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NCT02617095 Clinical Trial

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

Dry Eye Syndrome Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02617095
Other study ID # LT2762-PIV-11/13
Secondary ID
Status Terminated
Phase N/A
First received November 26, 2015
Last updated March 6, 2017
Start date February 2015
Est. completion date October 2016

Study information
Verified date March 2017
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 64
Est. completion date October 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• T2762
One drop in each eye 3 to 6 times daily
• Optive
One drop in each eye 3 to 6 times daily

Locations
Country Name City State
France Laboratoires Théa Clermont-Ferrand

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires Thea

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of the symptomatology evaluation on a Visual Analogic Scale Day 28
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