Evaluation of Neovis® Total Multi Versus Systane® Balance on Ocular Dryness Associated With Meibomian Gland Dysfunction

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05191771
• Other study ID #: 21E1007
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dry Eye
• Meibomian Gland Dysfunction

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