NCT02979054

Brief Summary

The purpose of this study is to assess the performance and safety of T4020 versus saline solution.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
4 countries

4 active sites

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

November 9, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

October 7, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

1.2 years

First QC Date

November 9, 2016

Results QC Date

July 16, 2019

Last Update Submit

October 11, 2019

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3

    Day 3

  • Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4

    Day 4

Secondary Outcomes (2)

  • Corneal Epithelial Defect Size Assessment

    Baseline and Day 5

  • Number of Participants With Treatment-emergent Adverse Events

    Through study completion, an average of 1 month

Study Arms (2)

T4020

EXPERIMENTAL

1 drop every other day during 5 days

Device: T4020

Saline solution

PLACEBO COMPARATOR

1 drop every other day during 5 days

Device: Placebo

Interventions

T4020DEVICE
T4020
PlaceboDEVICE
Saline solution

Eligibility Criteria

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

You may qualify if:

  • Adult patients diagnosed with progressive keratoconus
  • Patients who signed and dated informed consent

You may not qualify if:

  • Patient under 18 years
  • History within 1 month or any active ocular infection, ocular injury, and associated corneal ulceration and abscess
  • Corneal thickness\< 400µm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital

Varna, Bulgaria

Location

CHU

Clermont-Ferrand, 63000, France

Location

Hospital

Vigo, Spain

Location

Erciyes Üniversitesi Tıp Fakültesi

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Results Point of Contact

Title
Clinical Development Director
Organization
Laboratoires Théa
Corentin.LECAMUS@theapharma.com
+33(0)473981414

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2016

First Posted

December 1, 2016

Study Start

December 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

October 22, 2019

Results First Posted

October 7, 2019

Record last verified: 2019-10

Locations

BU(1)TU(1)FR(1)ES(1)