NCT05298917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2022

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

March 16, 2022

Last Update Submit

January 24, 2023

Conditions

Cornea

Keywords

silicone hydrogel contact lensextended contact lens wearcorneal sensitivityesthesiometry

Outcome Measures

Primary Outcomes (1)

  • 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.

    7+/-1 days

Secondary Outcomes (1)

  • correlation between corneal sensitvity threshold and subjective symptoms

    7+/-1 days

Study Arms (1)

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

Device: silicone hydrogel contact lens

Interventions

silicone hydrogel contact lensDEVICE

silicone hydrogel contact lens

extended contact lens wear

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Optometry

Olten, Canton of Solothurn, 4600, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 15106930BACKGROUND

  • 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.

    PMID: 10421298BACKGROUND

  • 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.

    PMID: 33775377BACKGROUND

  • 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.

    PMID: 12697417BACKGROUND

  • 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.

    PMID: 35156726BACKGROUND

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Daniela Nosch, PhD

    Institute of Optometry, FHNW

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 16, 2022

First Posted

March 28, 2022

Study Start

April 1, 2022

Primary Completion

August 18, 2022

Study Completion

August 18, 2022

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)