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Influence of Silicone Hydrogel Extended Contact Lens Wear on Corneal Sensitivity

Primary Purpose

Cornea

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

silicone hydrogel contact lens

About this trial

This is an interventional other trial for Cornea focused on measuring silicone hydrogel contact lens, extended contact lens wear, corneal sensitivity, esthesiometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Institute of Optometry

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

extended contact lens wear

Arm Description

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

Outcomes

Primary Outcome Measures

difference in corneal sensitivity threshold baseline and after 7 days of extended contact lens wear

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 Outcome Measures

correlation between corneal sensitvity threshold and subjective symptoms

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)

Full Information

NCT ID

NCT05298917

First Posted

March 16, 2022

Last Updated

January 24, 2023

Sponsor

Daniela Nosch

1. Study Identification

Unique Protocol Identification Number

NCT05298917

Brief Title

Influence of Silicone Hydrogel Extended Contact Lens Wear on Corneal Sensitivity

Official Title

Influence of Silicone Hydrogel Extended Contact Lens Wear on Corneal Sensitivity

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

April 1, 2022 (Actual)

Primary Completion Date

August 18, 2022 (Actual)

Study Completion Date

August 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Daniela Nosch

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cornea

Keywords

silicone hydrogel contact lens, extended contact lens wear, corneal sensitivity, esthesiometry

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

extended contact lens wear

Arm Type

Other

Arm Description

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 Type

Device

Intervention Name(s)

silicone hydrogel contact lens

Intervention Description

silicone hydrogel contact lens

Primary Outcome Measure Information:

Title

difference in corneal sensitivity threshold baseline and after 7 days of extended contact lens wear

Description

Time Frame

7+/-1 days

Secondary Outcome Measure Information:

Title

correlation between corneal sensitvity threshold and subjective symptoms

Description

Time Frame

7+/-1 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniela Nosch, PhD

Organizational Affiliation

Institute of Optometry, FHNW

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Optometry

City

Olten

State/Province

Solothurn

ZIP/Postal Code

4600

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15106930

Citation

Belmonte C, Acosta MC, Gallar J. Neural basis of sensation in intact and injured corneas. Exp Eye Res. 2004 Mar;78(3):513-25. doi: 10.1016/j.exer.2003.09.023.

Results Reference

background

PubMed Identifier

10421298

Citation

Cheng KH, Leung SL, Hoekman HW, Beekhuis WH, Mulder PG, Geerards AJ, Kijlstra A. Incidence of contact-lens-associated microbial keratitis and its related morbidity. Lancet. 1999 Jul 17;354(9174):181-5. doi: 10.1016/S0140-6736(98)09385-4.

Results Reference

background

PubMed Identifier

33775377

Citation

Morgan PB, Murphy PJ, Gifford KL, Gifford P, Golebiowski B, Johnson L, Makrynioti D, Moezzi AM, Moody K, Navascues-Cornago M, Schweizer H, Swiderska K, Young G, Willcox M. CLEAR - Effect of contact lens materials and designs on the anatomy and physiology of the eye. Cont Lens Anterior Eye. 2021 Apr;44(2):192-219. doi: 10.1016/j.clae.2021.02.006. Epub 2021 Mar 25.

Results Reference

background

PubMed Identifier

12697417

Citation

Muller LJ, Marfurt CF, Kruse F, Tervo TM. Corneal nerves: structure, contents and function. Exp Eye Res. 2003 May;76(5):521-42. doi: 10.1016/s0014-4835(03)00050-2. Erratum In: Exp Eye Res. 2003 Aug;77(2):253.

Results Reference

background

PubMed Identifier

35156726

Citation

Nosch DS, Oscity M, Steigmeier P, Kaser E, Loepfe M, Joos RE. Working principle and relevant physical properties of the Swiss Liquid Jet Aesthesiometer for Corneal Sensitivity (SLACS) evaluation. Ophthalmic Physiol Opt. 2022 May;42(3):609-618. doi: 10.1111/opo.12962. Epub 2022 Feb 14.

Results Reference

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Influence of Silicone Hydrogel Extended Contact Lens Wear on Corneal Sensitivity

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