Dual Focus Soft Contact Lens Wear Cessation Study

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05779072
• Collaborator: Visioncare Research Ltd. (Other)
• Enrollment: 83
• Locations: 4
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site: 20.8
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Single Vision Soft Contact Lens	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: MiSight Lens Wear Cessation Study
• Actual Study Start Date: Mar 1, 2019
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Dual Focus for 3 years Group of subjects who completed dual focus soft contact lens wear treatment for 3 years	Device: Single Vision Soft Contact Lens; Subjects refit to Single Vision Soft Contact Lens for 1 year
Other: Dual Focus for 6 years Group of subjects who completed dual focus soft contact lens wear treatment for 6 years	Device: Single Vision Soft Contact Lens; Subjects refit to Single Vision Soft Contact Lens for 1 year

Outcome Measures

Primary Outcome Measures

1. Change in spherical equivalent refractive error (SERE) [1 year]

   Change in spherical equivalent refractive error (SERE) relative to baseline (i.e., at end of dual focus soft contact lens wear treatment of either 3 or 6 years)

2. Change in axial length (AL) [1 year]

   Change in axial length (AL) relative to baseline (i.e., at end of dual focus soft contact lens wear treatment of either 3 or 6 years)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 19 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Waterloo School of Optometry	Waterloo	Ontario	Canada	N2L 3G1
2	University of Minho Clinical & Experiment Optometry Research Lab	Braga		Portugal	4710-057
3	National University of Singapore Faculty of Medicine	Singapore		Singapore	117597
4	Aston University Ophthalmic Research Group	Birmingham		United Kingdom	B4 7ET

Sponsors and Collaborators

• Coopervision, Inc.
• Visioncare Research Ltd.

Investigators

• Study Director: Graeme Young, Visioncare Research Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT05779072
• Other Study ID Numbers: MIST-402
• First Posted: Mar 22, 2023
• Last Update Posted: Mar 22, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Coopervision, Inc.: Myopia Control
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Mar 22, 2023