Influence of Silicone Hydrogel Extended Contact Lens Wear on Corneal Sensitivity

January 24, 2023 updated by: Daniela Nosch
Soft contact lens wear reduces the amount of oxygen reaching the eye, which may have an influence on corneal sensitivity. The aim of this study is to measure corneal sensitivity with means of liquid jet esthesiometry at baseline and after 6 days of continuous, extended contact lens wear.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Contact lens wear may have an influence on corneal sensitivity, by three mechanisms: hypoxic, mechanical and inflammatory. Extended silicone hydrogel contact lens wear increases the risk of infections. A change in corneal sensitivity may be considered as an indicator for change in corneal physiology. It is there the aim of this study is to measure corneal sensitivity with means of liquid jet esthesiometry at baseline and after 6 days of continuous, extended contact lens wear.

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

  • Switzerland
    • Solothurn
      • Olten, Solothurn, Switzerland, 4600
        • Institute of Optometry

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • no contact lens wear three days before first visit
  • corneal radius between 7.4 and 8.0; if corneal radius >8.0, corneal diameter must be at least 12 mm; if corneal radius < 7.4, corneal diameter must be < 12.0
  • OSDI score no higher than 13 points

Exclusion Criteria:

  • systemic disease that may have an influence ocular healtjh
  • active ocular disease and no history of ocular surgery

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: extended contact lens wear
subjects wear silicone hydrogel contact lenses continuously for 7+/- 1 days - corneal sensitivity will be measured and compared at baseline versus after extended contact lens wear
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 7 days of extended contact lens wear
Time Frame: 7+/-1 days
The difference in corneal sensitivity threshold baseline versus after 7 days of extended contact lens wear will be determined. Corneal sensitivity measurement will take place with the Swiss Liquid Jet Aesthesiometer for Corneal Sensitivity (SLACS) and will be recorded in mbar.
7+/-1 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between corneal sensitvity threshold and subjective symptoms
Time Frame: 7+/-1 days
correlation between corneal sensitvity threshold and subjective symptoms after 7 days of extended contact lens wear: corneal sensitivity threshold will be determinded with the Swiss Liquid Jet Aesthesiometer for Corneal Sensitivity (SLACS) and will be recorded in mbar. Subjective Symptoms will be recorded with the CLEDQ8 questionnaire (specifically designed to assess contact lens comfort)
7+/-1 days

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 1, 2022

Primary Completion (Actual)

August 18, 2022

Study Completion (Actual)

August 18, 2022

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-D0011

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

product manufactured in and exported from the U.S.

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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