NCT05036954

Unknown

Observational Study on the Efficacy and Tolerance of EYEBRID...

University Hospital, Caen Source

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Other study identifiers

Sponsor study identifier

21-0045

Study Type

observational

Estimated enrollment

60

Locations

1 country

Sites

1

Timeline

Study Start

September 30, 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

November 30, 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

July 30, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 60 participants
Study completion date: July 30, 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 12, 2021
Actual (reported)
First Posted
September 8, 2021
Actual (reported)
Study Start
September 30, 2021
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 30, 2021
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 30, 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: September 8, 2021
Status Verified: July 2021
Last Update Submitted: September 2, 2021

Conditions

Contact Lens Complication

Outcome Measures

Primary Outcomes (1)

tolerance assesment
scale of discomfort when using contact lenses
3 month

Secondary Outcomes (2)

Improvement of visual acuity
3 month
Assessment and quantification of complications
3 month

Study Arms (1)

no arm

Device: EyeBrid Excel hybrid lenses

Interventions

EyeBrid Excel hybrid lensesDevice

new lenses

no arm

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Contact lens wearers, cohort of 60 patients

You may qualify if:

o Wear rigid lenses and complain about their lenses (discomfort, loss, poor vision) or

Sponsors & Collaborators

University Hospital, Caen
Otherlead

Study Sites (1)

Caen University Hospital

Caen, 14033, France

Jean Claude QUINTYN, MD PhDCONTACT

Central Study Contacts

Jean-Claude Quintyn, MD, PhD

CONTACT

00 33 2 31 06 46 30 quintyn-jc@chu-caen.fr

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 12, 2021

First Posted

September 8, 2021

Study Start

September 30, 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

November 30, 2021

Estimated (date passed)

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Completed

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Phase 4Terminated

NCT05239494

Dailies Total 1 Sphere Contact Lenses

Not ApplicableCompleted

NCT03848221

Direct Application of Systane Complete to Contact Lenses

Phase 4Completed

NCT07001306

Long-term Effects of SCL-wearing on Corneal Neuromediators and Postoperative Rehabilitation After SMILE

Completed

NCT06392438

Cyclosporine and Intense Pulsed Light for Dry Eye in Contact Lens Users

Phase 3Unknown

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

July 30, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

September 8, 2021

Record last verified: 2021-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05036954
Data provider: ClinicalTrials.gov
Source updated: 2021-09-08
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:48 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

no arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations