Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome
Not Applicable
Terminated
- Conditions
- Dry Eye Syndrome
- Interventions
- Device: OptiveDevice: T2762
- Registration Number
- NCT02617095
- Lead Sponsor
- Laboratoires Thea
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 64
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Optive Optive One drop of Optive in each eye 3 to 6 times daily T2762 T2762 One drop of T2762 in each eye 3 to 6 times daily
- Primary Outcome Measures
Name Time Method Change of the symptomatology evaluation on a Visual Analogic Scale Day 28
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Laboratoires Théa
🇫🇷Clermont-Ferrand, France