Dry Eye Clinical Trial
Official title:
Multicentric, Randomized, Comparative Clinical Study on the Evaluation of the Efficacy and Safety of Neovis® Total Multi Versus Systane® Balance on the Treatment of Ocular Dryness Associated With Meibomian Gland Dysfunction
This study is a multicentric, comparative, randomized, investigator-blinded, in parallel groups study to demonstrate the non-inferiority of Neovis® Total Multi in comparison with Systane® Balance, in terms of improvement of stability of Tear film in patients with eye dryness associated to meibomian gland dysfunction, after 28 days of treatment.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | December 2022 |
Est. primary completion date | October 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Presenting dry eye symptoms for at least 6 months. - OSDI (Ocular Surface Disease Index) = 18 - At least one eye eligible with: - sum of peripheral corneal and conjunctival staining = 4 and = 9 (Oxford 0-15 grading scheme) AND - sum of 3 measurements of Tear film Break-Up Time (TBUT) = 15s - Meibomian Gland Dysfunction on at least one eye (same eye eligible) with a score of 1 or higher for meibum quality score (from 0: clear to 3: toothpaste/obstruction) and evidence of partial or whole missing Meibomian Glands. - Ability and willingness to apply eyelid hygiene during the whole study, including wash-out period. - Having given freely and expressly his/her informed consent. - 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. Exclusion Criteria: - 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. - Use of contact lenses in either eye 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 - History of ocular traumatism, ocular infection or ocular inflammation within the last 3 months. - 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. - Use of the following ocular treatments: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus during the month preceding the inclusion. - IOP > 21 mmHg - Uncontrolled systemic disease - Alcohol abuse - Psychiatric disorders - Cognitive impairment that could affect evaluation of preferences or inability to understand written patient information - Participation in other clinical studies in the last month - Hypersensitivity to one or more components of the study product - Dry eye due to systemic disease, concomitant medication, malign conditions or idiopathic causes - Punctual plugs during the past 3 months - Use of lipid-containing eye drops during the past 3 months - Use of other therapeutic ophthalmics during the past 3 months - Earlier participation at this clinical trial or the patient being an investigator or a member of the personnel involved at this clinical trial |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Horus Pharma |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Non-Invasive Tear film Break-Up Time (NIBUT) (exploratory, optional) | Main change from baseline of Non-Invasive Tear film Break-Up Time (NIBUT) in the worse eye and contralateral eye | 28 days | |
Other | Non-Invasive Tear film Break-Up Time (NIBUT) (exploratory, optional) | Main change from baseline of Non-Invasive Tear film Break-Up Time (NIBUT) in the worse eye and contralateral eye | 84 days | |
Other | Lipid layer thickness (exploratory, optional) | Main change from baseline of lipid layer thickness with interferometry methods in the worse eye and contralateral eye | 28 days | |
Other | Lipid layer thickness (exploratory, optional) | Main change from baseline of lipid layer thickness with interferometry methods in the worse eye and contralateral eye | 84 days | |
Other | Functional visual acuity (exploratory, optional) | Main change from baseline of functional visual acuity in the worse eye and contralateral eye | 28 days | |
Other | Functional visual acuity (exploratory, optional) | Main change from baseline of functional visual acuity in the worse eye and contralateral eye | 84 days | |
Other | Super Oxyde Dismutase (SOD) dosage (exploratory, optional) | Main change from baseline of SOD1 and SOD2 in the worse eye | 84 days | |
Other | Goblet cells analysis (exploratory, optional) | Main change from baseline of Goblet cells in the worse eye | 84 days | |
Primary | Tear-Film Break Up Time (TBUT) | Evaluation of the non-inferiority of Neovis® Total Multi in comparison with Systane® Balance, in terms of TBUT improvement, on worse eye | 28 days | |
Secondary | Tear-Film Break Up Time (TBUT) (performance) | Main change from baseline of Tear-Film Break Up Time (TBUT) in the worse eye and contralateral eye | 84 days | |
Secondary | Cornea and conjunctiva staining (Oxford score) (performance) | Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye | 28 days | |
Secondary | Cornea and conjunctiva staining (Oxford score) (performance) | Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye | 84 days | |
Secondary | Meibomian gland expression (performance) | Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye | 28 days | |
Secondary | Meibomian gland expression (performance) | Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye | 84 days | |
Secondary | Meibum quality (performance) | Main change from baseline of meibum quality score in the worse eye and contralateral eye | 28 days | |
Secondary | Meibum quality (performance) | Main change from baseline of meibum quality score in the worse eye and contralateral eye | 84 days | |
Secondary | Meiboscopy (performance) | Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye | 28 days | |
Secondary | Meiboscopy (performance) | Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye | 84 days | |
Secondary | Eyelid margin abnormalities (performance) | Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye | 28 days | |
Secondary | Eyelid margin abnormalities (performance) | Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye | 84 days | |
Secondary | OSDI (questionnaire) (performance) | Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye | 28 days | |
Secondary | OSDI (questionnaire) (performance) | Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye | 84 days | |
Secondary | Global performance by the investigator (performance) | Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 28 days | |
Secondary | Global performance by the investigator (performance) | Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 84 days | |
Secondary | Global performance by the patient (performance) | Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 28 days | |
Secondary | Global performance by the patient (performance) | Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 84 days | |
Secondary | Global tolerance by the investigator (safety) | Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 28 days | |
Secondary | Global tolerance by the investigator (safety) | Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 84 days | |
Secondary | Global tolerance by the patient (safety) | Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 28 days | |
Secondary | Global tolerance by the patient (safety) | Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 84 days | |
Secondary | Intensity of ocular symptoms upon instillation (safety) | Evaluation of intensity of ocular symptoms upon instillation on a scale from 0 (none) to 3 (severe) | 28 days | |
Secondary | Intensity of ocular symptoms upon instillation (safety) | Evaluation of intensity of ocular symptoms upon instillation on a scale from 0 (none) to 3 (severe) | 84 days | |
Secondary | Duration of ocular symptoms upon instillation (safety) | Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours | 28 days | |
Secondary | Duration of ocular symptoms upon instillation (safety) | Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours | 84 days | |
Secondary | Frequency of ocular symptoms upon instillation (safety) | Evaluation of frequency of ocular symptoms upon instillation on a scale from 1 (rarely) to 4 (very often) | 28 days | |
Secondary | Frequency of ocular symptoms upon instillation (safety) | Evaluation of frequency of ocular symptoms upon instillation on a scale from 1 (rarely) to 4 (very often) | 84 days | |
Secondary | Number of Adverse Events | Collection of ocular and systemic adverse events | 84 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06159569 -
Performance and Tolerability of the Medical Device LACRIACT
|
N/A | |
Completed |
NCT05027087 -
The Effect of a Novel Blueberry Supplement on Dry Eye Disease
|
Phase 3 | |
Completed |
NCT05102409 -
An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease
|
Phase 2 | |
Completed |
NCT04081610 -
Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution
|
Phase 1 | |
Completed |
NCT05062564 -
Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye
|
N/A | |
Completed |
NCT05825599 -
PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms
|
N/A | |
Completed |
NCT03418727 -
Dry Eye Disease Study With Brimonidine
|
Phase 2 | |
Active, not recruiting |
NCT04425551 -
Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction
|
N/A | |
Recruiting |
NCT04527887 -
Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)
|
Phase 4 | |
Not yet recruiting |
NCT06379685 -
Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.
|
Phase 1 | |
Active, not recruiting |
NCT05618730 -
Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B
|
Phase 1 | |
Completed |
NCT04553432 -
Dry Eye OmniLenz Application of Omnigen Research Study
|
Phase 4 | |
Recruiting |
NCT04109170 -
Dry Eye Evaluation System Based on Bioinformatics
|
||
Completed |
NCT04105842 -
Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type
|
N/A | |
Completed |
NCT05505292 -
Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
|
Phase 4 | |
Completed |
NCT04668131 -
Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease
|
N/A | |
Completed |
NCT06176651 -
Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
|
Phase 4 | |
Completed |
NCT02235259 -
Efficacy and Safety of XG-104 for the Treatment of Dry Eye
|
Phase 2 | |
Not yet recruiting |
NCT02218827 -
Topical Steroid Treatment For Dry Eye
|
N/A | |
Completed |
NCT01959854 -
Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye
|
N/A |