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

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01729208
• Collaborator: Visioncare Research Ltd. (Other)
• Enrollment: 144
• Locations: 4
• Arms: 2
• Actual Duration (Months): 77.9
• Patients Per Site: 36
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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.

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

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicentre Dispensing Clinical Evaluation of MiSight® Lenses
• Actual Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens	Device: Dual Focus Soft Contact Lens
Placebo Comparator: Single Vision Soft Contact Lens Single Vision Soft Contact Lens	Device: Single Vision Soft Contact Lens

Outcome Measures

Primary Outcome Measures

1. Change in Refractive Error Relative to Baseline [12 months]

   Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline.

2. Change in Refractive Error Relative to Baseline [24 months]

   Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline.

3. Change in Refractive Error Relative to Baseline [36 months]

   Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.

4. Change in Axial Length Relative to Baseline [12 months]

   Mean change in axial length measurement, in millimeters at 12 months, relative to baseline.

5. Change in Axial Length Relative to Baseline [24 months]

   Mean change in axial length measurement, in millimeters at 24 months, relative to baseline.

6. Change in Axial Length Relative to Baseline [36 months]

   Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.

Secondary Outcome Measures

1. Number of Participants With Biomicroscopic Findings Greater Than Grade 2 [Baseline]

   Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).

2. Number of Participants With Biomicroscopic Findings Greater Than Grade 2 [12 months]

   Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).

3. Number of Participants With Biomicroscopic Findings [24 months]

   Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).

4. Number of Participants With Biomicroscopic Findings Greater Than Grade 2. [36 months]

   Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).

5. Incidence of Adverse Events [12 months]

   Cumulative incidence of adverse events.

6. Incidence of Adverse Events [24 months]

   Cumulative incidence of adverse events.

7. Incidence of Adverse Events [36 months]

   Cumulative incidence of adverse events.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

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

• Principal Investigator: José Manuel González-Méijome, University of Minho

Study Documents (Full-Text)

• Study Protocol - Jul 26, 2012
• Statistical Analysis Plan - Apr 30, 2018

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT01729208
• Other Study ID Numbers: CVI08008
• First Posted: Nov 20, 2012
• Last Update Posted: Feb 24, 2020
• Last Verified: Feb 1, 2020

• 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 progression; myopia control
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens
Arm/Group Description	Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens Single Vision Soft Contact Lens
Period Title: Baseline
STARTED	70	74
COMPLETED	65	70
NOT COMPLETED	5	4
Period Title: Baseline
STARTED	65	70
COMPLETED	58	60
NOT COMPLETED	7	10
Period Title: Baseline
STARTED	58	60
COMPLETED	55	60
NOT COMPLETED	3	0
Period Title: Baseline
STARTED	55	60
COMPLETED	52	56
NOT COMPLETED	3	4

Baseline Characteristics

Arm/Group Title	Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens	Total
Arm/Group Description	Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens Single Vision Soft Contact Lens	Total of all reporting groups
Overall Participants	70	74	144
Age (Count of Participants)
<=18 years	70 100%	74 100%	144 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10.1 (1.3)	10.1 (1.4)	10.1 (1.3)
Sex: Female, Male (Count of Participants)
Female	32 45.7%	37 50%	69 47.9%
Male	38 54.3%	37 50%	75 52.1%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	39 55.7%	40 54.1%	79 54.9%
East Asian	16 22.9%	18 24.3%	34 23.6%
Indian/Pakistani/Sri Lankan	5 7.1%	7 9.5%	12 8.3%
Other	2 2.9%	4 5.4%	6 4.2%
Mixed	8 11.4%	5 6.8%	13 9%
Region of Enrollment (Count of Participants)
Canada	32 45.7%	32 43.2%	64 44.4%
Singapore	15 21.4%	16 21.6%	31 21.5%
United Kingdom	13 18.6%	15 20.3%	28 19.4%
Portugal	10 14.3%	11 14.9%	21 14.6%

Outcome Measures

1. Primary Outcome

Title	Change in Refractive Error Relative to Baseline
Description	Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens
Arm/Group Description	Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens Single Vision Soft Contact Lens
Measure Participants	58	60
Measure Eyes	116	120
Mean (Standard Deviation) [Diopters]	-0.18 (0.39)	-0.58 (0.41)

2. Primary Outcome

Title	Change in Refractive Error Relative to Baseline
Description	Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens
Arm/Group Description	Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens Single Vision Soft Contact Lens
Measure Participants	55	60
Measure Eyes	110	120
Mean (Standard Deviation) [Diopters]	-0.38 (0.52)	-0.92 (0.53)

3. Primary Outcome

Title	Change in Refractive Error Relative to Baseline
Description	Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens
Arm/Group Description	Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens Single Vision Soft Contact Lens
Measure Participants	52	56
Measure Eyes	104	112
Mean (Standard Deviation) [Diopters]	-0.51 (0.64)	-1.24 (0.61)

4. Primary Outcome

Title	Change in Axial Length Relative to Baseline
Description	Mean change in axial length measurement, in millimeters at 12 months, relative to baseline.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens
Arm/Group Description	Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens Single Vision Soft Contact Lens
Measure Participants	58	60
Measure Eyes	116	120
Mean (Standard Deviation) [mm]	0.09 (0.13)	0.24 (0.15)

5. Primary Outcome

Title	Change in Axial Length Relative to Baseline
Description	Mean change in axial length measurement, in millimeters at 24 months, relative to baseline.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens
Arm/Group Description	Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens Single Vision Soft Contact Lens
Measure Participants	55	60
Measure Eyes	110	120
Mean (Standard Deviation) [mm]	0.21 (0.22)	0.45 (0.23)

6. Primary Outcome

Title	Change in Axial Length Relative to Baseline
Description	Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens
Arm/Group Description	Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens Single Vision Soft Contact Lens
Measure Participants	52	56
Measure Eyes	104	112
Mean (Standard Deviation) [mm]	0.30 (0.28)	0.62 (0.30)

7. Secondary Outcome

Title	Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Description	Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens
Arm/Group Description	Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens Single Vision Soft Contact Lens
Measure Participants	70	74
Corneal Staining	0 0%	0 0%
Conjuctival Staining	0 0%	0 0%
Bulbar Hyperemia	0 0%	0 0%
Limbal Hyperemia	0 0%	0 0%
Palpebral Hyperemia	0 0%	0 0%
Palpebral Roughness	0 0%	0 0%
Vascularization	0 0%	0 0%
"Other" Findings	0 0%	0 0%

8. Secondary Outcome

Title	Number of Participants With Biomicroscopic Findings Greater Than Grade 2
Description	Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens
Arm/Group Description	Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens Single Vision Soft Contact Lens
Measure Participants	58	60
Corneal Staining	0 0%	0 0%
Conjuctival Staining	0 0%	0 0%
Bulbar Hyperemia	0 0%	0 0%
Limbal Hyperemia	0 0%	0 0%
Palpebral Hyperemia	0 0%	0 0%
Palpebral Roughness	1 1.4%	0 0%
Vascularization	0 0%	0 0%
"Other" Findings	0 0%	0 0%

9. Secondary Outcome

Title	Number of Participants With Biomicroscopic Findings
Description	Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens
Arm/Group Description	Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens Single Vision Soft Contact Lens
Measure Participants	55	60
Corneal Staining	0 0%	0 0%
Conjuctival Staining	0 0%	0 0%
Bulbar Hyperemia	0 0%	0 0%
Limbal Hyperemia	0 0%	0 0%
Palpebral Hyperemia	0 0%	0 0%
Palpebral Roughness	0 0%	0 0%
Vascularization	0 0%	0 0%
"Other" Findings	0 0%	0 0%

10. Secondary Outcome

Title	Number of Participants With Biomicroscopic Findings Greater Than Grade 2.
Description	Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens
Arm/Group Description	Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens Single Vision Soft Contact Lens
Measure Participants	52	56
Corneal Staining	0 0%	0 0%
Conjuctival Staining	0 0%	0 0%
Bulbar Hyperemia	0 0%	0 0%
Limbal Hyperemia	0 0%	0 0%
Palpebral Hyperemia	0 0%	0 0%
Palpebral Roughness	0 0%	0 0%
Vascularization	0 0%	0 0%
"Other" Findings	0 0%	0 0%

11. Secondary Outcome

Title	Incidence of Adverse Events
Description	Cumulative incidence of adverse events.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens
Arm/Group Description	Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens Single Vision Soft Contact Lens
Measure Participants	58	60
Non-significant infiltrative event- device related	0 0%	2 2.7%
Blepharitis - not device related	2 2.9%	0 0%
Localized allergic reaction - device related	0 0%	1 1.4%
Localized allergic reaction-not device related	0 0%	1 1.4%
Non-significant-Other-Device related	2 2.9%	0 0%
Non-significant-Other- Not device related	3 4.3%	0 0%
Foreign Body -Device related	1 1.4%	0 0%
Corneal event -Device related	3 4.3%	0 0%
Corneal event- Not device related	1 1.4%	0 0%
Meibomianitis - Not device related	2 2.9%	0 0%
Significant adverse events	0 0%	0 0%

12. Secondary Outcome

Title	Incidence of Adverse Events
Description	Cumulative incidence of adverse events.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens
Arm/Group Description	Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens Single Vision Soft Contact Lens
Measure Participants	55	60
Conjuctivitis - Not device related	2 2.9%	0 0%
Non-significant Other - Device related	1 1.4%	0 0%
Non-significant Other - Not device related	0 0%	3 4.1%
Non-significant infiltrative event Device related	0 0%	1 1.4%
Significant Adverse Events	0 0%	0 0%

13. Secondary Outcome

Title	Incidence of Adverse Events
Description	Cumulative incidence of adverse events.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens
Arm/Group Description	Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens	Single Vision Soft Contact Lens Single Vision Soft Contact Lens
Measure Participants	52	56
Conjuctivitis - Not device related	0 0%	1 1.4%
Non-significant Other - Device related	0 0%	1 1.4%
Non-significant Other - Not device related	0 0%	1 1.4%
Non-significant infiltrative event-no device relat	1 1.4%	0 0%
Corneal event- device related	0 0%	1 1.4%
Significant Adverse Events	0 0%	0 0%

Adverse Events

Time Frame	From dispense of soft contact lenses till 36 months follow-up visit.
Arm/Group Title	Dual Focus Soft Contact Lens		Single Vision Soft Contact Lens
Arm/Group Description	Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens		Single Vision Soft Contact Lens Single Vision Soft Contact Lens
All Cause Mortality
	Dual Focus Soft Contact Lens		Single Vision Soft Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/74 (0%)
Serious Adverse Events
	Dual Focus Soft Contact Lens		Single Vision Soft Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/74 (0%)
Other (Not Including Serious) Adverse Events
	Dual Focus Soft Contact Lens		Single Vision Soft Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/74 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.