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MyopiaNCT01917110

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

A study testing omafilcon A and Spectacle in people with Myopia, run by CooperVision, Inc. at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 12 years
Conditions the study is for
Myopia
What is being tested?
omafilcon A and Spectacle
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
1 siteSpain
Study dates
13 Sep 2013to 16 Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
Show all 23Show fewer
  • 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.
  • Agree to wear the assigned contact lenses for the duration of the 2 year study and to inform the study investigator if this schedule is interrupted. (Wearing time may be modified by the study staff for health reasons.)
  • Possess wearable and visually functional eyeglasses.
  • Be in good general health, based on his/her and parent's/guardian's knowledge.
  • Have best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye.
  • Meet the following refractive criteria determined by cycloplegic autorefraction at baseline:
  • Spherical Equivalent Refractive Error (SERE): between -0.75 and -4.00 D inclusive.
  • Astigmatism: < -0.75 D
  • Anisometropia: < 1.00D

Who cannot join

  • 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.
Show all 24Show fewer
  • 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.
  • Biomicroscope findings that would contraindicate contact lens wear including, but not limited to:
  • corneal scars within the visual axis
  • neovascularisation or ghost vessels > 1.5 mm in from the limbus
  • Any active anterior segment ocular disease that would contraindicate contact lens wear.
  • giant papillary conjunctivitis of Grade 2 or worse
  • allergic or seasonal conjunctivitis (if the study investigator believes it could significantly interfere with maintaining the specified contact lens wearing schedule)
  • clinically significant (Grade 3 or 4) abnormalities of the anterior segment, lids, conjunctiva, sclera or associated structures.
  • The investigator for any reason considers that it is not in the best interest of the subject to participate in the study.
  • Have pathological myopia To be eligible to begin the study, a subject must have ALL of the inclusion criteria and NONE of the exclusion criteria present.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Departamento de Óptica y Optometría de la Universidad Europea de Madrid

    Madrid

Other trials in Spain

About this study

Official title: Efficacy and Safety of MiSight ® Contact Lenses in Reducing the Progression of Childhood Myopia, Not Pathological, Aged 8-12 Years Randomized Clinical Trial.

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.

Read the detailed description

Subjects in two parallel groups were randomized and assigned to either the study contact lens (omafilcon a) or single vision spectacles.

Conditions
Myopia
Being tested
omafilcon A, Spectacle
Medical subject headings
Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • omafilcon ADevice

  • SpectacleDevice

Study groups in NCT01917110
Study groupRoleWhat they receive
omafilcon AExperimentalContact Lens Group
Receives: Device: omafilcon A
Spectacle GroupActive comparatorPrescription at Baseline
Receives: Device: Spectacle

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

  2. Change in axial length relative to baseline.

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

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

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

Secondary outcomes (1)

  1. Measurement of pupil diameter relative to baseline.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2013 (estimated)
  2. Study start13 Sep 2013
  3. Primary completion16 Jun 2016
  4. Study completion16 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01917110
Sponsor's protocol ID
P2013/05
Status last verified
Jul 2020
First submitted
2 Aug 2013
Last updated
3 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36809645

  • 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.

    PubMed 33648464

  • 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.

    PubMed 33460537

  • 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.

    PubMed 30196481

  • 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.

    PubMed 29396662

Questions about this trial

What is this clinical trial studying?

A study testing omafilcon A and Spectacle in people with Myopia, run by CooperVision, Inc. at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the spherical equivalent refractive error relative to baseline. (time frame: Baseline, 1 week, 1 month, 6 months, 12 months, 18 months, 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01917110, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.

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