Back to resultsControl of Myopia Using Novel Spectacle Lens Designs (CYPRESS)
Primary Purpose
Juvenile Myopia
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Novel spectacle lens design
Spectacle lenses
Sponsored by
About this trial
This is an interventional treatment trial for Juvenile Myopia focused on measuring Myopia
Eligibility Criteria
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
Sites / Locations
- Golden Optometric Group
- Sabal Eye Care
- Visual Performance Center
- Kannarr Eye Care
- Eye Associates of Northeast Louisiana (DBA Haik Humble Eye Center) Research Dept
- Advanced Eyecare, PC
- SUNY School of Optometry
- Sacco Eye Group
- Dept of Clinical Research, South Shore Eye Care, LLP
- Dunes Eye Consultants
- Total Eye Care
- University of Houston College of Optometry
- William J Bogus, OD, FAAO
- Center for Ocular Research & Education, School of Optometry, University of Waterloo School of Optometry & Vision Science
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Test Arm 1
Test Arm 2
Test Arm 3
Arm Description
Single vision, impact-resistant spectacle lenses
Single vision, impact-resistant spectacle lenses
Single vision, impact-resistant spectacle lenses
Outcomes
Primary Outcome Measures
Axial length
Change in axial length from baseline
Spherical equivalent refraction
Change in spherical equivalent refraction from baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03623074
Brief Title
Control of Myopia Using Novel Spectacle Lens Designs
Acronym
CYPRESS
Official Title
Efficacy and Safety Study of Novel Spectacle Lens Designs to Control of Myopia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 16, 2018 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SightGlass Vision, Inc.
4. Oversight
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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Myopia
Keywords
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
266 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Arm 1
Arm Type
Experimental
Arm Description
Single vision, impact-resistant spectacle lenses
Arm Title
Test Arm 2
Arm Type
Experimental
Arm Description
Single vision, impact-resistant spectacle lenses
Arm Title
Test Arm 3
Arm Type
Other
Arm Description
Single vision, impact-resistant spectacle lenses
Intervention Type
Device
Intervention Name(s)
Novel spectacle lens design
Intervention Description
Use of lenses may reduce the rate of progression of juvenile myopia
Intervention Type
Device
Intervention Name(s)
Spectacle lenses
Intervention Description
Use of lenses may reduce the rate of progression of juvenile myopia
Primary Outcome Measure Information:
Title
Axial length
Description
Change in axial length from baseline
Time Frame
36 Months
Title
Spherical equivalent refraction
Description
Change in spherical equivalent refraction from baseline
Time Frame
36 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Rappon, OD, MS, FAAO
Organizational Affiliation
SightGlass Vision, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Golden Optometric Group
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Facility Name
Sabal Eye Care
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Visual Performance Center
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Kannarr Eye Care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Eye Associates of Northeast Louisiana (DBA Haik Humble Eye Center) Research Dept
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Facility Name
Advanced Eyecare, PC
City
Raytown
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
SUNY School of Optometry
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Sacco Eye Group
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Facility Name
Dept of Clinical Research, South Shore Eye Care, LLP
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
Facility Name
Dunes Eye Consultants
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Facility Name
Total Eye Care
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
University of Houston College of Optometry
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Facility Name
William J Bogus, OD, FAAO
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Center for Ocular Research & Education, School of Optometry, University of Waterloo School of Optometry & Vision Science
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Control of Myopia Using Novel Spectacle Lens Designs
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