Dry Eye SyndromeNCT03803722
To Demonstrate the Non-inferiority of Eyestil Protection® Compared to Vismed® in Terms of Clinical Performance
A study testing Eyestil Protection® unidose in people with Dry Eye Syndrome, run by SIFI SpA at 11 sites in 2 countries.
Trial summary
This is a national, prospective, multicenter, comparative, randomized, single-blinded non-inferiority study performed in two parallel groups. 3 months (plus a run in period of 15 days prior inclusion) Patients with moderate to severe dry eye syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Eyestil Protection® unidose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 8 Jul 2019to 30 Jun 2020
- 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
- Adult patients, male or female, of at least 18 years of age at the screening visit
- Patients understanding the study, willing to follow the instructions and providing their written Informed Consent Form to participate
- Patients with moderate up severe dry eye with keratoconjunctivitis sicca diagnosed at least 4 weeks before the screening visit
- Patients using artificial tears at least once a day for at least 4 weeks before the screening visit
- Patients with corneal/conjunctival lesions consistent with a diagnosis of keratoconjunctivitis measured by tests of staining: i.e. the overall score of the corneal staining test must be ≥ 3 and ≤ 9 on the 15-point Oxford scale
- And at least one of the following element: Tear volume decreased: must be either present a Schirmer test ≥ 3 mm and ≤ 9 mm / 5 minutes or the sum of 3 consecutive measurements of the tear film break-up time (TBUT) ≤ 30s for at least one eye;
- OSDI score ≥18
- Covered by healthcare insurance.
Who cannot join
- Patients with medical history of herpetic keratitis, peripheral ulcerative keratitis, sclerites, diabetic retinopathy
- Any systemic disease that is not well controlled for at least 2 months (e.g. lupus, rheumatoid arthritis, thyroiditis…) according to clinical judgment
- Patients using any topical therapies such as non-steroidal anti-inflammatory drugs, cortisone, cyclosporine, vasoconstrictor
- Patients with at least one of the following concomitant ocular inflammatory disease: Stevens Johnson Disease, Atopic Keratoconjunctivitis; Scarlet Eye Pemphigoid
- Patients with anomalies of the eyelid, sucking, infectious conjunctivitis, pterygia, and/or a glaucoma treated with eyedrops
- Presence of graft versus host disease (GVHD)
Show all 14Show fewer
- Patients who have undergone surgery in the eye, within three months before the study enrolment
- Patients who have undergone corneal transplantation or refractive surgery or plan to undergo any eye surgery in the next four months
- Patients with known or suspected eye allergy
- Patients with a condition or history that, in the opinion of the investigator, may interfere significantly with the subject's participation in the study
- Female pregnant, planning a pregnancy during the study period and nursing an infant
- Patients who are participating or have participated in other clinical trial with investigational drug or device within 30 days prior to screening
- Patients unable to be compliant with the study procedures and requirements, according to the opinion of the investigator
- Patient deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection (e.g. guardianship or curatorship)
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
France10 sites
CHU d'Amiens
Amiens
Centre Rétine Anjou
Angers, 49000
Cabinet d'ophtalmologie Fosh
Bordeaux
Hopital Saint Vincent de Paul
Lille
Hopital Edouard Herriot
Lyon
Hôpital Saint Joseph
Marseille
Chu Kremlin-Bicetre
Paris, 94270
APHP - Hôpital Cochin
Paris
Centre Hospitalier Universitaire de Rennes
Rennes
CHU Strasbourg
Strasbourg
About this study
Official title: A Prospective Multicenter, Comparative, Randomized, Single-blind, Non-inferiority Study of Eyestil Protection® Unidose Versus Vismed® Unidose in Patients With Moderate to Severe Dry Eye Syndrome
This is a national, prospective, multicenter, comparative, randomized, single-blinded non-inferiority study performed in two parallel groups.
3 months (plus a run in period of 15 days prior inclusion) Patients with moderate to severe dry eye syndrome.
Read the detailed description
Public hospitals and private practices specialized in ophthalmology Approximately 10 sites France Approximately 80 patients globally: 40 per arm with a 1:1 ratio including an expected dropout rate of 15%.
Dry eye has been defined as a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film and accompanied by ocular symptoms, in which the tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.
However, prevalence estimates for dry eye vary dramatically from 5% to 50% due to the various operational definitions of dry eye used and the characteristics of the population studied.
The available evidence suggests also that dry eye has a negative impact on overall quality of life. It causes pain and irritation and affects ocular and general health and well-being, the perception of visual function and visual performance. Reduced quality of life in everyday activities and leisure pursuits is reported by 60% of patients, while 38% of patients complain of reduced efficiency at work.
Therefore, the economic burden and impact of dry eye on vision and quality of life, work productivity, psychological and physical impact of pain are considerable. As a consequence, dry eye represents a public health burden. However, only a handful of therapies are available for dry eye patient and are used according to the disease severity.
In such context, SIFI SpA. has developed Eyestil Protection® (or SF-104 XNT Single dose). It is a sterile preservative-free device (eye drops) for ophthalmic use containing 0.2% xanthan gum, presented in 0.3 ml unidose containers. The main action of Eyestil Protection is to lubricate and moisturize the ocular surface as well as to protect it from oxidative stress thanks to the anti-oxidative properties of the xanthan gum (as demonstrated by in-vitro studies (Amico, Tornetta et al. 2015). It is indicated in all cases of dry-eye related ocular discomfort and to relief ocular discomfort due to the use of contact lenses.
Eyestil Protection® unidose is CE marked but is not available yet in all European countries, notably in France.
Confronted to a European regulatory change on medical devices - from a Directive (Directive 1993/42/EEC) to a Regulation (MDR 2017/745) that now requires clinical evidence of device performance and safety; SIFI SpA decided to implement the present clinical comparative performance study. The choice of Vismed® (unidose) as the comparator has been done since it is the current French standard of care treatment for patients with moderate to severe dry eyes.
Primary objective
- To demonstrate the non-inferiority of Eyestil Protection® compared to Vismed® in terms of clinical performance as detected by a reduction of keratitis lesions objectified by staining tests after 1 month of treatment, in patients with moderate to severe dry eye syndrome with keratoconjunctivitis.
Secondary objectives Clinical performance
- To evaluate the tear film stability per group as objectified by the tear break up time (TBUT) test at month 1 and 3;
- To evaluate the long term clinical performance of Eyestil Protection® compared to Vismed® as detected by a reduction of keratitis lesions objectified by staining tests after 3 months of treatment;
- To evaluate the tear production per group as objectified by the Schirmer test at month 3.
Patient reported outcomes
- To compare patients reported outcomes (PRO) measures per group at month 1 and 3, including:
- Patient's reported symptoms and
- Patient's quality of life (QoL). Investigator overall satisfaction
- To assess investigator's overall satisfaction of the treatment's clinical performance at month 1 and 3.
Safety • To describe the safety profile of Eyestil Protection® compared to Vismed® after 3 months of treatment.
Exploratory objectives
- To compare patient's QoL subscale scores per group at each time point.
- Conditions
- Dry Eye Syndrome
- Being tested
- Eyestil Protection® unidose
- 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.
Eyestil Protection® unidoseDevice
to demonstrate the non-inferiority of Eyestil Protection® in terms of performance and safety, when compared to Vismed® in treatment of dry eye disease.
| Study group | Role | What they receive |
|---|---|---|
| Arm A Eyestil Protection® | Experimental | No inferiority of Eyestil Protection® unidose versus Vismed® unidose The intervention consists of Eyestil Protection® : sterile preservative free, medical device, class IIa and CE marked. It contains 0.2% xanthan gum, presented in 0.3 ml unidose containers. It is not available yet on the French Market.
dosage: 6 drops a day for three months period. Receives: Device: Eyestil Protection® unidose |
| Arm B Vismed® | No intervention | Vismed®: sterile preservative free, medical device class IIb and CE marked. It contains 0.18% sodium hyaluronate, presented in 0.3 ml unidose containers. It is already on the French market. dosage: 6 drops a day for three months period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint/clinical performance by Oxford scale
Clinical performance of the medical device under investigation: the between-group comparison of the average variation of the global fluorescein corneal and lissamine green conjunctival staining using the Oxford scale (0 to 15). This refers to the average variation between both time points of the Global Ocular Staining Score of the study eye (GOSS).
0-5 cornea; 0-5 temporal conjuctiva; 0-5 nasal conjunctiva. Max total score: 15
Measured: between Day 1 and Day 35 ±4.
Secondary outcomes (6)
Secondary endpoint/clinical performance by TBUT test
The between-group comparisons of the average variation of the time obtained at the tear break up time test (TBUT). This full procedure will be performed 3 times per eye and per time point. Each obtained time will be recorded by the investigator in the eCRF. At screening and at baseline visits, the sum of these 3 times for at least one eye to be eligible must be ≤ 30 seconds.
Conventionally TBUT's measures shorter than 10 seconds can be referred to tear film instability and measures shorter than 5 seconds, usually, are undoubtable sign of dry eye. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement) and a negative number change from baseline indicates a decrease in TBUT (worsening).
Measured: between Day 1 and Day 35 ±4 and Day 1 and Day 84 ±7
Secondary endpoint/patient reported outcome by DEQS questionnaire
The between-group comparisons of the average variation of Dry Eye-Related Quality-of-Life (DEQS) general score. It is a validated 15-item scale divided into 2 subscales related to dry eye symptoms and its influence on daily life:
The frequency is scored on a 5-point Likert scale ranging from 0 (no symptom) to 4 (highest frequency).
- The degree is scored on a 4-point Likert scale ranging from 1 to 4, a larger number indicates a greater burden.
The summary score ranges from 0 to 100, higher score indicates higher disability. .
Measured: between Day 1 and Day 35 ±4 and Day 1 and Day 84 ±7
Secondary endpoint/safety
The description of all adverse events, related and unrelated to the medical devices, anticipated or unanticipated
Measured: between Day 1 and Day 84 ±7
Secondary endpoint/clinical performance by Oxford scale
The between-group comparison of the average variation of the global fluorescein corneal and lissamine green conjunctival staining using the Oxford scale (0-15).This refers to the average variation between both time points of the of the Global Ocular Staining Score of the study eye (GOSS) and the comparison between both treatment groups. -5 cornea; 0-5 temporal conjuctiva; 0-5 nasal conjunctiva. Max total score: 15
Measured: between Day 1 and Day 84 ±7
Secondary endpoint/clinical performance by Schirmer test
The between-group comparisons of the average variation of the paper length obtained at the Schirmer Test. The Schirmer test without anesthesia will be here performed to measure the rate of secretion of tears produced by the study eye over 5 minutes.The cut-off value for a severe dry eye in the first one is 6 mm. But the cut-off that will here use will be 9 mm with the following interpretation:
- Normal = ≥ 10 millimeters (mm) of tears,
- Dry Eye = ≤ 9 mm of tears A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).
Measured: between [Day 1 and Day 84 ±7]
Secondary endpoint/patient reported outcome by OSDI score
The between-group comparisons of the average variation of Ocular Symptoms Disease Index (OSDI) score. The patient's dry eye symptoms will be assessed with the Ocular Surface Disease Index (OSDI). It is a validated 12-questions scale for patients that covers a broad spectrum of ocular surface symptoms, the severity of such symptoms for patients and how these symptoms affect/impact visual function over a 1-week recall period. Its scores range from 0 to 100, with higher scores indicating greater severity of disease.Positive result is considered when the OSDI score is ≥ 18.To be consistent with the IMD indication, patient with moderate to severe dry eye thus with an OSDI ≥ 18 will be selected. If the patient's OSDI score will be strictly below 18 at the screening or baseline visit, s/he will be considered as a screening failure.
Each item response will be collected in the study database since given separately to patients.
Measured: between [Day 1 and Day 35 ±4] and [Day 1 and Day 84 ±7]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start8 Jul 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: Slow enrolment process and COVID situation worsened the situation. SIFI has developed a new product with probably a better performance. SIFI changed its marketing strategy and decided that Eyestil® Protection will be not marketed anymore
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Approximately 80 patients globally: 40 per arm with a 1:1 ratio including an expected dropout rate of 15%. Single masked. Medical Device
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- SIFI SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Labetoulle, MD; Pr, Principal investigator, CHU KREMLIN-BICETRE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803722
- Sponsor's protocol ID
- 048/SI
- Status last verified
- May 2022
- First submitted
- 10 Dec 2018
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter, Comparative, Randomized, Single-blind, Non-inferiority Study of Eyestil Protection® Unidose Versus Vismed® Unidose in Patients With Moderate to Severe Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT03803722
- Acronym / sponsor ID
- 048/SI
- Conditions
- Dry Eye Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrolment process and COVID situation worsened the situation. SIFI has developed a new product with probably a better performance. SIFI changed its marketing strategy and decided that Eyestil® Protection will be not marketed anymore
- Enrolment
- 21 participants (actual)
- Lead sponsor
- SIFI SpAIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 15 Jan 2019 (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 is a national, prospective, multicenter, comparative, randomized, single-blinded non-inferiority study performed in two parallel groups.
3 months (plus a run in period of 15 days prior inclusion) Patients with moderate to severe dry eye syndrome.
Detailed description
Public hospitals and private practices specialized in ophthalmology Approximately 10 sites France Approximately 80 patients globally: 40 per arm with a 1:1 ratio including an expected dropout rate of 15%.
Dry eye has been defined as a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film and accompanied by ocular symptoms, in which the tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.
However, prevalence estimates for dry eye vary dramatically from 5% to 50% due to the various operational definitions of dry eye used and the characteristics of the population studied.
The available evidence suggests also that dry eye has a negative impact on overall quality of life. It causes pain and irritation and affects ocular and general health and well-being, the perception of visual function and visual performance. Reduced quality of life in everyday activities and leisure pursuits is reported by 60% of patients, while 38% of patients complain of reduced efficiency at work.
Therefore, the economic burden and impact of dry eye on vision and quality of life, work productivity, psychological and physical impact of pain are considerable. As a consequence, dry eye represents a public health burden. However, only a handful of therapies are available for dry eye patient and are used according to the disease severity.
In such context, SIFI SpA. has developed Eyestil Protection® (or SF-104 XNT Single dose). It is a sterile preservative-free device (eye drops) for ophthalmic use containing 0.2% xanthan gum, presented in 0.3 ml unidose containers. The main action of Eyestil Protection is to lubricate and moisturize the ocular surface as well as to protect it from oxidative stress thanks to the anti-oxidative properties of the xanthan gum (as demonstrated by in-vitro studies (Amico, Tornetta et al. 2015). It is indicated in all cases of dry-eye related ocular discomfort and to relief ocular discomfort due to the use of contact lenses.
Eyestil Protection® unidose is CE marked but is not available yet in all European countries, notably in France.
Confronted to a European regulatory change on medical devices - from a Directive (Directive 1993/42/EEC) to a Regulation (MDR 2017/745) that now requires clinical evidence of device performance and safety; SIFI SpA decided to implement the present clinical comparative performance study. The choice of Vismed® (unidose) as the comparator has been done since it is the current French standard of care treatment for patients with moderate to severe dry eyes.
Primary objective
- To demonstrate the non-inferiority of Eyestil Protection® compared to Vismed® in terms of clinical performance as detected by a reduction of keratitis lesions objectified by staining tests after 1 month of treatment, in patients with moderate to severe dry eye syndrome with keratoconjunctivitis.
Secondary objectives Clinical performance
- To evaluate the tear film stability per group as objectified by the tear break up time (TBUT) test at month 1 and 3;
- To evaluate the long term clinical performance of Eyestil Protection® compared to Vismed® as detected by a reduction of keratitis lesions objectified by staining tests after 3 months of treatment;
- To evaluate the tear production per group as objectified by the Schirmer test at month 3.
Patient reported outcomes
- To compare patients reported outcomes (PRO) measures per group at month 1 and 3, including:
- Patient's reported symptoms and
- Patient's quality of life (QoL). Investigator overall satisfaction
- To assess investigator's overall satisfaction of the treatment's clinical performance at month 1 and 3.
Safety • To describe the safety profile of Eyestil Protection® compared to Vismed® after 3 months of treatment.
Exploratory objectives
- To compare patient's QoL subscale scores per group at each time point.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Approximately 80 patients globally: 40 per arm with a 1:1 ratio including an expected dropout rate of 15%. Single masked. Medical Device
| Arm | Type | Receives |
|---|---|---|
| Arm A Eyestil Protection® | Experimental | Device: Eyestil Protection® unidoseNo inferiority of Eyestil Protection® unidose versus Vismed® unidose The intervention consists of Eyestil Protection® : sterile preservative free, medical device, class IIa and CE marked. It contains 0.2% xanthan gum, presented in 0.3 ml unidose containers. It is not available yet on the French Market. dosage: 6 drops a day for three months period. |
| Arm B Vismed® | No intervention | –Vismed®: sterile preservative free, medical device class IIb and CE marked. It contains 0.18% sodium hyaluronate, presented in 0.3 ml unidose containers. It is already on the French market. dosage: 6 drops a day for three months period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients, male or female, of at least 18 years of age at the screening visit
- Patients understanding the study, willing to follow the instructions and providing their written Informed Consent Form to participate
- Patients with moderate up severe dry eye with keratoconjunctivitis sicca diagnosed at least 4 weeks before the screening visit
- Patients using artificial tears at least once a day for at least 4 weeks before the screening visit
- Patients with corneal/conjunctival lesions consistent with a diagnosis of keratoconjunctivitis measured by tests of staining: i.e. the overall score of the corneal staining test must be ≥ 3 and ≤ 9 on the 15-point Oxford scale
Key exclusion criteria (14 listed)
- Patients with medical history of herpetic keratitis, peripheral ulcerative keratitis, sclerites, diabetic retinopathy
- Any systemic disease that is not well controlled for at least 2 months (e.g. lupus, rheumatoid arthritis, thyroiditis…) according to clinical judgment
- Patients using any topical therapies such as non-steroidal anti-inflammatory drugs, cortisone, cyclosporine, vasoconstrictor
- Patients with at least one of the following concomitant ocular inflammatory disease: Stevens Johnson Disease, Atopic Keratoconjunctivitis; Scarlet Eye Pemphigoid
- Patients with anomalies of the eyelid, sucking, infectious conjunctivitis, pterygia, and/or a glaucoma treated with eyedrops
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 |
|---|---|---|
| Eyestil Protection® unidoseto demonstrate the non-inferiority of Eyestil Protection® in terms of performance and safety, when compared to Vismed® in treatment of dry eye disease. | Device | Arm A Eyestil Protection® |
Primary outcome
Primary endpoint/clinical performance by Oxford scale
Time frame: between Day 1 and Day 35 ±4.
Clinical performance of the medical device under investigation: the between-group comparison of the average variation of the global fluorescein corneal and lissamine green conjunctival staining using the Oxford scale (0 to 15). This refers to the average variation between both time points of the Global Ocular Staining Score of the study eye (GOSS). 0-5 cornea; 0-5 temporal conjuctiva; 0-5 nasal conjunctiva. Max total score: 15
6 secondary outcomes
Secondary endpoint/clinical performance by TBUT test
Time frame: between Day 1 and Day 35 ±4 and Day 1 and Day 84 ±7
Secondary endpoint/patient reported outcome by DEQS questionnaire
Time frame: between Day 1 and Day 35 ±4 and Day 1 and Day 84 ±7
Secondary endpoint/safety
Time frame: between Day 1 and Day 84 ±7
Secondary endpoint/clinical performance by Oxford scale
Time frame: between Day 1 and Day 84 ±7
Secondary endpoint/clinical performance by Schirmer test
Time frame: between [Day 1 and Day 84 ±7]
Secondary endpoint/patient reported outcome by OSDI score
Time frame: between [Day 1 and Day 35 ±4] and [Day 1 and Day 84 ±7]
Results and safety
The study was stopped early (reason given: Slow enrolment process and COVID situation worsened the situation. SIFI has developed a new product with probably a better performance. SIFI changed its marketing strategy and decided that Eyestil® Protection will be not marketed anymore). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
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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.
Marc Labetoulle, MD; Pr principal investigator
CHU KREMLIN-BICETRE
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eyestil Protection® unidose in people with Dry Eye Syndrome, run by SIFI SpA at 11 sites in 2 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 8 inclusion and 14 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: stopped early, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Spain. 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 was stopped early (reason given: Slow enrolment process and COVID situation worsened the situation. SIFI has developed a new product with probably a better performance. SIFI changed its marketing strategy and decided that Eyestil® Protection will be not marketed anymore). Results are not available in the source record.
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?
Primary endpoint/clinical performance by Oxford scale (time frame: between Day 1 and Day 35 ±4.). 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 9 May 2022.