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

Thea Pharma

Status: Terminated

Conditions: Dry Eye Syndrome

Treatments: Device: T2762; Device: Optive

Study type: Interventional

Funder types: Industry

Identifiers

NCT02617095

LT2762-PIV-11/13

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

T2762

Experimental group

Description:

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

Treatment:

Device: T2762

Optive

Active Comparator group

Description:

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

Treatment:

Device: Optive