Observational Study on the Efficacy and Tolerance of EYEBRID Lenses (EYEBRID)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Contact Lens Complication
• Intervention / Treatment: Device: EyeBrid Excel hybrid lenses

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Jean-Claude Quintyn, MD, PhD; Phone Number: 00 33 2 31 06 46 30; Email: quintyn-jc@chu-caen.fr

Study Locations

• France
  • Caen, France, 14033
    • CAEN University Hospital
    • Contact: Jean Claude QUINTYN, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Contact lens wearers, cohort of 60 patients

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
no arm	Device: EyeBrid Excel hybrid lenses; new lenses

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	3 month

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Anticipated): September 30, 2021
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: June 12, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 21-0045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No