal fluorescein staining (CFS) and conjunctival staining)
Staining using fluorescein will be graded using the modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5 per area [cornea + nasal and temporal conjunctiva]) for cornea and conjunctiva separately, On this modified scale, the score 0 corresponds to no staining dots and the score 0.5 corresponds to one staining dot per area. A CFS grade of 0 represents complete corneal clearing.
Measured: between baseline and Day 28 and between baseline and Day 84
The change of ocular discomfort symptoms on Visual Analogue Scale
The difference between patients treated with Cationorm Pro® and patients treated with VISMED® in the change of ocular discomfort symptoms according to the Visual Analogue Scale (VAS)
Patient experiencing at least 2 symptoms of ocular discomfort rated ≥23 mm on the 0 to 100 mm visual analogue scale (VAS) (among itching, eye dryness, sticky feeling, photophobia, pain, burning or stinging, sandy feeling or grittiness, or foreign body sensation) at Screening and Baseline visits.
Measured: between baseline and Day 28 and between baseline and Day 84
The change tear breakup time (TBUT)
The difference between patients treated with Cationorm Pro® and patients treated with VISMED® in the change of tear breakup time (TBUT)
Generally, >10 seconds is thought to be normal,(10, 11, 12) 5 to 10 seconds, marginal, and < 5 seconds is considered low. A short tear break-up time is a sign of a poor tear film and the longer it takes the more stable the tear film.
Measured: between baseline and Day 28 and between baseline and Day 84
The change in Schirmer's tear test
The difference between patients treated with Cationorm Pro® and patients treated with VISMED® in the change of Schirmer's tear test
Healthy eyes are considered to leave each strip of paper containing more than 10 millimeters of moisture. Less than 10 millimeters of moisture indicates probable dry eye syndrome
Measured: between baseline and Day 28 and between baseline and Day 84
The secondary endpoints are the difference between patients treated with Cationorm Pro® and patients treated with VISMED® in the change of overall efficacy evaluation of the investigator
The study investigator at each centre will conduct an overall assessment of the effect of the study device on improvement in the patients DED using the following rating scale:
0 = Unsatisfactory
- = Not very satisfactory
- = Satisfactory
- = Very satisfactory
Measured: after 12 weeks of treatment (84 days)
The difference between patients treated with Cationorm Pro® and patients treated with VISMED® in the change of subjective assessments evaluation by the patient.
The patient will rate his global evaluation of efficacy using the same rating scale as the Investigator.
A subjective assessment is completed of the effect of the study device on improvement in their DED using the following rating scale:
0 = Unsatisfactory
- = Not very satisfactory
- = Satisfactory
- = Very satisfactory
Measured: between baseline and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start30 Sep 2021
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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
- PROSPECTIVE, MULTICENTRE, INVESTIGATOR-MASKED, PARALLEL-GROUP, ACTIVE-CONTROLLED, RANDOMISED, NON-INFERIORITY STUDY
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701086
- Sponsor's protocol ID
- RE-010-2020-SA
- Acronym
- PROSIKA
- Status last verified
- May 2025
- First submitted
- 5 Jan 2021
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-month, Prospective, Multicentre, Investigator-masked, Parallel-group, Active-controlled, Randomised, Non-inferiority Study to Compare the Efficacy & Tolerability of CATIONORM PRO® & VISMED® in Patients With Mod-to-severe Dry Eye Disease
- ClinicalTrials.gov ID
- NCT04701086
- Acronym / sponsor ID
- PROSIKA / RE-010-2020-SA
- Conditions
- Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Santen SASIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 8 Jan 2021 (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.
This study is a prospective, multicentre, parallel-group, active-controlled, non-inferiority study conducted in adult patients with moderate-to-severe dry eye disease (DED) related to keratitis or keratoconjunctivitis. This study is to be conducted in France, Poland and Spain.
The patients will be randomised to receive Cationorm Pro® or the reference treatment, VISMED® (ratio 1:1) in an investigator-masked fashion
Detailed description
Primary:
- To compare the ocular efficacy of Cationorm Pro® with that of VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis after a 4-week treatment period (Day 28).
Secondary:
To compare the ocular efficacy of Cationorm Pro® with that of VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis over a 12-week treatment period To evaluate the ocular tolerability and safety of Cationorm Pro® versus VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis throughout the duration of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- PROSPECTIVE, MULTICENTRE, INVESTIGATOR-MASKED, PARALLEL-GROUP, ACTIVE-CONTROLLED, RANDOMISED, NON-INFERIORITY STUDY
| Arm | Type | Receives |
|---|---|---|
| Cationorm Pro | Experimental | Device: Cationorm ProCationorm Pro is an ophthalmic sterile unpreserved eye drops emulsion (N=40) Posology: One Drop in each eye 4 times daily for 84 days |
| Vismed | Active comparator | Device: VismedHA 0.18% hyaluronic solution (N40) Posology: One Drop in each eye 4 times daily for 84 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patient aged 18 years or above.
- Patient using artificial tears for at least 3 months prior to the Screening visit.
- Patient experiencing at least 2 symptoms of ocular discomfort rated ≥23 mm on the 0 to 100 mm visual analogue scale (VAS) (among itching, eye dryness, sticky feeling, photophobia, pain, burning or stinging, sandy feeling or grittiness, or foreign body sensation) at Screening and Baseline visits.
- OSS score (sum of nasal and temporal interpalpebral conjunctival and corneal vital staining) ≥4 and ≤9 on a modified Oxford scale at Screening and Baseline visits in at least one eye.
- TBUT of ≤10 seconds at Screening and Baseline visits and/or Schirmer's tear test of ≥3 and ≤9 mm/5 min at Screening visit in the same eye that fulfil inclusion criteria #4.
Key exclusion criteria (24 listed)
- the study: Ocular
- CFS score ≥4 on a modified Oxford scale
- Ocular hypertension or glaucoma requiring IOP-lowering medication(s)
- History of ocular trauma, infection or ocular inflammatory condition within the last 3 months before the screening visit.
- Severe blepharitis and/or severe meibomian gland disease
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 |
|---|---|---|
| Cationorm ProAlso: Ocutears Pro+Eye Drops | Device | Cationorm Pro |
| VismedEye Drops | Device | Vismed |
Primary outcome
Change of ocular surface staining (OSS) score between baseline and Day 28.
Time frame: Between Baseline and day 28
The primary endpoint of the study is the difference between patients treated with Cationorm Pro® and patients treated with VISMED® in the change of ocular surface staining (OSS) score between baseline and D28. An OSS higher than 0 is considered to be abnormal and may be a sign of KCS. But scores of 1 or 2 can also represent a late staining artifact if interpretation of the fluorescein corneal staining pattern is delayed beyond 8 minutes. Because this could lead to a high level of misclassification, an abnormal OSS is defined as being a score of 3 or above.
7 secondary outcomes
Change of ocular surface staining (OSS) score between baseline and Day 84
Time frame: between baseline and Day 14 and between baseline and Day 84
The change of ocular stainings (corneal fluorescein staining (CFS) and conjunctival staining) between baseline and Day 28 and between baseline and Day 84
Time frame: between baseline and Day 28 and between baseline and Day 84
The change of ocular discomfort symptoms on Visual Analogue Scale
Time frame: between baseline and Day 28 and between baseline and Day 84
The change tear breakup time (TBUT)
Time frame: between baseline and Day 28 and between baseline and Day 84
The change in Schirmer's tear test
Time frame: between baseline and Day 28 and between baseline and Day 84
The secondary endpoints are the difference between patients treated with Cationorm Pro® and patients treated with VISMED® in the change of overall efficacy evaluation of the investigator
Time frame: after 12 weeks of treatment (84 days)
The difference between patients treated with Cationorm Pro® and patients treated with VISMED® in the change of subjective assessments evaluation by the patient.
Time frame: between baseline and Day 84
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 21 May 2025.
- Individual participant dataSharing planned: No
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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.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cationorm Pro and Vismed in people with Dry Eye Syndromes, run by Santen SAS at 8 sites in 3 countries.
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 24 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 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Poland, France. 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?
Change of ocular surface staining (OSS) score between baseline and Day 28. (time frame: Between Baseline and day 28). 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 21 May 2025.