Influence of Silicone Hydrogel Contact Lens Neophyte Wear on Corneal Sensitivity (CSCL)

February 23, 2024 updated by: Daniela Nosch

Corneal Sensitivity in Silicone Hydrogel Contact Lens Wear

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Daniela Nosch, PhD

Study Locations

  • Switzerland
    • Fribourg
      • Marly, Fribourg, Switzerland, 1723
        • Optique Messerli Optometry centre
        • Contact:
        • Sub-Investigator:
          • Marion Seghetti, BSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Daily contact lens wear
Participant wear silicone hydrogel contact lenses daily for 6 weeks ±2 days for a minimum wearing time of 5 days per week and 8 hours per day - corneal sensitivity will be measured and compared at baseline versus after 7±2 days and 5 weeks ±2 days daily contact lens wear.
Other: Device: silicone hydrogel contact lens
Silicone hydrogel contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in corneal sensitivity threshold baseline and after one and six weeks of daily contact lens wear
Time Frame: 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.
7±2 days and 5 weeks ±2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between corneal sensitivity threshold and subjective symptoms
Time Frame: 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)
7±2 days and 5 weeks ±2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniela Nosch

Investigators

  • Principal Investigator: Daniela Nosch, PhD, Institute of Optometry, FHNW

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-D0124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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