Myopia
Conditions
Keywords
Myopia Control
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.
Interventions
Subjects refit to Single Vision Soft Contact Lens for 1 year
Sponsors
Visioncare Research Ltd.
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 19 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada, Portugal, Singapore, United Kingdom
Participant flow
Pre-assignment details
Eighty-three participants were enrolled, and 76 participants completed the study. The primary reason was due to decreased vision related to astigmatism.
Participants by arm
| Arm | Count |
|---|---|
| Dual Focus for 3 Years Group of subjects who completed dual focus soft contact lens wear treatment for 3 years | 40 |
| Dual Focus for 6 Years Group of subjects who completed dual focus soft contact lens wear treatment for 6 years | 43 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 5 |
Baseline characteristics
| Characteristic | Dual Focus for 3 Years | Dual Focus for 6 Years | Total |
|---|---|---|---|
| Age, Continuous | 16.1 years STANDARD_DEVIATION 1.58 | 16.3 years STANDARD_DEVIATION 1.2 | 16.2 years STANDARD_DEVIATION 1.39 |
| Race/Ethnicity, Customized Black British | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian (European) | 27 Participants | 28 Participants | 55 Participants |
| Race/Ethnicity, Customized East Asian | 10 Participants | 13 Participants | 23 Participants |
| Race/Ethnicity, Customized Hispanic - Latino | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Indian/Pakistani/SriLankan | 5 Participants | 3 Participants | 8 Participants |
| Race/Ethnicity, Customized Mediterranean | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Middle Eastern | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 20 Participants | 22 Participants | 42 Participants |
| Sex: Female, Male Male | 20 Participants | 21 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 43 |
| other Total, other adverse events | 2 / 40 | 3 / 43 |
| serious Total, serious adverse events | 0 / 40 | 0 / 43 |
Outcome results
Primary
Change in Axial Length (AL)
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.
Time frame: 1 year
Population: \[Not Specified\]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dual Focus for 3 Years | Change in Axial Length (AL) | 0.09 mm | Standard Deviation 0.09 |
| Dual Focus for 6 Years | Change in Axial Length (AL) | 0.10 mm | Standard Deviation 0.103 |
Primary
Change in Spherical Equivalent Refractive Error (SERE)
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.
Time frame: 1 year
Population: \[Not specified\]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dual Focus for 3 Years | Change in Spherical Equivalent Refractive Error (SERE) | -0.23 D | Standard Deviation 0.363 |
| Dual Focus for 6 Years | Change in Spherical Equivalent Refractive Error (SERE) | -0.21 D | Standard Deviation 0.397 |