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Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses.

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05805059
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
5.1
Anticipated Duration (Months)
11.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to compare the performance of two daily disposable silicone hydrogel contact lenses.

Condition or Disease Intervention/Treatment Phase
  • Device: Control Contact Lens (stenfilcon A)
  • Device: Test Contact Lens (senofilcon A)
 N/A

Detailed Description

This study is a prospective, bilateral eye, double masked, randomized, 1-week crossover, daily wear design involving two different daily disposable lens types. Each lens type will be worn for approximately one week.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses.
Anticipated Study Start Date :
Apr 7, 2023
Anticipated Primary Completion Date :
Sep 8, 2023
Anticipated Study Completion Date :
Sep 8, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Control Contact Lens, Then Test Contact Lens

Participants will wear control contact lenses for one week and then crossover to test contact lenses for one week.

Device: Control Contact Lens (stenfilcon A)
one week wear

Device: Test Contact Lens (senofilcon A)
one week of wear
Experimental: Test Contact Lens, Then Control Contact Lens

Participants will wear test contact lenses for one week and then crossover to control contact lenses for one week.

Device: Control Contact Lens (stenfilcon A)
one week wear

Device: Test Contact Lens (senofilcon A)
one week of wear

Outcome Measures

Primary Outcome Measures

  1. Lens Handling on Removal [6 days of wear]

    Lens Handling on Removal, using a 0-100 scale (0=Very difficult, 100=Very easy)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;

  2. Has read and signed an information consent letter;

  3. Self-reports having a full eye examination in the previous two years;

  4. Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;

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

  6. Habitually wears soft contact lenses, for the past 3 months minimum;

  7. No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys

  8. No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day.

  9. Has refractive astigmatism no higher than -0.75DC in each eye;

  10. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).

Exclusion Criteria:

  1. Is participating in any concurrent clinical or research study;

  2. Has any known active ocular disease and/or infection that contraindicates contact lens wear;

  3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

  4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;

  5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;

  6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;

  7. Has undergone refractive error surgery or intraocular surgery.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Complete Eye Care of Medina/Complete Vision Solutions Medina Minnesota United States 55340

Sponsors and Collaborators

  • Coopervision, Inc.

Investigators

  • Study Director: Lyndon Jones, PhD,FCOptom, Centre for Ocular Research and Education

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT05805059
Other Study ID Numbers:
  • EX-MKTG-145
First Posted:
Apr 7, 2023
Last Update Posted:
Apr 7, 2023
Last Verified:
Mar 1, 2023
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 Apr 7, 2023