Influence of Silicone Hydrogel Contact Lens Neophyte Wear on Corneal Sensitivity

Last updated: February 23, 2024
Sponsor: Daniela Nosch
Overall Status: Completed

Phase

N/A

Condition

Allergy

Allergies & Asthma

Allergy (Pediatric)

Treatment

Device: silicone hydrogel contact lens

Clinical Study ID

NCT05745220
2022-D0124
  • Ages 18-38
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Soft contact lenses can affect the ocular surface and sometimes cause intolerance. The aim of this study is to measure corneal sensitivity using the Swiss Liquid Jet aesthesiometer at baseline, after one and after six weeks, in novice daily contact lens wearers.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The Ocular Surface Disease Index questionnaire (OSDI) score for dry eye classificationis ≤ 13
  • Participants must be candidates for contact lens wear.
  • Corneal radius between 7.4mm and 8.0mm
  • If the corneal radius is > 8.0mm, the corneal diameter must be greater than 12.0mm.
  • If the corneal radius is <7.4mm, the required corneal diameter is less than 12.0mm.
  • Participants have a CL cylindrical ametropia ≤ -1.25 D.
  • Participants will not have worn CL for 7 days prior to the start of the study.
  • Participants do not wear CL regularly (no more than 1 days per week) prior to thestart of the study.
  • During the study, the participant wore the CL a minimum of 5 days per week for aminimum of 8 hours.
  • The person being tested is in good health. This means that he or she does not sufferfrom any systemic diseases, such as diabetes or rheumatism, which could have aninfluence on eye health. He or she also has no eye disease and has not previouslyundergone corneal (refractive) surgery.

Exclusion

Exclusion Criteria:

  • The participant is a minor.
  • The participant has worn CL within the last 7 days.
  • The radius of the cornea is not within the prescribed range. In addition, the cornealdiameter is not within the prescribed range either.
  • The participant's ametropia is not within the prescribed range.
  • The participant has worn the lenses for less than 8 hours for less than five days.
  • The participant has no diagnosis of dry eye.
  • The OSDI questionnaire score for the Dry Eye classification is greater than 13.
  • The participant suffers from a systemic disease (diabetes or rheumatism) that couldinfluence ocular health, an ocular disease or has already undergone refractivesurgery.
  • Vulnerable participants

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: Device: silicone hydrogel contact lens
Phase:
Study Start date:
April 08, 2023
Estimated Completion Date:
September 30, 2023

Study Description

Contact lens discomfort is described by many wearers. Wearing contact lenses can influence corneal sensitivity through three mechanisms: hypoxic, mechanical and inflammatory. A change in corneal sensitivity can be considered an indicator of a change in corneal physiology. Corneal sensitivity plays a major role in maintaining eye health. The interest of this study is to test the variability of the corneal sensitivity threshold during a new adaptation of silicone hydrogel contact lenses, and to verify whether there is a correlation with the wearer's comfort. For that, corneal sensitivity threshold measurements are taken at the baseline and then after one and six weeks of daily contact lens wear. The measurement is performed with the Swiss Liquid Jet aesthesiometer for corneal sensitivity (SLACS). After one week and six weeks of daily lens wear, participants complete a Contact Lens Dry Eye Questionnaire (CLDEQ-8) for comfort analysis.

Connect with a study center

  • Optique Messerli Optometry centre

    Marly, Fribourg 1723
    Switzerland

    Site Not Available

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