Evaluation of The Clinical Acceptance of Soft Contact Lenses for Myopia Control

August 3, 2024 updated by: CooperVision, Inc.
The main objective of the study was to evaluate the clinical acceptance of soft contact lenses for Myopia control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants were randomized to wear each study contact lenses for 10 days with investigator and participant masking. The participants who are not contact lens wearer at enrollment wore single vision contact lenses for two weeks during the pre-investigation phase to get adapted to contact lens wear.

Study Type

Interventional

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW1E 6AU
        • Ocular Technology Group - International

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 10 to 16 years;
  • Spectacle refraction: -0.75 to -6.00D spherical equivalent, maximum anisometropia 1.25D, cylinder up to -1.00DC
  • Best corrected visual acuity of at least 20/25 in each eye.
  • Parents/guardians and participant have read and understood the Participant Information Sheet;
  • Parents/guardians and participant have read, signed and dated the Informed Consent;
  • Have normal eyes with the exception of the need for visual correction;
  • Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule.

Exclusion Criteria:

  • Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
  • Newly prescribed use of some systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
  • Monocular participants (only one eye with functional vision) or participants fit with only one lens;
  • Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit;
  • History of herpetic keratitis, ocular surgery or irregular cornea;
  • Enrolment of the family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omafilcon A Control Lens first, then Omafilcon A Test Lens 1, then Omafilcon A Test Lens 2
Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.
Device: omafilcon A control lens
Participants were randomized to wear omafilcon A control soft contact lens for 10 days.
Device: omafilcon A test lens 1
Participants were randomized to wear omafilcon A test soft contact lens 1 for 10 days.
Device: omafilcon A test lens 2
Participants were randomized to wear omafilcon A test soft contact lens 2 for 10 days.
Experimental: Omafilcon A Test Lens 2 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 1
Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.
Device: omafilcon A control lens
Participants were randomized to wear omafilcon A control soft contact lens for 10 days.
Device: omafilcon A test lens 1
Participants were randomized to wear omafilcon A test soft contact lens 1 for 10 days.
Device: omafilcon A test lens 2
Participants were randomized to wear omafilcon A test soft contact lens 2 for 10 days.
Experimental: Omafilcon A Test Lens 1 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 2
Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.
Device: omafilcon A control lens
Participants were randomized to wear omafilcon A control soft contact lens for 10 days.
Device: omafilcon A test lens 1
Participants were randomized to wear omafilcon A test soft contact lens 1 for 10 days.
Device: omafilcon A test lens 2
Participants were randomized to wear omafilcon A test soft contact lens 2 for 10 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Vision Satisfaction
Time Frame: 10 days
Overall vision satisfaction recorded on a visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy)
10 days
Habitual Daily Wearing Time
Time Frame: 10 days
Habitual daily wearing time in hours
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: 10 days
Visual acuity measured using logMAR
10 days
Overall Visual Satisfaction During the Use of iPad With White Screen
Time Frame: 10 days
Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy)
10 days
Visual Satisfaction During the Use of Ipad With White Screen- How Clear is the Close-up Vision.
Time Frame: 10 Days
Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Clear at All, 100 - Very Clear)
10 Days
Visual Satisfaction During the Use of iPad With Black Screen- How Happy the Vision is.
Time Frame: 10 Days
Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy)
10 Days
Visual Satisfaction During the Use of Ipad With Black Screen- How Clear is the Close-up the Vision is.
Time Frame: 10 Days
Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Clear at All, 100 - Very Clear)
10 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CooperVision, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2019

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 3, 2024

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV-20-51

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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