CompletedNCT01829191Updated Jun 19, 2018Results posted

Controlling Myopia Progression With Soft Contact Lenses (Contact Lens Control)

An interventional study of Soft Contact Test Lens A and Soft Contact Test Lens C in Myopia, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 1 site in United States. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-19.

Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 5 years after the study started (first participant enrolled Apr 2008, registered Apr 2013).

Phase: Not applicable
Study type: Interventional
Enrollment: 174
Allocation: Randomized
Ages: 8 Years to 12 Years
Sex: All

Study summary

This study is to investigate whether novel soft contact lens optical designs can slow myopia progression

Conditions studied

Myopia

Browse trials for

Myopia 984

In context

Myopia

984 studies on the registry are indexed under Myopia; 209 are open to participants now.

This study's enrollment of 174 is above the median of 80 across 782 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 8 Years to 12 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

The subject must be between 8 and 12 years of age.
At least one of the subject's parents or legal guardian must read and understand English or Chinese.
The subject's manifest objective refraction (measured with an auto refractor) must be sphere: between -0.25D and -4.50D, and cylinder: \<1.50D in each eye.
The subject's best sphere contact lens correction must lie between -0.75D (better of the two eyes)and -4.25D (poorer of the two eyes).
The subject's cycloplegic objective refraction must be here: between -0.75D and -4.00D cylinder: \< or equal to 1.00D in each eye.
The subject must have 1.00D or less difference in spherical equivalent between the two eyes with cycloplegic refraction.
The subject must have a spectacle lens best-corrected visual acuity of 0.8 (20/25) or better in both eyes.
The subject's parent or legal guardian must read and sign the STAEMENT OF INFORMED CONSENT and the subject must read and sign the Child's Assent Form and be provided a copy of each form.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion criteria

Exclusion Criteria:

Ocular or systemic allergies or diseases that may interfere with contact lens wear.
Systemic disease or autoimmune disease or use of medications (e.g. antihistamine), which may interfere with contact lens wear.
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormality of the cornea, which may contraindicate contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
Any ocular infection.
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Any infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV)
Diabetes
Anisometropia of greater than 1.00D by cycloplegic refraction.
Astigmatism of greater than 1.00D in either eye by cycloplegic refraction.
Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study unless they are off rigid contact lenses for at least 4 weeks.
Strabismus in either eye.
Pupil or lid abnormality or infection in either eye
Central corneal scar in either eye
Aphakia in either eye
Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear.
History of participation in prior clinical trials aimed to control myopia progression.
Surgically altered eyes, ocular infection of any type, ocular inflammation.
An anterior chamber angle grade 2 or narrower by the Van Herrick method

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 174 participants (actual)

Study arms

Experimental
Test Lens A
Test lenses will be worn in a daily wear modality
Device: Soft Contact Test Lens A
Experimental
Test Lens C
Test lenses will be worn in a daily wear modality
Device: Soft Contact Test Lens C

Interventions

DeviceSoft Contact Test Lens A
FDA-approved, non-marketed daily disposable soft contact lens, conventional design
DeviceSoft Contact Test Lens C
Daily disposable soft contact lens with new optical design

What researchers measure

Primary outcomes

Spherical Equivalent Refractive Error
Cycloplegic spherical equivalent auto refraction of the subject's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measures, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values in spherical refraction indicate progression in Myopia.
Time frame: Baseline and every 6 months post-baseline for 2 years

Secondary outcomes

Axial Length
Axial length was measured with the IOLMaster at baseline and every 6 months for 2 years. Five measurements were collected for each visit from the subject's right eye and the average of the five measurements was used for the analysis.
Time frame: Baseline and every 6 months for 2 years

Results

Posted Jul 29, 2015

Participant flow

Participant flow — Overall Study
Milestone	Test Lens A	Test Lens C
Started	63	64
Completed	56	50
Not completed	7	14
Withdrew: Relocation	0	1
Withdrew: Lens discomfort	0	3
Withdrew: Lens handling difficulty	1	4
Withdrew: Protocol violation	4	1
Withdrew: Withdrawal by subject	2	3
Withdrew: Lost to follow-up	0	1
Withdrew: Subject was fit for ortho - k	0	1

Outcome measures

PrimarySpherical Equivalent Refractive Error

Cycloplegic spherical equivalent auto refraction of the subject's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measures, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values in spherical refraction indicate progression in Myopia.

Time frame:: Baseline and every 6 months post-baseline for 2 years
Reported as:: Mean · diopter (D)

Spherical Equivalent Refractive Error
diopter (D)	Test Lens A	Test Lens C
Change from baseline 6 months	-0.386 ± 0.3270	-0.185 ± 0.2873
Change from baseline 12 months	-0.679 ± 0.5253	-0.548 ± 0.4050
Change from baseline 18 months	-0.934 ± 0.4761	-0.614 ± 0.4140
Change from baseline 24 months	-1.054 ± 0.4559	-1.080 ± 0.6800

SecondaryAxial Length

Axial length was measured with the IOLMaster at baseline and every 6 months for 2 years. Five measurements were collected for each visit from the subject's right eye and the average of the five measurements was used for the analysis.

Time frame:: Baseline and every 6 months for 2 years
Reported as:: Mean · millimeter (mm)

Axial Length
millimeter (mm)	Test Lens A	Test Lens C
Change from baseline 6 months	0.172 ± 0.1029	0.061 ± 0.1038
Change from baseline 12 months	0.371 ± 0.1471	0.229 ± 0.1581
Change from baseline 18 months	0.479 ± 0.2049	0.313 ± 0.1946
Change from baseline 24 months	0.545 ± 0.2177	0.514 ± 0.2808

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
All Subjects	—	0/132 (0%)	0/132 (0%)

Baseline characteristics

Baseline summary was conducted on all subjects who randomized in the study.

Age, Categorical
Age, Categorical(Participants)	Test Lens A	Test Lens C	Total
<=18 years	63	64	127
Between 18 and 65 years	0	0	0
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Test Lens A	Test Lens C	Total
Mean	9.7 ± 1.1	9.7 ± 1.1	9.7 ± 1.1

Sex: Female, Male
Sex: Female, Male(Participants)	Test Lens A	Test Lens C	Total
Female	34	34	68
Male	29	30	59

Region of Enrollment
Region of Enrollment(Participants)	Test Lens A	Test Lens C	Total
United States	63	64	127

Study locations

1 site

Boston, Massachusetts 02115, United States

References and documents

Publications

Cheng X, Xu J, Brennan NA. Accommodation and its role in myopia progression and control with soft contact lenses. Ophthalmic Physiol Opt. 2019 May;39(3):162-171. doi: 10.1111/opo.12614. PubMed 30994197 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01829191
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Responsible party: Sponsor
First posted: Apr 11, 2013
Start date: Apr 1, 2008
Primary completion: May 1, 2010
Completion: May 1, 2010
Results posted: Jul 29, 2015
Last update: Jun 19, 2018

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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