Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04831515
Collaborator
(none)
52
Enrollment
4
Locations
2
Arms
3.1
Actual Duration (Months)
13
Patients Per Site
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Lens A
  • Device: Lens B
N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers
Actual Study Start Date :
Mar 29, 2021
Actual Primary Completion Date :
Jul 2, 2021
Actual Study Completion Date :
Jul 2, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Lens A

daily disposable soft contact lens - test lens Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week.

Device: Lens A
daily disposable soft contact lens - test lens

Device: Lens B
daily disposable soft contact lens - control lens

Active Comparator: Lens B

daily disposable soft contact lens - control lens Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week.

Device: Lens A
daily disposable soft contact lens - test lens

Device: Lens B
daily disposable soft contact lens - control lens

Outcome Measures

Primary Outcome Measures

  1. Overall Ease of Lens Handling [1 week]

    Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy)

Secondary Outcome Measures

  1. Visual Acuity [1 week]

    Visual acuity will be measured using LogMAR scale in high room illumination: distance (≥4m)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Is at least 18 years of age and has full legal capacity to volunteer;

  • Has read and signed an information consent letter;

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

  • Anticipates being able to wear the study lenses for at least 12 hours a day, 7 days a week;

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

  • Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum;

  • Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC;

  • Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees;

  • Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively;

  • Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters

Exclusion Criteria:
  • Is participating in any concurrent clinical or research study;

  • Habitually wears one of the study contact lenses;

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

  • Has a systemic 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

SiteCityStateCountryPostal Code
1Golden Optometric GroupWhittierCaliforniaUnited States90606
2Golden VisionSarasotaFloridaUnited States34237
3Sacco Eye GroupVestalNew YorkUnited States13850
4Athens Eye CareAthensOhioUnited States45701

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:
NCT04831515
Other Study ID Numbers:
  • EX-MKTG-122
First Posted:
Apr 5, 2021
Last Update Posted:
Aug 19, 2021
Last Verified:
Aug 1, 2021
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:

Study Results

No Results Posted as of Aug 19, 2021