NCT03874429

Brief Summary

The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

March 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 24, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2021

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

November 1, 2023

Completed
Last Updated

November 1, 2023

Status Verified

June 1, 2022

Enrollment Period

1.8 years

First QC Date

March 12, 2019

Results QC Date

June 14, 2022

Last Update Submit

October 31, 2023

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

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

    Change from baseline in the worse eye at Day 35 in Global Ocular staining (decrease of oxford score = better outcome)

    Baseline and Day 35

Study Arms (2)

T2259

EXPERIMENTAL

1 drop in each eye 2 to 4 times daily

Device: T2259

Vismed Multi

ACTIVE COMPARATOR

1 drop in each eye 2 to 4 times daily

Device: Vismed multi

Interventions

T2259DEVICE

Sodium Hyaluronate and Trehalose

Also known as: Sodium Hyaluronate and Trehalose
T2259
Vismed multiDEVICE

HA

Also known as: Sodium Hyaluronate
Vismed Multi

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:

  • Far best-corrected visual acuity≤2/10
  • Severe Blepharitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

C.H.N.O des XV-XX

Paris, 75012, France

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Corentin Le Camus
Organization
Laboratoires Thea
corentin.lecamus@theapharma.com
0680382020

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 14, 2019

Study Start

April 24, 2019

Primary Completion

February 12, 2021

Study Completion

March 25, 2021

Last Updated

November 1, 2023

Results First Posted

November 1, 2023

Record last verified: 2022-06

Locations

FR(1)