An Evaluation of the Effectiveness of Dual Focus Soft Contact Lenses in Slowing Mypoia Progression

Myopia Clinical Trial

Official title:

A Multicentre Dispensing Clinical Evaluation of MiSight® Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729208
• Other study ID #: CVI08008
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: May 2019

Study information

• Verified date: February 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.

Description:

Subjects were randomized to wear test or control soft contact lens to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: May 2019
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Be between 8 and 12 years of age inclusive.

• Best-corrected visual acuity by manifest refraction of +0.10 logMAR.

• Spherical Equivalent Refractive Error between -0.75 and -4.00 D

• inclusive astigmatism: < -0.75 D and anisometropia: < 1.00 D

• Possess wearable and visually functional eyeglasses.

• 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 3 year study.

Exclusion Criteria:

• Subject has previously or currently wears contact lenses or rigid gas permeable contact lenses, including orthokeratology lenses.

• Subject is currently or within 30 days prior to this study has been an active participant in another clinical study.

• Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine or ANY other myopia control treatment.

• Regular use of ocular medications (prescription or over-the-counter), artificial tears, or wetting agents.

• Current use of systemic medications which may significantly affect contact lens wear, tear film production, pupil size, accommodation or refractive state.

• A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.

• Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.

• Any ocular, systemic or neuro-developmental conditions that could influence refractive development.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Dual Focus Soft Contact Lens

• Single Vision Soft Contact Lens

Locations

Country	Name	City	State
Canada	University of Waterloo School of Optometry	Waterloo	Ontario
Portugal	University of Minho Clinical & Experiment Optometry Research Lab	Braga
Singapore	National University of Singapore Faculty of Medicine	Singapore
United Kingdom	Aston University Ophthalmic Research Group	Birmingham

Sponsors (2)

Lead Sponsor	Collaborator
Coopervision, Inc.	Visioncare Research Ltd.

Countries where clinical trial is conducted

Canada,  Portugal,  Singapore,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Refractive Error Relative to Baseline	Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline.	12 months
Primary	Change in Refractive Error Relative to Baseline	Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline.	24 months
Primary	Change in Refractive Error Relative to Baseline	Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.	36 months
Primary	Change in Axial Length Relative to Baseline	Mean change in axial length measurement, in millimeters at 12 months, relative to baseline.	12 months
Primary	Change in Axial Length Relative to Baseline	Mean change in axial length measurement, in millimeters at 24 months, relative to baseline.	24 months
Primary	Change in Axial Length Relative to Baseline	Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.	36 months
Secondary	Number of Participants With Biomicroscopic Findings Greater Than Grade 2	Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).	Baseline
Secondary	Number of Participants With Biomicroscopic Findings Greater Than Grade 2	Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).	12 months
Secondary	Number of Participants With Biomicroscopic Findings	Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).	24 months
Secondary	Number of Participants With Biomicroscopic Findings Greater Than Grade 2.	Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).	36 months
Secondary	Incidence of Adverse Events	Cumulative incidence of adverse events.	12 months
Secondary	Incidence of Adverse Events	Cumulative incidence of adverse events.	24 months
Secondary	Incidence of Adverse Events	Cumulative incidence of adverse events.	36 months