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Clinical Trials/NCT05298917
NCT05298917CompletedNot Applicable

Influence of Silicone Hydrogel Extended Contact Lens Wear on Corneal Sensitivity

Daniela Nosch1 site in 1 country30 target enrollmentStarted: April 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
difference in corneal sensitivity threshold baseline and after 7 days of extended contact lens wear

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

extended contact lens wear

Other

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

Intervention: silicone hydrogel contact lens (Device)

Outcomes

Primary Outcomes

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

  • correlation between corneal sensitvity threshold and subjective symptoms(7+/-1 days)

Investigators

Sponsor
Daniela Nosch
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Daniela Nosch

Clinical Professor

University of Applied Sciences and Arts Northwestern Switzerland

Study Sites (1)

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