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CorneaCSCLNCT05745220

Influence of Silicone Hydrogel Contact Lens Neophyte Wear on Corneal Sensitivity

A study testing Device: silicone hydrogel contact lens in people with Cornea, run by Daniela Nosch at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 38 yearsHealthy volunteers can take part
Conditions the study is for
Cornea
What is being tested?
Device: silicone hydrogel contact lens
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteSwitzerland
Study dates
8 Apr 2023to 30 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 38 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Optique Messerli Optometry centre

    Marly, Canton of Fribourg, 1723

Other trials in Switzerland

About this study

Official title: Corneal Sensitivity in Silicone Hydrogel Contact Lens Wear

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.

Read the detailed 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.

Conditions
Cornea
Being tested
Device: silicone hydrogel contact lens
Keywords
silicone hydrogel contact lens, daily contact lens wear, corneal sensitivity, esthesiometry
Medical subject headings
Corneal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Device: silicone hydrogel contact lensOther

    Silicone hydrogel contact lens

Study groups in NCT05745220
Study groupRoleWhat they receive
Daily contact lens wearOtherParticipant 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.
Receives: Other: Device: silicone hydrogel contact lens

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 7±2 days and 5 weeks ±2

Secondary outcomes (1)

  1. 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)

    Measured: 7±2 days and 5 weeks ±2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2023
  2. Study start8 Apr 2023
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05745220
Sponsor's protocol ID
2022-D0124
Acronym
CSCL
Status last verified
Feb 2024
First submitted
16 Feb 2023
Last updated
26 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 15106930

  • 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.

    PubMed 33775377

  • 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.

    PubMed 12697417

  • 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.

    PubMed 35156726

  • 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.

    PubMed 24058137

  • 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.

    PubMed 24058135

Questions about this trial

What is this clinical trial studying?

A study testing Device: silicone hydrogel contact lens in people with Cornea, run by Daniela Nosch at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in corneal sensitivity threshold baseline and after one and six weeks of daily contact lens wear (time frame: 7±2 days and 5 weeks ±2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05745220, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.

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