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Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses

Primary Purpose

Myopia, Hyperopia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Soft Spherical Hydrogel Contact Lens A
Soft Spherical Silicone Hydrogel Contact Lens B
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University Complutense of Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Soft Spherical Hydrogel Contact Lens A

Soft Spherical Silicone Hydrogel Contact Lens B

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Lens Fit Acceptance Ratings
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

Secondary Outcome Measures

Full Information

First Posted
December 2, 2022
Last Updated
December 16, 2022
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05656885
Brief Title
Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses
Official Title
Clinical Evaluation of Proclear Monthly and Avaira Vitality
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
October 18, 2022 (Actual)
Study Completion Date
October 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Soft Spherical Hydrogel Contact Lens A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Soft Spherical Silicone Hydrogel Contact Lens B
Arm Type
Experimental
Arm Description
Subjects will wear Soft Spherical Silicone Hydrogel Contact Lens B for the second period of 15 minutes.
Intervention Type
Device
Intervention Name(s)
Soft Spherical Hydrogel Contact Lens A
Intervention Description
Soft Spherical Hydrogel Contact Lens A - first period of 15 minutes
Intervention Type
Device
Intervention Name(s)
Soft Spherical Silicone Hydrogel Contact Lens B
Intervention Description
Soft Spherical Silicone Hydrogel Contact Lens B - second period of 15 minutes
Primary Outcome Measure Information:
Title
Lens Fit Acceptance Ratings
Description
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
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan G Carracedo Rodríguez, OD,MSc,PhD
Organizational Affiliation
University Complutense of Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Complutense of Madrid
City
Madrid
ZIP/Postal Code
28037
Country
Spain

12. IPD Sharing Statement

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Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses

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