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Completed

NCT Number: NCT05298917

Influence of Silicone Hydrogel Extended Contact Lens Wear on Corneal Sensitivity

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.

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Key information

Conditions

Cornea Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Optometry

Olten, Canton of Solothurn, 4600, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

silicone hydrogel contact lens

Device

silicone hydrogel contact lens

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Daniela Nosch

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 28, 2022
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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