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To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05333965
Collaborator
(none)
25
Enrollment
1
Location
2
Arms
5.1
Anticipated Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual FRP CL wearers when worn for 1-month.

Condition or Disease Intervention/Treatment Phase
  • Device: Lens A
  • Device: Lens B
 N/A

Detailed Description

This study will be a prospective, randomized, double-masked, single-site, 1-month cross-over design involving bilateral eye daily wear of two different monthly replacement CL types. Each lens will be worn bilaterally for approximately one month.

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear
Actual Study Start Date :
Apr 27, 2022
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lens A - Test Silicone Hydrogel Lens

Lens A - Monthly Replacement Test Silicone Hydrogel Lens

Device: Lens A
Subjects will be randomized to wear test lens A for one month.

Device: Lens B
Subjects will be randomized to wear control lens B for one month.
Active Comparator: Lens B- Control Silicone Hydrogel Lens

Lens B - Monthly Replacement Control Silicone Hydrogel Lens

Device: Lens A
Subjects will be randomized to wear test lens A for one month.

Device: Lens B
Subjects will be randomized to wear control lens B for one month.

Outcome Measures

Primary Outcome Measures

  1. Lens handling subjective response for lens removal [1 month]

    Lens handling subjective response for lens removal will be measured on a scale of 0-10, 0.5 steps (0=Completely dissatisfied,10=Completely satisfied)

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Is at least 17 years of age and has full legal capacity to volunteer;

  2. Self-reports having had a full eye examination within the previous 2 years;

  3. Has read and signed an information consent letter;

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

  5. Is a habitual wearer of frequent replacement contact lenses;

  6. Anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day during the study;

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

  8. Can be successfully fit with both study lens types;

  9. Achieves at least 0.4 logMAR VA monocularly and at least 0.2 logMAR VA binocularly with each study lens type.

Exclusion Criteria:

  1. Is participating in any concurrent clinical research study;

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

  3. Has an unstable systemic condition that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;

  4. Is using any systemic or topical medications in an irregular routine that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;

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

  6. Is an employee of the Centre for Ocular Research & Education.

Contacts and Locations

Locations

Site City State Country Postal Code
1 School of Optometry & Vision Science Waterloo Canada N2L 3G1

Sponsors and Collaborators

  • Coopervision, Inc.

Investigators

  • Principal Investigator: 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:
NCT05333965
Other Study ID Numbers:
  • EX-MKTG-132
First Posted:
Apr 19, 2022
Last Update Posted:
Apr 29, 2022
Last Verified:
Apr 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 Apr 29, 2022