NCT02617095

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

March 8, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

November 26, 2015

Last Update Submit

March 6, 2017

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change of the symptomatology evaluation on a Visual Analogic Scale

    Day 28

Study Arms (2)

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

T2762DEVICE

One drop in each eye 3 to 6 times daily

T2762
OptiveDEVICE

One drop in each eye 3 to 6 times daily

Optive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed and dated informed consent.
  • Male or female aged ≥ 18 years old.
  • Diagnosis of moderate to severe dry eye syndrome

You may not qualify if:

  • 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.
  • Already included once in this study.
  • Ward of court.
  • Patient not covered by government health care scheme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoires Théa

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Frank Larkin, Professor

    Moorfields Eye Hospital -162 city road - London

    PRINCIPAL INVESTIGATOR

  • Friedrich KRUSE, Professor

    Augenklinik mit Poliklinik - Swabachanlage 6 - 91054 Erlangen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2015

First Posted

November 30, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2016

Study Completion

October 1, 2016

Last Updated

March 8, 2017

Record last verified: 2017-03

Locations

FR(1)