Observational Study on the Efficacy and Tolerance of EYEB... | NCT05036954

Studies
Observational Study on the Efficacy and Tolerance of EYEBRID Lenses

NCT05036954

Sponsor

University Hospital, Caen

Status

Unknown status

Last Update Posted

Sep 8, 2021Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Contact Lens Complication

Interventions

EyeBrid Excel hybrid lenses

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2021Estimated

Primary Completion Date

Nov 30, 2021Estimated

Completion Date

Jul 30, 2022Estimated

First Submitted Date

Jun 12, 2021

First Submission Date that Met QC Criteria

Sep 2, 2021

First Posted Date

Sep 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2021

Last Update Posted Date

Sep 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Technical advances in lenses are continuous and materials are improved. We provide a prospective longitudinal observational study evaluating the efficacy and safety of new EyeBrid Excel hybrid lenses (LCS) in the treatment of severe ametropia and for patients with corneal irregularities.

This study should include 60 patients for a period of three months. The aim of this work is to assess the improvement in the best corrected visual acuity and the good tolerance of this lens.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Label	Type	Description	Intervention Names
no arm			Device: EyeBrid Excel hybrid lenses

Name	Type	Description	Arm Group Labels	Other Names
EyeBrid Excel hybrid lenses	Device	new lenses	no arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
tolerance assesment	scale of discomfort when using contact lenses	3 month

Secondary Outcomes

Measure	Description	Time Frame
Improvement of visual acuity	measurement of visual acuity by the ETDRS charts	3 month
Assessment and quantification of complications	note the number of abscesses

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

o Wear rigid lenses and complain about their lenses (discomfort, loss, poor vision) or
- Wear rigid lenses and have objective intolerances (damage to surfaces related to rigid lenses) or
- Are new wearers of lenses and presenting a strong ametropia (Strong myopia from -5.00 to -30.00d, strong hyperopia from + 4.50d to + 30.00d, strong astigmatism from 2.50d to 12.00d), with or without presbyopia (Addition of 0.75d to 3.50d)
Any patient diagnosed with Keratoconus stages 1 to 3.
Be affiliated to the social security system

Exclusion Criteria:

Patient with contraindications to wearing contact lenses
Pregnant or breastfeeding woman
Any minor or over 80 years old
Any infection, inflammation or abnormality of the anterior segments
Progressive ocular disorder of the anterior segments for which the wearing of contact lenses would be discouraged;
Use of systemic or ocular treatment products for which the wearing of contact lenses would be discouraged;
History of any herpetic keratitis;
History of any refractive surgery or any irregular cornea (except in cases where the contact lenses examined may be worn by a subject with an irregular cornea, suffering from keratoconus or having undergone refractive surgery);
Slit lamp observations of greater than grade 1 gravity;
Vascularization of the cornea with a penetration greater than 1 mm;
Case of pathological dry eye;
When a subject has participated in a clinical trial on contact lenses or contact lens care products within the past 30 days.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Contact lens wearers, cohort of 60 patients

Sampling Method

Non-Probability Sample