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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05191771
Other study ID # 21E1007
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2022
Est. completion date December 2022

Study information

Verified date January 2022
Source Horus Pharma
Contact Laure Chauchat
Phone +33 (0)4 89 08 90 98
Email laure.chauchat@horus-pharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Neovis Total Multi
1 drop in each eye, 4 times per day
Systane Balance
1 drop in each eye, 4 times per day

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Horus Pharma

Outcome

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
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