Dry EyeNCT03645850
Evaluation of Efficacy and Safety of Vismed Gel Multi 0.3% Versus Vismed Multi 0.18% on Treatment of Ocular Dryness
A study testing Vismed gel Multi 0.3% eye drops and Vismed Multi 0.18% eye drops in people with Dry Eye, run by Horus Pharma.
Trial summary
This study is a multicentric, comparative, randomized, investigator-blinded, parallel group study to demonstrate the non-inferiority of Vismed® Gel Multi 0.3% in comparison with Vismed® Multi 0.18% in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Vismed gel Multi 0.3% eye drops and Vismed Multi 0.18% eye drops
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 15 Jun 2019
- 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
- Sex: male or female.
- Age: more than 18 years.
- Subject with a moderate to severe dry eye syndrome needing artificial tears in the 3 months preceding the inclusion.
- Subject having used only artificial tears without preservative (NaCl 0.9%, Hydrabak®) during 1 to 2 weeks before inclusion (up to 6 times a day).
- Subject with a score ≥ 6 for the 5-Item Dry Eye Questionnaire (DEQ-5)
- Subject with at least one eye with:
Show all 13Show fewer
- Global ocular staining (cornea and conjunctiva) ≥4 and ≤9 on the Oxford scale (0 to 15)
- AND one of the following criteria:
- Schirmer test ≥ 3 mm/5 min and ≤ 9 mm/5 min OR
- Sum of 3 measurements of Tear film Break-Up Time (TBUT) ≤ 30s.
- Subject, having given freely and expressly his/her informed consent.
- Subject who is able to comply with the study requirements, as defined in the present CIP, at the Investigator's appreciation.
- In France: subject being affiliated to a health social security system. Female subjects of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end.
Who cannot join
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject deprived of freedom by administrative or legal decision.
- Subject in a social or health institution
- Subject who is under guardianship or who is not able to express his/her consent.
- Subject being in an exclusion period for a previous study.
- Subject suspected to be non-compliant according to the Investigator's judgment.
Show all 23Show fewer
- Subject wearing contact lenses during the study.
- Far best corrected visual acuity < 1/10
- Subject with severe ocular dryness with one of these conditions:
- Eyelid or blinking malfunction
- Corneal disorders not related to dry eye syndrome
- Ocular metaplasia
- Filamentous keratitis
- Corneal neovascularization
- Subject with severe meibomian gland dysfunction (MGD)
- History of ocular trauma, infection or inflammation, not related to dry eye syndrome within the last 3 months prior to the inclusion.
- History of ocular allergy or ocular herpes within the last 12 months.
- Subjects who underwent ocular surgery, including laser surgery, in either eye within the last 6 months.
- Any troubles of the ocular surface not related to dry eye syndrome.
- Subject having used artificial tears in the 6 hours preceding the inclusion visit.
- Use of the following ocular treatments: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus, punctual plugs during the month preceding the inclusion.
- Subjects who have received ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start or expected to receive ocular therapy during the study.
- Any not stabilised systemic treatment, which can have an effect on performance or safety criteria, at the investigator appreciation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Efficacy and Safety of Vismed® Gel Multi 0.3% Versus Vismed® Multi 0.18% on the Treatment of Moderate to Severe Ocular Dryness
This study is a multicentric, comparative, randomized, investigator-blinded, parallel group study to demonstrate the non-inferiority of Vismed® Gel Multi 0.3% in comparison with Vismed® Multi 0.18% in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.
Read the detailed description
Evaluation of the non-inferiority of Vismed® Gel Multi 0.3% in comparison with Vismed® Multi 0.18%, in terms of cornea and conjunctiva staining (Oxford score), on worse eye, between Day 0 and Day 35.
Evaluation of the non-inferiority of Vismed® Gel Multi 0.3% in comparison with Vismed® Multi 0.18%, in terms of cornea and conjunctiva staining (Oxford score), on worse eye, between Day 0 and Day 35.
- Comparison of Day 35 versus Day 0 and Day 84 versus Day 0 for each product and comparison between products for the following parameters:
- Evolution of cornea and conjunctiva staining (Oxford score) on worse eye.
- Evolution of DEQ-5 score (5-items Dry Eye Questionnaire).
- Evolution of Van Bijsterveld score (Lissamine green staining) in worse eye.
- Evolution of Schirmer test result in worse eye.
- Evolution of Tear film Break-Up Time (TBUT) in worse eye.
- Evolution of ocular dryness severity by evaluation of each main symptom by the patient and total score of all symptoms
- Evaluation of treatment performance by the investigator and the patient.
- Evaluation of the average frequency of use over 84 days for both products.
- Conditions
- Dry Eye
- Being tested
- Vismed gel Multi 0.3% eye drops, Vismed Multi 0.18% eye drops
- 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.
Vismed gel Multi 0.3% eye dropsDevice
Ophthalmic use. Vismed gel Multi 0.3% eye drops. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.
Vismed Multi 0.18% eye dropsDevice
Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Investig. device:Vismed Gel Multi 0.3% | Experimental | Vismed gel Multi 0.3% eye drops: 1 to 2 drops in each eye between 4 and 6 times per day during 84 days Receives: Device: Vismed gel Multi 0.3% eye drops |
| Comparative device: Vismed Multi 0.18% | Active comparator | Vismed Multi 0.18% eye drops: 1 to 2 drops in each eye between 4 and 6 times per day during 84 days Receives: Device: Vismed Multi 0.18% eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the non-inferiority of Vismed® Gel Multi 0.3% in comparison with Vismed® Multi 0.18% in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.
Assess the ocular surface fluorescein staining score- mean change from Baseline in the study at D35 in ocular surface fluorescein stainig score according to a scale from zero to 15
Measured: 35 days
To assess the total ocular surface fluorescein staining score at D84
Mean change from Baseline (D0) in the study eye and D84 in the total ocular surface fluoresceine staining score
Measured: 0 and 84 days
Evolution of DEQ-5 score
Evolution from Baseline of DEQ-5 questionnaire scores at day 35
Measured: 35 days
Evolution of DEQ-5 score
Evolution from Baseline of DEQ-5 questionnaire scores at day 84
Measured: 84 days
Evolution of Van Bijterveld score ( lissamine green staining)
Mean change from Baseline ( D0) and D 35 in the total Van Bijterveld score
Measured: 35 Days
Evolution of Van Bijterveld score ( lissamine green staining)
Mean change from Baseline ( D0) and D 84 in the total Van Bijterveld score
Measured: 84 days
Volume tear fluid secretion as assessed by schirmer test
Mean change from Baseline ( D0) in Volume tear fluid secretion as assessed
Measured: 35 days
Volume tear fluid secretion as assessed by schirmer test
Mean change from Baseline ( D0) in Volume tear fluid secretion as assessed
Measured: 84 days
Evolution of Tear film Break-Up Time
Mean change from Baseline (D0) in the study eye in TFBUT at Day 35
Measured: 35 days
Evolution of Tear film Break-Up Time
Mean change from Baseline (D0) in the study eye in TFBUT at Day 84
Measured: 84 days
Global sum score of dry eye symptoms at visit 3 - mean change from Baseline at visit 3 ( D35)
Mean change from Baseline in the global sum score of dry eye symptoms at D35 : discomfort,burning, stinging,eye dryness sensation, itching,foreign body sensation,photophobia, blurred vision.Each graded from 0 to 10
Measured: 35 days
Global sum score of dry eye symptoms at visit 4 - mean change from Baseline at visit 3 ( D84)
Mean change from Baseline in the global sum score of dry eye symptoms at D84 : discomfort,burning, stinging,eye dryness sensation, itching,foreign body sensation,photophobia, blurred vision.Each graded from 0 to 10
Measured: 84 days
Global treatment performance score assessed by the investigator at visit 3
Total Treatment performance score graded from 0 to 4
Measured: 35 days
Global treatment performance score assessed by the investigator at visit 4
Total Treatment performance score graded from 0 to 4
Measured: 84 days
Global treatment performance score assessed by the patient at visit 3
Total Treatment performance score graded from 0 to 4
Measured: 35 days
Global treatment performance score assessed by the patient at visit 4
Total Treatment performance score graded from 0 to 4
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion15 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Parallel Assignment Because the comparator will be in commercial packaging, the blinding of the subject is not possible. However, the study will be blinded for the investigator: evaluations will be done by an independent investigator, different than the person who will distribute the product. Subjects will be identified by a patient number. Each patient number will be associated to a treatment number, according to a randomization list provided before the beginning of the clinical investigation, and randomized either in one of both treatment groups (Vismed Gel Multi 3% or Vismed Multi 0.18%).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horus Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Béatrice Cochener-Lamard, Prof, Principal investigator, Hôpital Morvan, Brest, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645850
- Sponsor's protocol ID
- 17E4554
- Other IDs
- 2018-A01711-54
- Status last verified
- Aug 2018
- First submitted
- 22 Aug 2018
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on any journal publication of the results
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Vismed® Gel Multi 0.3% Versus Vismed® Multi 0.18% on the Treatment of Moderate to Severe Ocular Dryness
- ClinicalTrials.gov ID
- NCT03645850
- Acronym / sponsor ID
- 17E4554
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Horus PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 15 Jun 2019 (estimated)
- First posted
- 24 Aug 2018 (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 multicentric, comparative, randomized, investigator-blinded, parallel group study to demonstrate the non-inferiority of Vismed® Gel Multi 0.3% in comparison with Vismed® Multi 0.18% in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.
Detailed description
Evaluation of the non-inferiority of Vismed® Gel Multi 0.3% in comparison with Vismed® Multi 0.18%, in terms of cornea and conjunctiva staining (Oxford score), on worse eye, between Day 0 and Day 35.
Evaluation of the non-inferiority of Vismed® Gel Multi 0.3% in comparison with Vismed® Multi 0.18%, in terms of cornea and conjunctiva staining (Oxford score), on worse eye, between Day 0 and Day 35.
- Comparison of Day 35 versus Day 0 and Day 84 versus Day 0 for each product and comparison between products for the following parameters:
- Evolution of cornea and conjunctiva staining (Oxford score) on worse eye.
- Evolution of DEQ-5 score (5-items Dry Eye Questionnaire).
- Evolution of Van Bijsterveld score (Lissamine green staining) in worse eye.
- Evolution of Schirmer test result in worse eye.
- Evolution of Tear film Break-Up Time (TBUT) in worse eye.
- Evolution of ocular dryness severity by evaluation of each main symptom by the patient and total score of all symptoms
- Evaluation of treatment performance by the investigator and the patient.
- Evaluation of the average frequency of use over 84 days for both products.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment Because the comparator will be in commercial packaging, the blinding of the subject is not possible. However, the study will be blinded for the investigator: evaluations will be done by an independent investigator, different than the person who will distribute the product. Subjects will be identified by a patient number. Each patient number will be associated to a treatment number, according to a randomization list provided before the beginning of the clinical investigation, and randomized either in one of both treatment groups (Vismed Gel Multi 3% or Vismed Multi 0.18%).
| Arm | Type | Receives |
|---|---|---|
| Investig. device:Vismed Gel Multi 0.3% | Experimental | Device: Vismed gel Multi 0.3% eye dropsVismed gel Multi 0.3% eye drops: 1 to 2 drops in each eye between 4 and 6 times per day during 84 days |
| Comparative device: Vismed Multi 0.18% | Active comparator | Device: Vismed Multi 0.18% eye dropsVismed Multi 0.18% eye drops: 1 to 2 drops in each eye between 4 and 6 times per day during 84 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Sex: male or female.
- Age: more than 18 years.
- Subject with a moderate to severe dry eye syndrome needing artificial tears in the 3 months preceding the inclusion.
- Subject having used only artificial tears without preservative (NaCl 0.9%, Hydrabak®) during 1 to 2 weeks before inclusion (up to 6 times a day).
- Subject with a score ≥ 6 for the 5-Item Dry Eye Questionnaire (DEQ-5)
Key exclusion criteria (23 listed)
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject deprived of freedom by administrative or legal decision.
- Subject in a social or health institution
- Subject who is under guardianship or who is not able to express his/her consent.
- Subject being in an exclusion period for a previous study.
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 |
|---|---|---|
| Vismed gel Multi 0.3% eye dropsOphthalmic use. Vismed gel Multi 0.3% eye drops. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment. | Device | Investig. device:Vismed Gel Multi 0.3% |
| Vismed Multi 0.18% eye dropsOphthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment. | Device | Comparative device: Vismed Multi 0.18% |
Primary outcome
Demonstrate the non-inferiority of Vismed® Gel Multi 0.3% in comparison with Vismed® Multi 0.18% in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.
Time frame: 35 days
Assess the ocular surface fluorescein staining score- mean change from Baseline in the study at D35 in ocular surface fluorescein stainig score according to a scale from zero to 15
To assess the total ocular surface fluorescein staining score at D84
Time frame: 0 and 84 days
Mean change from Baseline (D0) in the study eye and D84 in the total ocular surface fluoresceine staining score
Evolution of DEQ-5 score
Time frame: 35 days
Evolution from Baseline of DEQ-5 questionnaire scores at day 35
Evolution of DEQ-5 score
Time frame: 84 days
Evolution from Baseline of DEQ-5 questionnaire scores at day 84
Evolution of Van Bijterveld score ( lissamine green staining)
Time frame: 35 Days
Mean change from Baseline ( D0) and D 35 in the total Van Bijterveld score
Evolution of Van Bijterveld score ( lissamine green staining)
Time frame: 84 days
Mean change from Baseline ( D0) and D 84 in the total Van Bijterveld score
Volume tear fluid secretion as assessed by schirmer test
Time frame: 35 days
Mean change from Baseline ( D0) in Volume tear fluid secretion as assessed
Volume tear fluid secretion as assessed by schirmer test
Time frame: 84 days
Mean change from Baseline ( D0) in Volume tear fluid secretion as assessed
Evolution of Tear film Break-Up Time
Time frame: 35 days
Mean change from Baseline (D0) in the study eye in TFBUT at Day 35
Evolution of Tear film Break-Up Time
Time frame: 84 days
Mean change from Baseline (D0) in the study eye in TFBUT at Day 84
Global sum score of dry eye symptoms at visit 3 - mean change from Baseline at visit 3 ( D35)
Time frame: 35 days
Mean change from Baseline in the global sum score of dry eye symptoms at D35 : discomfort,burning, stinging,eye dryness sensation, itching,foreign body sensation,photophobia, blurred vision.Each graded from 0 to 10
Global sum score of dry eye symptoms at visit 4 - mean change from Baseline at visit 3 ( D84)
Time frame: 84 days
Mean change from Baseline in the global sum score of dry eye symptoms at D84 : discomfort,burning, stinging,eye dryness sensation, itching,foreign body sensation,photophobia, blurred vision.Each graded from 0 to 10
Global treatment performance score assessed by the investigator at visit 3
Time frame: 35 days
Total Treatment performance score graded from 0 to 4
Global treatment performance score assessed by the investigator at visit 4
Time frame: 84 days
Total Treatment performance score graded from 0 to 4
Global treatment performance score assessed by the patient at visit 3
Time frame: 35 days
Total Treatment performance score graded from 0 to 4
Global treatment performance score assessed by the patient at visit 4
Time frame: 84 days
Total Treatment performance score graded from 0 to 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Individual participant dataSharing planned: Undecided. Depending on any journal publication of the results
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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.
Béatrice Cochener-Lamard, Prof principal investigator
Hôpital Morvan, Brest, France
Questions about this trial
What is this clinical trial studying?
A study testing Vismed gel Multi 0.3% eye drops and Vismed Multi 0.18% eye drops in people with Dry Eye, run by Horus Pharma.
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 13 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurore Garnier (0033483322078, aurore.garnier@horus-pharma.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the non-inferiority of Vismed® Gel Multi 0.3% in comparison with Vismed® Multi 0.18% in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment. (time frame: 35 days). The study lists 16 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 24 Aug 2018.