Performance and Safety of T2769 in DED

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2024-08-15

Brief Summary

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To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total ocular surface staining (Oxford score) after 35 days of treatment.

To evaluate the performance and safety of T2769 versus Vismed® Multi.

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Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Change from baseline in the study eye at Day 36 in Global Ocular staining (decrease of oxford score = better outcome)

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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T2769

1 drop in each eye, 3 to 6 times daily

Group Type EXPERIMENTAL

T2769

Intervention Type DEVICE

T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.

Vismed® Multi

1 drop in each eye, 3 to 6 times daily

Group Type ACTIVE_COMPARATOR

Vismed® Multi

Intervention Type DEVICE

Hyaluronic acid

Interventions

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T2769

T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.

Intervention Type DEVICE

Vismed® Multi

Hyaluronic acid

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Informed consent signed and dated (obtained prior to initiating any procedures).
* Patient aged ≥18 years old.
* Known dry eye syndrome requiring artificial tears for at least the last 3 months prior to screening visit.
* Surface Disease Index (OSDI) Score ≥ 23.
* Ocular discomfort evaluated by VAS ≥ 40 mm.

Exclusion Criteria

* Far best-corrected visual acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 (ETDRS) letters Early Treatment Diabetic Retinopathy Study).
* Severe blepharitis according to the judgment of the investigator
* Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No