Back to resultsComparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome
Primary Purpose
Dry Eye Syndrome
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
T2762
Optive
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome
Eligibility Criteria
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
Sites / Locations
- Laboratoires Théa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
T2762
Optive
Arm Description
One drop of T2762 in each eye 3 to 6 times daily
One drop of Optive in each eye 3 to 6 times daily
Outcomes
Primary Outcome Measures
Change of the symptomatology evaluation on a Visual Analogic Scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02617095
Brief Title
Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome
Official Title
Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
recruitment rate too slow
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Thea
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T2762
Arm Type
Experimental
Arm Description
One drop of T2762 in each eye 3 to 6 times daily
Arm Title
Optive
Arm Type
Active Comparator
Arm Description
One drop of Optive in each eye 3 to 6 times daily
Intervention Type
Device
Intervention Name(s)
T2762
Intervention Description
One drop in each eye 3 to 6 times daily
Intervention Type
Device
Intervention Name(s)
Optive
Intervention Description
One drop in each eye 3 to 6 times daily
Primary Outcome Measure Information:
Title
Change of the symptomatology evaluation on a Visual Analogic Scale
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Larkin, Professor
Organizational Affiliation
Moorfields Eye Hospital -162 city road - London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Friedrich KRUSE, Professor
Organizational Affiliation
Augenklinik mit Poliklinik - Swabachanlage 6 - 91054 Erlangen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratoires Théa
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome
We'll reach out to this number within 24 hrs