Comparison of the Efficacy and Safety of T2762 Versus Opt... | NCT02617095

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

NCT02617095

Sponsor

Laboratoires Thea

Status

Terminated

Last Update Posted

Mar 8, 2017Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Dry Eye Syndrome

Interventions

T2762
Optive

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment rate too slow

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Jun 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Nov 26, 2015

First Submission Date that Met QC Criteria

Nov 26, 2015

First Posted Date

Nov 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2017

Last Update Posted Date

Mar 8, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
T2762	Experimental	One drop of T2762 in each eye 3 to 6 times daily	Device: T2762
Optive	Active Comparator	One drop of Optive in each eye 3 to 6 times daily	Device: Optive

Interventions

Name	Type	Description	Arm Group Labels	Other Names
T2762	Device	One drop in each eye 3 to 6 times daily	T2762
Optive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of the symptomatology evaluation on a Visual Analogic Scale		Day 28

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank Larkin, Professor	Moorfields Eye Hospital -162 city road - London	Principal Investigator
Friedrich KRUSE, Professor	Augenklinik mit Poliklinik - Swabachanlage 6 - 91054 Erlangen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratoires Théa		Clermont-Ferrand		63000	France

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided