Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-17

Study Completion Date

2025-01-06

Brief Summary

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The objective is to demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of the change from baseline (D1) in total ocular surface staining score assessed on Oxford 0-15 scale, in the study eye at the D36 visit.

The investigation is defined as a post-market stage. The clinical investigation design is confirmatory.

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Detailed Description

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Conditions

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Dry Eye Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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T2769

Hyaluronic acid, Trehalose, Naaga

Route of administration: topical, ocular use

Group Type EXPERIMENTAL

T2769

Intervention Type DEVICE

Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily.

Hylo-Forte®

Hyaluronic acid

Route of administration: topical, ocular use

Group Type ACTIVE_COMPARATOR

Hylo-Forte®

Intervention Type DEVICE

Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily.

Interventions

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T2769

Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily.

Intervention Type DEVICE

Hylo-Forte®

Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily.

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.
* Persistence of dry eye syndrome, despite artificial tears use in the previous month prior to the screening visit

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 letters Early Treatment Diabetic Retinopathy Study (ETDRS)).
* Patient with previous or current ophthalmic condition

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No