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Evaluation of The Performance of Monthly Replacement Sphere Lens Deigns in Habitual Soft Contact Lens Wearers

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05114564
Collaborator
(none)
60
Enrollment
4
Locations
2
Arms
5.8
Actual Duration (Months)
15
Patients Per Site
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of the study is to evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for 1-month.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Evaluation of The Performance of Monthly Replacement Sphere Lens Deigns in Habitual Soft Contact Lens Wearers
Actual Study Start Date :
Nov 1, 2021
Actual Primary Completion Date :
Apr 27, 2022
Actual Study Completion Date :
Apr 27, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lens A (Test)

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

Device: Lens A (Test)
Test Lens A

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

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

Device: Lens A (Test)
Test Lens A

Device: Control Lens B
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 (0-10 scale, 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:

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

  • Has read and signed an information consent letter;

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

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

  • 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, smart- phone;

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

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

  • Habitually wears soft frequent replacement contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens brand is restricted such that no more than one third are to be the Biofinity brand (or their equivalent private label brand name) and no more than one third are to be an Alcon brand;

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

  • 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:

  • Is participating in any concurrent clinical or research study;

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

  • Has a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable;

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

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

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

  • Has undergone refractive error surgery or intraocular surgery.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Complete Eye Care of Medina Minnesota Minnesota United States 55364
2 Sacco Eye Group PLLC, Vestal New York United States 13850
3 Athens Eye Care Athens Ohio United States 45701
4 ProCare Vision Center Granville Ohio United States 43023

Sponsors and Collaborators

  • Coopervision, Inc.

Investigators

  • Principal Investigator: Shane Foster, Athens Eye Care,
  • Principal Investigator: Andrew Sacco, Sacco Eye Group PLLC
  • Principal Investigator: Gina Wesley, Complete Eye Care of Medina
  • Principal Investigator: Katherine Bickle, ProCare Vision Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT05114564
Other Study ID Numbers:
  • EX-MKTG-129
First Posted:
Nov 10, 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:
Myopia

Study Results

No Results Posted as of May 24, 2022