Observational Study on the Efficacy and Tolerance of EYEBRID Lenses

Contact Lens Complication Clinical Trial

— EYEBRID  

Official title:

Observational Study on the Efficacy and Tolerance of EYEBRID Lenses

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05036954
• Other study ID #: 21-0045
• Status: Not yet recruiting
• Start date: September 30, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: July 2021
• Source: University Hospital, Caen
• Contact: Jean-Claude Quintyn, MD, PhD
• Phone: 00 33 2 31 06 46 30
• Email: quintyn-jc[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 30, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contact Lens Complication

Intervention

Device:
• EyeBrid Excel hybrid lenses
new lenses

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tolerance assesment	scale of discomfort when using contact lenses	3 month
Secondary	Improvement of visual acuity	measurement of visual acuity by the ETDRS charts	3 month
Secondary	Assessment and quantification of complications	note the number of abscesses	3 month