NCT02023268

Brief Summary

Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 6, 2016

Completed
Last Updated

August 24, 2017

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

December 23, 2013

Results QC Date

March 8, 2016

Last Update Submit

August 22, 2017

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

  • Global Ocular Staining (With Oxford Scale - Ranges : 0-15)

    Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome) Global Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed).

    Baseline and Day 35

Study Arms (2)

T2762

EXPERIMENTAL
Device: T2762

Vismed®

ACTIVE COMPARATOR
Device: Vismed®

Interventions

T2762DEVICE

1 drop in each eye 3 to 6 times daily during 84 days

T2762
Vismed®DEVICE

1 drop in each eye 3 to 6 times daily during 84 days

Vismed®

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 from ≥ 18 years old.
  • Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection.

You may not qualify if:

  • Best far corrected visual acuity \< 1/10
  • Severe blepharitis
  • Severe Dry Eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Dr Pascale Pouliquen
Organization
Laboratoires Théa
p.pouliquen@laboratoires-thea.fr
04 73 98 14 36

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2013

First Posted

December 30, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

August 24, 2017

Results First Posted

April 6, 2016

Record last verified: 2015-11

Locations

FR(1)