Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking

NCT ID: NCT02979054

Last Updated: 2019-10-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-03-31

Brief Summary

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

Detailed Description

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Conditions

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Keratoconus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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T4020

1 drop every other day during 5 days

Group Type EXPERIMENTAL

T4020

Intervention Type DEVICE

Saline solution

1 drop every other day during 5 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

Interventions

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T4020

Intervention Type DEVICE

Placebo

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoires Thea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital

Varna, , Bulgaria

Site Status

CHU

Clermont-Ferrand, , France

Site Status

Hospital

Vigo, , Spain

Site Status

Erciyes Üniversitesi Tıp Fakültesi

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Bulgaria France Spain Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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LT4020-302

Identifier Type: -

Identifier Source: org_study_id

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