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

NCT ID: NCT04709237

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-14
• Study Completion Date: 2021-03-31

Brief Summary

The main objective of the study was to evaluate the clinical acceptance of soft contact lenses for Myopia control.

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

omafilcon A control lens

Intervention Type: DEVICE

Participants were randomized to wear omafilcon A control soft contact lens for 10 days.

omafilcon A test lens 1

Intervention Type: DEVICE

Participants were randomized to wear omafilcon A test soft contact lens 1 for 10 days.

omafilcon A test lens 2

Intervention Type: DEVICE

Participants were randomized to wear omafilcon A test soft contact lens 2 for 10 days.

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.

Group Type: EXPERIMENTAL

omafilcon A control lens

Intervention Type: DEVICE

Participants were randomized to wear omafilcon A control soft contact lens for 10 days.

omafilcon A test lens 1

Intervention Type: DEVICE

Participants were randomized to wear omafilcon A test soft contact lens 1 for 10 days.

omafilcon A test lens 2

Intervention Type: DEVICE

Participants were randomized to wear omafilcon A test soft contact lens 2 for 10 days.

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.

Group Type: EXPERIMENTAL

omafilcon A control lens

Intervention Type: DEVICE

Participants were randomized to wear omafilcon A control soft contact lens for 10 days.

omafilcon A test lens 1

Intervention Type: DEVICE

Participants were randomized to wear omafilcon A test soft contact lens 1 for 10 days.

omafilcon A test lens 2

Intervention Type: DEVICE

Participants were randomized to wear omafilcon A test soft contact lens 2 for 10 days.

Interventions

omafilcon A control lens

Participants were randomized to wear omafilcon A control soft contact lens for 10 days.

Intervention Type: DEVICE

omafilcon A test lens 1

Participants were randomized to wear omafilcon A test soft contact lens 1 for 10 days.

Intervention Type: DEVICE

omafilcon A test lens 2

Participants were randomized to wear omafilcon A test soft contact lens 2 for 10 days.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ocular Technology Group - International

London, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CV-20-51

Identifier Type: -

Identifier Source: org_study_id