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Evaluation of Monthly Replacement Lens Designs in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05166902
Collaborator
(none)
66
Enrollment
4
Locations
2
Arms
6.2
Anticipated Duration (Months)
16.5
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses who report use of digital devices at least 6 hours per day. Each study lens type will be worn for 1-month.

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

Detailed Description

This study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over, daily-wear design involving two different FRP lens types. Each lens type will be worn for approximately one month, during which participants record their subjective lens-wear experience.

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Evaluation of Monthly Replacement Lens Designs in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use
Actual Study Start Date :
Jan 24, 2022
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lens A (Test)

Subjects will be randomized to wear test lens A for one month and then cross over to wear control lens B for one month.

Device: Lens A (Test)
Test lens A

Device: Lens B (Control)
Control lens B
Active Comparator: Lens B (Control)

Subjects will be randomized to wear control lens B for one month and then cross over to wear test lens A for one month.

Device: Lens A (Test)
Test lens A

Device: Lens B (Control)
Control lens B

Outcome Measures

Primary Outcome Measures

  1. Subjective Ratings on Lens Handling on Removal [Day 27]

    Subjective ratings on lens handling on removal will be measured on a scale of 0-10, 0.5 steps (0- Very Easy, 10- Very Difficult)

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 at least 18 years of age and no older than 35 years, and has full legal capacity to volunteer;

  2. Has read and signed an information consent letter;

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

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

  5. Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;

  6. Has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;

  7. Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;

  8. Habitually wears soft frequent replacement contact lenses, for the past 3 months minimum;

  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 +6.00 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 or ocular 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 Coan Eye Care Ocoee Florida United States 34761
2 Nittany Eye Associate State College Pennsylvania United States 168801
3 Eyes on Sheppard Clinic Toronto Ontario Canada M2N 3A4
4 Spadina Optometry Toronto Ontario Canada M5V3E7

Sponsors and Collaborators

  • Coopervision, Inc.

Investigators

  • Study Director: Lyndon Jones, Centre for Ocular Research & Education

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT05166902
Other Study ID Numbers:
  • EX-MKTG-130
First Posted:
Dec 22, 2021
Last Update Posted:
May 24, 2022
Last Verified:
May 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:
Refractive Errors

Study Results

No Results Posted as of May 24, 2022