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

NCT01829191 | Completed Results

• 1 other identifier: CR-1561AD
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and every 6 months post-baseline for 2 years

Secondary Outcomes (1)

• Axial Length

  Baseline and every 6 months for 2 years

Study Arms (2)

Test Lens A

EXPERIMENTAL

Test lenses will be worn in a daily wear modality

Device: Soft Contact Test Lens A

Test Lens C

EXPERIMENTAL

Test lenses will be worn in a daily wear modality

Device: Soft Contact Test Lens C

Interventions

Soft Contact Test Lens A DEVICE

FDA-approved, non-marketed daily disposable soft contact lens, conventional design

Test Lens A

Soft Contact Test Lens C DEVICE

Daily disposable soft contact lens with new optical design

Test Lens C

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.

  PMID: 36809645 DERIVED

• 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.

  PMID: 30994197 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: XU CHENG, PRINCIPAL CLINICAL SCIENTIST
• Organization: Vistakon, USA

xcheng6@its.jnj.com

1 904 443-1245

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 11, 2013
• Study Start: April 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 19, 2018
• Results First Posted: July 29, 2015

Record last verified: 2018-04

Locations

US (1)