Influence of Silicone Hydrogel Contact Lens Neophyte Wear on Corneal Sensitivity

Cornea Clinical Trial

— CSCL  

Official title:

Corneal Sensitivity in Silicone Hydrogel Contact Lens Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05745220
• Other study ID #: 2022-D0124
• Status: Completed
• Phase: N/A
• Start date: April 8, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2024
• Source: University of Applied Sciences and Arts Northwestern Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 38 Years

Eligibility

Inclusion Criteria:

• 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.

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 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

Related Conditions & MeSH terms

• Cornea
• Hypersensitivity

Intervention

Other:
• Device: silicone hydrogel contact lens
Silicone hydrogel contact lens

Locations

Country	Name	City	State
Switzerland	Optique Messerli Optometry centre	Marly	Fribourg

Sponsors (1)

Lead Sponsor	Collaborator
Daniela Nosch

Country where clinical trial is conducted

Switzerland, 

References & 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. — View 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. — View 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. — View Citation

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation between corneal sensitivity threshold and subjective symptoms	Correlation between corneal sensitivity threshold and subjective symptoms after one and six weeks of daily contact lens wear: corneal sensitivity threshold will be determined with the Swiss Liquid Jet Aesthesiometer for Corneal Sensitivity (SLACS) and will be recorded in mbar. Subjective Symptoms will be recorded with the Contact Lens Dry Eye Questionnaire (CLDEQ-8) scored from 0=comfortable to 37=uncomfortable (specifically designed to assess contact lens comfort)	7±2 days and 5 weeks ±2