Dual Focus Soft Contact Lens Wear Cessation Study

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Single Vision Soft Contact Lens

• Registration Number: NCT05779072
• Lead Sponsor: Coopervision, Inc.

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.

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-22
• Results First Submitted: 2023-09-13
• Results First Submitted QC: 2023-10-09
• Last Update Submitted: 2023-10-09
• Results First Posted: 2023-11-01
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual Focus for 3 years	Single Vision Soft Contact Lens	Group of subjects who completed dual focus soft contact lens wear treatment for 3 years
Dual Focus for 6 years	Single Vision Soft Contact Lens	Group of subjects who completed dual focus soft contact lens wear treatment for 6 years

Primary Outcome Measures

Name	Time	Method
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). Cycloplegic autorefraction was used to measure refractive error.
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). Partial coherence interferometry was used to measure axial length.

Trial Locations

Locations (4)

National University of Singapore Faculty of Medicine; 🇸🇬 Singapore, Singapore

University of Waterloo School of Optometry; 🇨🇦 Waterloo, Ontario, Canada

Aston University Ophthalmic Research Group; 🇬🇧 Birmingham, United Kingdom

University of Minho Clinical & Experiment Optometry Research Lab; 🇵🇹 Braga, Portugal