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Control of Myopia Using Novel Spectacle Lens Designs (CYPRESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03623074
Recruitment Status : Active, not recruiting
First Posted : August 9, 2018
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
SightGlass Vision, Inc.

Tracking Information
First Submitted Date  ICMJE August 3, 2018
First Posted Date  ICMJE August 9, 2018
Last Update Posted Date May 3, 2019
Actual Study Start Date  ICMJE July 16, 2018
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • Axial length [ Time Frame: 36 Months ]
    Change in axial length from baseline
  • Spherical equivalent refraction [ Time Frame: 36 Months ]
    Change in spherical equivalent refraction from baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03623074 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Control of Myopia Using Novel Spectacle Lens Designs
Official Title  ICMJE Efficacy and Safety Study of Novel Spectacle Lens Designs to Control of Myopia
Brief Summary Randomized, controlled, multisite, subject-and observer-masked, 3-arm parallel group clinical trial of 36-month duration to evaluate the safety and efficacy of a novel spectacle lens design in reducing the progression of juvenile myopia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Participants and parents of participants will be masked. Investigational site staff tasked with measuring key primary variables (i.e., axial length and SER) will be masked.
Primary Purpose: Treatment
Condition  ICMJE Juvenile Myopia
Intervention  ICMJE
  • Device: Novel spectacle lens design
    Use of lenses may reduce the rate of progression of juvenile myopia
  • Device: Spectacle lenses
    Use of lenses may reduce the rate of progression of juvenile myopia
Study Arms  ICMJE
  • Experimental: Test Arm 1
    Single vision, impact-resistant spectacle lenses
    Intervention: Device: Novel spectacle lens design
  • Experimental: Test Arm 2
    Single vision, impact-resistant spectacle lenses
    Intervention: Device: Novel spectacle lens design
  • Test Arm 3
    Single vision, impact-resistant spectacle lenses
    Intervention: Device: Spectacle lenses
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 1, 2019)
266
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2018)
255
Estimated Study Completion Date  ICMJE January 31, 2022
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children 6-10 years of age (day prior to 10th birthday) at time of informed consent/assent
  • SER error between -0.75 and -4.50 D
  • SER power between the two eyes must be less than or equal to 1.50 D
  • Willingness to participate in the trial for 3 years without content lens wear

Exclusion Criteria:

  • Previous or current use of contact lenses
  • Previous or current use of bifocals, progressive addition spectacles lenses
  • Previous or current use of myopia control treatment
  • Astigmatism worse then -1.25 DC in either eye
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03623074
Other Study ID Numbers  ICMJE CPRO-1802-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SightGlass Vision, Inc.
Study Sponsor  ICMJE SightGlass Vision, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Joseph Rappon, OD, MS, FAAO SightGlass Vision, Inc.
PRS Account SightGlass Vision, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP