Clinical trial NCT05779072: Dual Focus Soft Contact Lens Wear Cessation Study
Official title: MiSight Lens Wear Cessation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Myopia Control
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
Collaborators: name: Visioncare Research Ltd.
First posted: 2023-03-22
Enrollment: 83
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change in Spherical Equivalent Refractive Error (SERE)
timeFrame: 1 year
measure: Change in Axial Length (AL)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo School of Optometry
state: Ontario
city: Braga
country: Portugal
facility: University of Minho Clinical & Experiment Optometry Research Lab
city: Singapore
country: Singapore
facility: National University of Singapore Faculty of Medicine
city: Birmingham
country: United Kingdom
facility: Aston University Ophthalmic Research Group
Study officials:
affiliation: Visioncare Research Ltd.
name: Graeme Young
role: STUDY_DIRECTOR
References: