Influence of Silicone Hydrogel Contact Lens Neophyte Wear on Corneal Sensitivity

Not Applicable

Completed

• Conditions: Cornea

• Registration Number: NCT05745220
• Lead Sponsor: Daniela Nosch

Brief Summary

Soft contact lenses can affect the ocular surface and sometimes cause intolerance. The aim of this study is to measure corneal sensitivity using the Swiss Liquid Jet aesthesiometer at baseline, after one and after six weeks, in novice daily contact lens wearers.

Detailed Description

Contact lens discomfort is described by many wearers. Wearing contact lenses can influence corneal sensitivity through three mechanisms: hypoxic, mechanical and inflammatory. A change in corneal sensitivity can be considered an indicator of a change in corneal physiology. Corneal sensitivity plays a major role in maintaining eye health. The interest of this study is to test the variability of the corneal sensitivity threshold during a new adaptation of silicone hydrogel contact lenses, and to verify whether there is a correlation with the wearer's comfort. For that, corneal sensitivity threshold measurements are taken at the baseline and then after one and six weeks of daily contact lens wear. The measurement is performed with the Swiss Liquid Jet aesthesiometer for corneal sensitivity (SLACS). After one week and six weeks of daily lens wear, participants complete a Contact Lens Dry Eye Questionnaire (CLDEQ-8) for comfort analysis.

Study Timeline

• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-27
• Study Start: 2023-04-08
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• The Ocular Surface Disease Index questionnaire (OSDI) score for dry eye classification is ≤ 13
• Participants must be candidates for contact lens wear.
• Corneal radius between 7.4mm and 8.0mm
• If the corneal radius is > 8.0mm, the corneal diameter must be greater than 12.0mm.
• If the corneal radius is <7.4mm, the required corneal diameter is less than 12.0mm.
• Participants have a CL cylindrical ametropia ≤ -1.25 D.
• Participants will not have worn CL for 7 days prior to the start of the study.
• Participants do not wear CL regularly (no more than 1 days per week) prior to the start of the study.
• During the study, the participant wore the CL a minimum of 5 days per week for a minimum of 8 hours.
• The person being tested is in good health. This means that he or she does not suffer from any systemic diseases, such as diabetes or rheumatism, which could have an influence on eye health. He or she also has no eye disease and has not previously undergone corneal (refractive) surgery.

Exclusion Criteria

• The participant is a minor.
• The participant has worn CL within the last 7 days.
• The radius of the cornea is not within the prescribed range. In addition, the corneal diameter is not within the prescribed range either.
• The participant's ametropia is not within the prescribed range.
• The participant has worn the lenses for less than 8 hours for less than five days.
• The participant has no diagnosis of dry eye.
• The OSDI questionnaire score for the Dry Eye classification is greater than 13.
• The participant suffers from a systemic disease (diabetes or rheumatism) that could influence ocular health, an ocular disease or has already undergone refractive surgery.
• Vulnerable participants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Difference in corneal sensitivity threshold baseline and after one and six weeks of daily contact lens wear	7±2 days and 5 weeks ±2	Comparison of corneal sensitivity threshold at the baseline and after one and six weeks of daily wear of silicone hydrogel contact lenses on neophyte wearer. Corneal sensitivity measurement will take place with the Swiss Liquid Jet Aesthesiometer for Corneal Sensitivity (SLACS) and will be recorded in mbar.

Secondary Outcome Measures

Name	Time	Method
Correlation between corneal sensitivity threshold and subjective symptoms	7±2 days and 5 weeks ±2	Correlation between corneal sensitivity threshold and subjective symptoms after one and six weeks of daily contact lens wear: corneal sensitivity threshold will be determined with the Swiss Liquid Jet Aesthesiometer for Corneal Sensitivity (SLACS) and will be recorded in mbar. Subjective Symptoms will be recorded with the Contact Lens Dry Eye Questionnaire (CLDEQ-8) scored from 0=comfortable to 37=uncomfortable (specifically designed to assess contact lens comfort)

Trial Locations

Locations (1)

Optique Messerli Optometry centre; 🇨🇭 Marly, Fribourg, Switzerland