Efficacy and Safety of MiSight ® Contact Lenses in Reducing the Progression of Childhood Myopia.

NCT01917110 | Completed

• 1 other identifier: P2013/05
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to quantify the effectiveness of CooperVision MiSight® (omafilcon A) soft (hydrophilic) contact lens in slowing the rate of progression of juvenile-onset myopia.

Conditions

Myopia

Outcome Measures

Primary Outcomes (3)

• Change in the spherical equivalent refractive error relative to baseline.

  Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months

• Change in axial length relative to baseline.

  Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months

• Measurement of corneal curvature (keratometry)relative to baseline.

  Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months

Secondary Outcomes (1)

• Measurement of pupil diameter relative to baseline.

  Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months

Study Arms (2)

omafilcon A

EXPERIMENTAL

Contact Lens Group

Device: omafilcon A

Spectacle Group

ACTIVE COMPARATOR

Prescription at Baseline

Device: Spectacle

Interventions

omafilcon A DEVICE

omafilcon A

Spectacle DEVICE

Spectacle Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Prior to being considered eligible to participate in this study, each subject MUST:
• Be between 8 and 12 years of age inclusive at the baseline examination.
• Have:
• read the Informed Assent,
• been given an explanation of the Informed Assent,
• indicated an understanding of the Informed Assent and
• signed the Informed Assent Form.
• Have their parent or legal guardian:
• read the Informed Consent,
• been given an explanation of the Informed Consent,
• indicated an understanding of the Informed Consent and
• signed the Informed Consent Form.
• Along with their parent or guardian, 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, 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 accept either the control or test lens as assigned by the randomisation scheme.

You may not qualify if:

• Subjects may not be considered eligible if ANY of the following apply:
• Subject has previously or recently worn soft or rigid gas permeable contact lenses, including orthokeratology lenses.
• Subject appears to exhibit poor personal hygiene (that in the investigator's opinion might prevent safe contact lens wear).
• Subject is currently or prior to this study has been an active participant in another clinical study.
• Parent / guardian or close relative is a member, of the office staff, including the investigator(s).
• Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine or ANY other myopia control treatment.
• Subject was born earlier than 30 weeks or weighed less than 1500g (3.3lb) at birth.
• 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. Such as, but not limited to: long term use of nasal decongestants (for example, pseudoephedrine, phenylephrine), antihistamines (for example, chlorpheniramine, diphenhydramine), Prednisolone or Ritalin (methylphenidate).
• A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.
• A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections.
• Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.
• 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 could influence refractive development. Such as, but not limited to: persistent pupillary membrane, vitreous hemorrhage, cataract, corneal scarring, ptosis eyelid hemangiomas, Marfan's Syndrome, Down's syndrome, Ehler's-Danlos syndrome, Stickler's syndrome, ocular albinism, retinopathy of prematurity.
• Keratoconus or an irregular cornea.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Departamento de Óptica y Optometría de la Universidad Europea de Madrid

Madrid, Spain

Location

Related Publications (5)

• 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

• Lopes-Ferreira D, Ruiz-Pomeda A, Perez-Sanchez B, Queiros A, Villa-Collar C. Ocular and corneal aberrations changes in controlled randomized clinical trial MiSight(R) Assessment Study Spain (MASS). BMC Ophthalmol. 2021 Mar 1;21(1):112. doi: 10.1186/s12886-021-01865-y.

  PMID: 33648464 DERIVED

• Ruiz-Pomeda A, Prieto-Garrido FL, Hernandez Verdejo JL, Villa-Collar C. Rebound Effect in the Misight Assessment Study Spain (Mass). Curr Eye Res. 2021 Aug;46(8):1223-1226. doi: 10.1080/02713683.2021.1878227. Epub 2021 Jan 24.

  PMID: 33460537 DERIVED

• Ruiz-Pomeda A, Perez-Sanchez B, Canadas P, Prieto-Garrido FL, Gutierrez-Ortega R, Villa-Collar C. Binocular and accommodative function in the controlled randomized clinical trial MiSight(R) Assessment Study Spain (MASS). Graefes Arch Clin Exp Ophthalmol. 2019 Jan;257(1):207-215. doi: 10.1007/s00417-018-4115-5. Epub 2018 Sep 8.

  PMID: 30196481 DERIVED

• Ruiz-Pomeda A, Perez-Sanchez B, Valls I, Prieto-Garrido FL, Gutierrez-Ortega R, Villa-Collar C. MiSight Assessment Study Spain (MASS). A 2-year randomized clinical trial. Graefes Arch Clin Exp Ophthalmol. 2018 May;256(5):1011-1021. doi: 10.1007/s00417-018-3906-z. Epub 2018 Feb 3.

  PMID: 29396662 DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Cesar Villa Collar, OD PhD FAAO

  Departamento de Optica y Optometria de la Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 6, 2013
• Study Start: September 13, 2013
• Primary Completion: June 16, 2016
• Study Completion: June 16, 2016
• Last Updated: August 3, 2020

Record last verified: 2020-07

Locations

ES (1)