Ocular Surface in Patients With Soft Contact Lenses

Ocular Surface Clinical Trial

— E2LC  

Official title:

Ocular Surface in Patients With Soft Contact Lenses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04244643
• Other study ID #: IRBN922019/CHUSTE
• Status: Recruiting
• Start date: December 18, 2019
• Est. completion date: December 2020

Study information

• Verified date: December 2019
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Marie Caroline TRONE
• Phone: 04 77 82 94 28
• Email: m.caroline.trone[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Contact lenses modify the structure of the tear film by biophysical and biochemical interactions. These changes may explain more common dry eye symptoms and may sometimes cause lens failure or discontinuation.

In recent years, the investigators have various objective non-invasive methods of tear film evaluation such as the non-invasive break up time, interferometry, and tears meniscus height. These measurements are performed in clinical practice during consultation by devices such as LACRYDIAG.

The improvement of lens comfort requires a better knowledge of the ocular surface in patients with contact lenses. But currently none of these objective parameters have been accurately described.

Therefore, the investigators would like to build a database to describe the different parameters of ocular surface in patients with soft contact lenses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with soft contact lenses

• Patients with their contact lenses on the eyes at the time of the examination and having undergone a LACRYDIAG examination

• Only Right eye analyze

Exclusion Criteria:

• Patients with rigid contact lenses

• Patients not wearing their lenses at the time of the examination

Related Conditions & MeSH terms

• Ocular Surface

Intervention

Other:
• data collection
Data collected from patient records Demographic data: date of birth, sex, city of birth Contact lenses: laboratory, brand, model, wearing time before the exam, opening date of the blister, solution of contact lenses, material, renewal time Refraction Dry eye disease: Ocular Surface Disease Index (OSDI) score LACRYDIAG data: Non-Invasive Break-Up Time (NIBUT), interferometry and tears meniscus height

Locations

Country	Name	City	State
France	Cabinet médico-chirurgical de l'Alcazar	Beausoleil
France	Cabinet du Dr Virginie MADARIAGA	Blagnac
France	Point Vision Bordeaux	Bordeaux
France	Cabinet du Dr Françoise LE CHERPIE	Draguignan
France	Cabinet du Dr Hélène Bertrand	Lille
France	Cabinet du Dr Cyrille TEMSTET	Paris
France	Centre hospitalier national d'ophtalmologie des Quinze-Vingts	Paris
France	Centre ophtalmologique Saint-Paul	Paris
France	Point Vision Paris Royale	Paris
France	CHU de Saint Etienne	Saint Etienne
France	Point Vision Nice - St Laurent du Var	Saint-Laurent-du-Var
France	Clinique St Jean Languedoc	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Société Française des Ophtalmologistes Adaptateurs de Lentilles de Contact

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eye surface condition	presence or not : dry eye, allergies, blepharitis, corneal abscess, corneal ulceration, corneal neovascularization, chronic inflammatory conjunctivitis and others	baseline
Secondary	refraction	measured with vision tests	baseline
Secondary	Ocular Surface Disease Index score	is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning.; The overall OSDI score defined the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.	baseline
Secondary	non-invasive tear break-up time	with LACRYDIAG	baseline
Secondary	interferometry	with LACRYDIAG. Qualitative & quantitative analysis of the lipid layer.	baseline
Secondary	tears meniscus height	with LACRYDIAG	baseline