Status:
UNKNOWN
Evaluation of Neovis® Total Multi Versus Systane® Balance on Ocular Dryness Associated With Meibomian Gland Dysfunction
Lead Sponsor:
Horus Pharma
Conditions:
Dry Eye
Meibomian Gland Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05191771
Start Date
January 1 2022
End Date
December 1 2022
Last Update
January 13 2022
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