Influence of Silicone Hydrogel Contact Lens Neophyte Wear on Corneal Sensitivity

NCT05745220 | Completed

• 1 other identifier: 2022-D0124
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cornea

Keywords

silicone hydrogel contact lens; daily contact lens wear; corneal sensitivity; esthesiometry

Outcome Measures

Primary Outcomes (1)

• Difference in corneal sensitivity threshold baseline and after one and six weeks of daily contact lens wear

  Comparison of corneal sensitivity threshold at the baseline and after one and six weeks of daily wear of silicone hydrogel contact lenses on neophyte wearer. Corneal sensitivity measurement will take place with the Swiss Liquid Jet Aesthesiometer for Corneal Sensitivity (SLACS) and will be recorded in mbar.

  7±2 days and 5 weeks ±2

Secondary Outcomes (1)

• Correlation between corneal sensitivity threshold and subjective symptoms

  7±2 days and 5 weeks ±2

Study Arms (1)

Daily contact lens wear

OTHER

Participant wear silicone hydrogel contact lenses daily for 6 weeks ±2 days for a minimum wearing time of 5 days per week and 8 hours per day - corneal sensitivity will be measured and compared at baseline versus after 7±2 days and 5 weeks ±2 days daily contact lens wear.

Other: Device: silicone hydrogel contact lens

Interventions

Device: silicone hydrogel contact lens OTHER

Silicone hydrogel contact lens

Daily contact lens wear

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The Ocular Surface Disease Index questionnaire (OSDI) score for dry eye classification is ≤ 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 the start of the study.
• During the study, the participant wore the CL a minimum of 5 days per week for a minimum of 8 hours.
• The person being tested is in good health. This means that he or she does not suffer from any systemic diseases, such as diabetes or rheumatism, which could have an influence on eye health. He or she also has no eye disease and has not previously undergone corneal (refractive) surgery.

You may not qualify if:

• 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 corneal diameter 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 could influence ocular health, an ocular disease or has already undergone refractive surgery.
• Vulnerable participants

Sponsors & Collaborators

• Daniela Nosch: lead

Study Sites (1)

Optique Messerli Optometry centre

Marly, Canton of Fribourg, 1723, Switzerland

Location

Related Publications (6)

• 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: 15106930 BACKGROUND

• 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: 33775377 BACKGROUND

• 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: 12697417 BACKGROUND

• 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: 35156726 BACKGROUND

• Stapleton F, Marfurt C, Golebiowski B, Rosenblatt M, Bereiter D, Begley C, Dartt D, Gallar J, Belmonte C, Hamrah P, Willcox M; TFOS International Workshop on Contact Lens Discomfort. The TFOS International Workshop on Contact Lens Discomfort: report of the subcommittee on neurobiology. Invest Ophthalmol Vis Sci. 2013 Oct 18;54(11):TFOS71-97. doi: 10.1167/iovs.13-13226.

  PMID: 24058137 BACKGROUND

• Nichols JJ, Willcox MD, Bron AJ, Belmonte C, Ciolino JB, Craig JP, Dogru M, Foulks GN, Jones L, Nelson JD, Nichols KK, Purslow C, Schaumberg DA, Stapleton F, Sullivan DA; members of the TFOS International Workshop on Contact Lens Discomfort. The TFOS International Workshop on Contact Lens Discomfort: executive summary. Invest Ophthalmol Vis Sci. 2013 Oct 18;54(11):TFOS7-TFOS13. doi: 10.1167/iovs.13-13212. No abstract available.

  PMID: 24058135 BACKGROUND

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

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 27, 2023
• Study Start: April 8, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)