Observational Study on the Efficacy and Tolerance of EYEBRID Lenses

NCT05036954 | Unknown

• 1 other identifier: 21-0045
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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 lenses DEVICE

new lenses

no arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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
• 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.

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, 14033, France

Location

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
• Primary Completion: November 30, 2021
• Study Completion: July 30, 2022
• Last Updated: September 8, 2021

Record last verified: 2021-07

Locations

FR (1)