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Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05656885
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
1.5
Actual Duration (Months)
25.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study objective was to compare short-term clinical performance data of two soft spherical contact lenses.

Condition or Disease Intervention/Treatment Phase
  • Device: Soft Spherical Hydrogel Contact Lens A
  • Device: Soft Spherical Silicone Hydrogel Contact Lens B
 N/A

Detailed Description

The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of two soft spherical contact lenses after 15 minutes of daily wear each.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of Proclear Monthly and Avaira Vitality
Actual Study Start Date :
Sep 1, 2022
Actual Primary Completion Date :
Oct 18, 2022
Actual Study Completion Date :
Oct 18, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Soft Spherical Hydrogel Contact Lens A

Subjects will wear Soft Spherical Hydrogel Contact Lens A for the first period of 15 minutes and Soft Spherical Silicone Hydrogel Contact Lens B for the second period of 15 minutes.

Device: Soft Spherical Hydrogel Contact Lens A
Soft Spherical Hydrogel Contact Lens A - first period of 15 minutes
Experimental: Soft Spherical Silicone Hydrogel Contact Lens B

Subjects will wear Soft Spherical Silicone Hydrogel Contact Lens B for the second period of 15 minutes.

Device: Soft Spherical Silicone Hydrogel Contact Lens B
Soft Spherical Silicone Hydrogel Contact Lens B - second period of 15 minutes

Outcome Measures

Primary Outcome Measures

  1. Lens Fit Acceptance Ratings [15 minutes]

    Lens Fit Acceptance Ratings will be assessed based on lens fit alone on a scale of 0-4, where 0=Should not be worn, 4=Perfect

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 8 hours a day, 5 days a week.

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

  • Habitual soft contact lens wearers who currently wear sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.

  • Has refractive astigmatism no higher than -0.75DC.

  • Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00DS)

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 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 University Complutense of Madrid Madrid Spain 28037

Sponsors and Collaborators

  • Coopervision, Inc.

Investigators

  • Principal Investigator: Juan G Carracedo Rodríguez, OD,MSc,PhD, University Complutense of Madrid

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT05656885
Other Study ID Numbers:
  • EX-MKTG-142
First Posted:
Dec 19, 2022
Last Update Posted:
Dec 19, 2022
Last Verified:
Dec 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:
Hyperopia

Study Results

No Results Posted as of Dec 19, 2022