Back to resultsInfluence of Silicone Hydrogel Contact Lens Neophyte Wear on Corneal Sensitivity (CSCL)
Primary Purpose
Cornea
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Device: silicone hydrogel contact lens
Sponsored by
About this trial
This is an interventional other trial for Cornea focused on measuring silicone hydrogel contact lens, daily contact lens wear, corneal sensitivity, esthesiometry
Eligibility Criteria
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
Sites / Locations
- Optique Messerli Optometry centreRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Daily contact lens wear
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05745220
Brief Title
Influence of Silicone Hydrogel Contact Lens Neophyte Wear on Corneal Sensitivity
Acronym
CSCL
Official Title
Corneal Sensitivity in Silicone Hydrogel Contact Lens Wear
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniela Nosch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cornea
Keywords
silicone hydrogel contact lens, daily contact lens wear, corneal sensitivity, esthesiometry
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Daily contact lens wear
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Device: silicone hydrogel contact lens
Intervention Description
Silicone hydrogel contact lens
Primary Outcome Measure Information:
Title
Difference in corneal sensitivity threshold baseline and after one and six weeks of daily contact lens wear
Description
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.
Time Frame
7±2 days and 5 weeks ±2
Secondary Outcome Measure Information:
Title
Correlation between corneal sensitivity threshold and subjective symptoms
Description
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)
Time Frame
7±2 days and 5 weeks ±2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Nosch, PhD
Phone
+41789120520
Email
daniela.nosch@fhnw.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Nosch, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Nosch, PhD
Organizational Affiliation
Institute of Optometry, FHNW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optique Messerli Optometry centre
City
Marly
State/Province
Fribourg
ZIP/Postal Code
1723
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion Seghetti, BSc
Phone
0041 77 408 30 88
Email
seghettiml@cardiff.ac.uk
First Name & Middle Initial & Last Name & Degree
Marion Seghetti, BSc
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15106930
Citation
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.
Results Reference
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PubMed Identifier
33775377
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.
Results Reference
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PubMed Identifier
12697417
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.
Results Reference
background
PubMed Identifier
35156726
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.
Results Reference
background
PubMed Identifier
24058137
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.
Results Reference
background
PubMed Identifier
24058135
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.
Results Reference
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Influence of Silicone Hydrogel Contact Lens Neophyte Wear on Corneal Sensitivity
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