NCT05191771
Unknown
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dry Eye
- Sponsor
- Horus Pharma
- Enrollment
- 120
- Primary Endpoint
- Tear-Film Break Up Time (TBUT)
- Last Updated
- 4 years ago
Overview
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 terms of improvement of stability of Tear film in patients with eye dryness associated to meibomian gland dysfunction, after 28 days of treatment.
Investigators
Eligibility Criteria
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.
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/
- •Subject with severe ocular dryness with one of these conditions:
- •Eyelid or blinking malfunction
- •Corneal disorders not related to dry eye syndrome
- •Ocular metaplasia
Outcomes
Primary Outcomes
Tear-Film Break Up Time (TBUT)
Time Frame: 28 days
Evaluation of the non-inferiority of Neovis® Total Multi in comparison with Systane® Balance, in terms of TBUT improvement, on worse eye
Secondary Outcomes
- Eyelid margin abnormalities (performance)(84 days)
- OSDI (questionnaire) (performance)(84 days)
- Meibomian gland expression (performance)(84 days)
- Meibum quality (performance)(84 days)
- Meiboscopy (performance)(84 days)
- Tear-Film Break Up Time (TBUT) (performance)(84 days)
- Cornea and conjunctiva staining (Oxford score) (performance)(84 days)
- Global performance by the patient (performance)(84 days)
- Global tolerance by the patient (safety)(84 days)
- Number of Adverse Events(84 days)
- Global performance by the investigator (performance)(84 days)
- Global tolerance by the investigator (safety)(84 days)
- Intensity of ocular symptoms upon instillation (safety)(84 days)
- Duration of ocular symptoms upon instillation (safety)(84 days)
- Frequency of ocular symptoms upon instillation (safety)(84 days)
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