Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-10-31

Brief Summary

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The purpose of this study is to compare the efficacy and safety of T2762 versus Optive® in the treatment of moderate to severe Dry Eye Syndrome.

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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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T2762

One drop of T2762 in each eye 3 to 6 times daily

Group Type EXPERIMENTAL

T2762

Intervention Type DEVICE

One drop in each eye 3 to 6 times daily

Optive

One drop of Optive in each eye 3 to 6 times daily

Group Type ACTIVE_COMPARATOR

Optive

Intervention Type DEVICE

One drop in each eye 3 to 6 times daily

Interventions

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T2762

One drop in each eye 3 to 6 times daily

Intervention Type DEVICE

Optive

One drop in each eye 3 to 6 times daily

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Signed and dated informed consent.
* Male or female aged ≥ 18 years old.
* Diagnosis of moderate to severe dry eye syndrome

Exclusion Criteria

* Pregnancy, lactation.
* Childbearing potential woman who is not using a reliable method of contraception and is not surgically sterilised.
* Inability of patient to understand the study procedures and thus inability to give informed consent.
* Non-compliant patient
* Participation in another clinical study at the same time as the present study.
* Participation to the present study during the exclusion period of another clinical study.
* Already included once in this study.
* Ward of court.
* Patient not covered by government health care scheme

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No