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Comparing Silicone Hydrogel Contact Lens Wearers to Hydrogel Contact Lens Wearers and Non-lens Wearers

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04886479
Collaborator
(none)
78
Enrollment
1
Location
3
Arms
17
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objectives of this study is to to compare baseline data between 3 groups - habitual wearers of DDSH (Daily Disposable Silicone Hydrogel) contact lenses / habitual wearers of DDH (Daily Disposable Hydrogel) contact lenses / non-lens wearers for physiological responses and to compare the physiological responses post closed eye lens wear in 2 groups - habitual wearers of DDSH /habitual wearers of DDH after 3 hours.

Condition or Disease Intervention/Treatment Phase
  • Device: Daily Disposable Silicone Hydrogel Contact Lens
  • Device: Daily Disposable Hydrogel Contact Lens
  • Other: Non Lens Wearers
 N/A

Detailed Description

This study is a multi-site, prospective, randomized, non-masked, unilateral, non-dispensing study.

Study Design

Study Type:
Interventional
Actual Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparing Habitual Daily Disposable Silicone Hydrogel Contact Lens Wearers to Habitual Daily Disposable Hydrogel Contact Lens Wearers and Non-lens Wearers
Actual Study Start Date :
May 30, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Daily Disposable Silicone Hydrogel Contact Lens

Subjects will be randomized to wear Daily Disposable Silicone Hydrogel Contact Lens in one eye and will be patched for 3 hours with the contralateral eye remain open.

Device: Daily Disposable Silicone Hydrogel Contact Lens
Subjects will be randomized to wear Daily Disposable Silicone Hydrogel Contact Lens in one eye and will be patched for 3 hours with the contralateral eye remain open.
Active Comparator: Habitual Daily Disposable Hydrogel Contact Lens

Subjects will be randomized to wear Daily Disposable Hydrogel Contact Lens in one eye and will be patched for 3 hours with the contralateral eye remain open.

Device: Daily Disposable Hydrogel Contact Lens
Subjects will be randomized to wear Daily Disposable Hydrogel Contact Lens in one eye and will be patched for 3 hours with the contralateral eye remain open.
Active Comparator: Non-lens wearers

Subjects with no previous history of contact lens wear

Other: Non Lens Wearers
Subjects with no previous history of contact lens wear

Outcome Measures

Primary Outcome Measures

  1. Limbal Redness [3 hours]

    Limbal redness will be measured on EFRON Scale of 0-4, 0.1 steps (0-none, 1- Trace, 2-Mild, 3-Moderate, 4- Severe)

  2. Bulbar Redness [3 hours]

    Bulbar redness will be measured on EFRON Scale of 0-4, 0.1 steps (0-none, 1- Trace, 2-Mild, 3-Moderate, 4- Severe)

  3. Corneal vessel ingrowth [3 hours]

    Corneal vessel ingrowth will be measured using slit lamp photography and image analysis for longest vessel in mm (0.1 to 5mm in 0.01 steps, 0.1mm - Short Vessel, 5mm - Long vessel)

  4. Number of Corneal vessel ingrowth [3 hours]

    Number of Corneal vessel ingrowth greater than 0.5mm will be measured using slit lamp photography and image analysis on a scale of 0-99 (0- best, 99- worst case)

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Is between 17 and 60 years of age inclusive (age matching required between all 3 study groups), and has full legal capacity to volunteer;

  2. Has had a self-reported oculo-visual examination in the last two years.

  3. Has read and signed an information consent letter;

  4. Is willing and able to follow instructions and maintain the appointment schedule;

  5. No previous history of overnight contact lens wear or PMMA (polymethylmethacrylate) lens wear.

  6. Auto-refraction vertexed spherical equivalent between +4.00 and -8.00 (prescription matching required between groups 1 & 2). This criterion is non-applicable to participants in group 3.

  7. Is found to be in one of the study groups matched by age (±5 years), ethnicity (Asian vs. non-Asian) and CL Rx (±2.00 D) according using the following criteria.

GROUP 1: For the past (minimum) 6 months has ONLY worn spherical DDSH lenses AND prior to wearing this lens they only wore SH material lenses in the past (minimum) 3 total years.

GROUP 2: For the past (minimum) 6 months has ONLY worn spherical DDH lenses AND prior to wearing this lens they only wore H material lenses in the past (minimum) 3 total years.

  1. For groups 1 & 2, currently and for at least the previous 6 months has had habitual daily disposable wear schedule of at least 8 hrs a day, 5 days a week in only one material category - either silicone hydrogel or hydrogel material. This criterion is not-applicable to participants in group 3.

  2. Is willing to wear the study contact lens in the randomized eye for 3 hours of eye closure on the second study day. This criterion is not-applicable to participants in group 3.

  3. Has clear and healthy corneas and anterior eye and no active* ocular disease;

  4. Can achieve monocular HCVA of logMAR 0.10 or better in each eye with subjective refraction or pinhole.

  5. Can achieve acceptable fit and comfort in the randomized eye with the study lens. This criterion will be confirmed at the baseline visit (V1). This criterion is not-applicable to participants in group 3.

  6. Has a wearable pair of spectacles.

Exclusion Criteria:

  1. Is participating in any concurrent clinical trial;

  2. Is unable/unwilling to provide permission for the study site to seek CL history from their eye care practitioner

  3. Has any known active* ocular disease and/or infection;

  4. Has a systemic condition that in the opinion of the investigator may affect a study measure or interfere with contact lens wear; this may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes, and systemic connective tissue disorders e.g. rheumatoid arthritis.

  5. Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;

  6. Has known sensitivity to fluorescein dye, topical anesthetic, or products to be used in the study;

  7. Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;

  8. Appears to have any signs of corneal inflammation or previous infection or corneal opacity/scar;

  9. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit), due to potential ocular physiological changes, such as changes in the corneal shape and cell types;

  10. Is aphakic;

  11. Has undergone refractive error surgery, or has a history of any ocular surgery or injury.

  12. Is a toric or multifocal contact lens wearer.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eurolens Research Manchester United Kingdom

Sponsors and Collaborators

  • Coopervision, Inc.

Investigators

  • Principal Investigator: Lyndon Jones, PhD FCOptom, Centre for Ocular Research & Education

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT04886479
Other Study ID Numbers:
  • EX-MKTG-89
First Posted:
May 14, 2021
Last Update Posted:
Mar 8, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Myopia

Study Results

No Results Posted as of Mar 8, 2022