Dual Focus Soft Contact Lens Wear Cessation Study

NCT ID: NCT05779072

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-03-01

Brief Summary

The purpose of this study is to investigate the effect of ceasing treatment with dual focus soft contact lenses.

Detailed Description

This is a bilateral, open label, dispensing study with subjects who have completed dual focus soft contact lens wear treatment for either 3 or 6 years and who are refit to Proclear 1-day lens for 1 year.

Conditions

Myopia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dual Focus for 3 years

Group of subjects who completed dual focus soft contact lens wear treatment for 3 years

Group Type: OTHER

Single Vision Soft Contact Lens

Intervention Type: DEVICE

Subjects refit to Single Vision Soft Contact Lens for 1 year

Dual Focus for 6 years

Group of subjects who completed dual focus soft contact lens wear treatment for 6 years

Group Type: OTHER

Single Vision Soft Contact Lens

Intervention Type: DEVICE

Subjects refit to Single Vision Soft Contact Lens for 1 year

Interventions

Single Vision Soft Contact Lens

Subjects refit to Single Vision Soft Contact Lens for 1 year

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Successfully completed the MIST-401 Parts 1 and 2
• Visual acuity (VA) with CLs better than +0.25 log MAR (>6/12 or >20/40) in both eyes
• No ocular pathology or other contraindication to contact lens wear
• Where applicable (dependent on local requirements), have:

1. read the Informed Assent

2. been given an explanation of the Informed Assent,

3. indicated an understanding of the Informed Assent and

4. signed the Informed Assent Form. Or

5. read the Informed Consent,

6. been given an explanation of the Informed Consent,

7. indicated an understanding of the Informed Consent and

8. signed the Informed Consent Form.

• Where applicable (dependent on local requirements), have their parent or legal guardian:

1. read the Informed Consent,

2. been given an explanation of the Informed Consent,

3. indicated an understanding of the Informed Consent and

4. signed the Informed Consent Form.

• Along with their parent or guardian (if applicable), be capable of comprehending the nature of the study, and be willing and able to adhere to the instructions set forth in this protocol.
• Along with their parent or guardian (if applicable), agree to maintain the visit schedule and be able to keep all appointments as specified in the study protocol for the duration of the study.
• Agree to wear the assigned contact lenses for a minimum of 10 hours per day, at least 6 days per week, for the duration of the study and to inform the study investigator if this schedule is interrupted. (Wearing time may be modified by the study staff for health reasons.)
• Be in good general health, based on his/her and parent's/guardian's (if applicable) knowledge.
• Have best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye.

Exclusion Criteria

• Regular use of ocular medications (prescription or over-the-counter).
• Current use of systemic medications which, in the investigators opinion, may significantly affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
• Pregnant or lactating or planning a pregnancy at the time of enrolment.
• Known ocular or systemic disease such as, but not limited to: anterior uveitis or iritis, episcleritis or scleritis, glaucoma, Sjogren's syndrome, lupus erythematosus, scleroderma, or diabetes.
• Any ocular, systemic or neuro-developmental conditions that in the investigators opinion, could influence refractive development.
• Keratoconus or an irregular cornea.
• Biomicroscope findings that would contraindicate contact lens wear including, but not limited to:

1. Any active anterior segment ocular disease that would contraindicate contact lens wear.

2. clinically significant (Grade 3 or 4) abnormalities of the anterior segment, lids, conjunctiva, sclera or associated structures.

• The investigator for any reason considers that it is not in the best interest of the subject to participate in the study.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Visioncare Research Ltd.

OTHER

Sponsor Role: collaborator

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Graeme Young

Role: STUDY_DIRECTOR

Visioncare Research Ltd.

Locations

University of Waterloo School of Optometry

Waterloo, Ontario, Canada

University of Minho Clinical & Experiment Optometry Research Lab

Braga, , Portugal

National University of Singapore Faculty of Medicine

Singapore, , Singapore

Aston University Ophthalmic Research Group

Birmingham, , United Kingdom

Countries

Canada; Portugal; Singapore; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MIST-402

Identifier Type: -

Identifier Source: org_study_id