NCT06245421
Completed
Not Applicable
Multicentric, Randomized, Comparative Clinical Study on the Evaluation of the Efficacy and Safety of DM934 Versus Théalose on the Treatment of Moderate to Severe Ocular Dryness
ConditionsDry Eye
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dry Eye
- Sponsor
- Horus Pharma
- Enrollment
- 85
- Locations
- 5
- Primary Endpoint
- Cornea and conjunctiva staining (Oxford score)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study is a multicentric, comparative, randomized, investigator-blinded, parallel group study to demonstrate the non-inferiority of DM934 in comparison with Théalose in terms of cornea and conjunctiva staining (Oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject with a moderate to severe dry eye syndrome needing artificial tears in the 3 months preceding the inclusion.
- •Subject having used only artificial tears without preservative (NaCl 0.9%, Larmabak®) during 1 to 2 weeks before inclusion (up to 6 times a day) (given during wash-out period).
- •Subject with a score ≥ 18 for the OSDI (Ocular Surface Disease Index).
- •Subject with at least one eye with:
- •Global ocular staining (cornea and conjunctiva) ≥4 and ≤9 on the Oxford scale (0 to 15)
- •AND one of the following criteria:
- •Schirmer test ≥ 3 mm/5 min and ≤ 9 mm/5 min OR
- •Sum of 3 measurements of Tear film Break-Up Time (TBUT) ≤ 30s.
- •Subject, having given freely and expressly his/her informed consent.
- •Subject who is able to comply with the study requirements, as defined in the present CIP, at the Investigator's appreciation.
Exclusion Criteria
- •Far best corrected visual acuity \< 1/10 (according to Snellen Chart)
- •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
- •Subject with severe meibomian gland dysfunction (MGD).
- •History of ocular trauma, infection or inflammation, not related to dry eye syndrome within the last 3 months prior to the inclusion.
- •History of ocular allergy or ocular herpes within the last 12 months.
Outcomes
Primary Outcomes
Cornea and conjunctiva staining (Oxford score)
Time Frame: 35 days
Evaluation of the non-inferiority of DM934 in comparison with Théalose, in terms of cornea and conjunctiva staining (Oxford score), on worse eye
Secondary Outcomes
- Cornea and conjunctiva staining (Oxford score) (performance)(84 days)
- OSDI (questionnaire)(performance)(84 days)
- Van Bijsterveld score (performance)(84 days)
- Schirmer test (performance)(84 days)
- Global performance by the investigator (performance)(84 days)
- Global performance by the patient (performance)(84 days)
- Number of Adverse Events (safety)(84 days)
- Tear-Film Break Up Time (TBUT) (performance)(84 days)
- Dry eye symptoms (performance)(84 days)
Study Sites (5)
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