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CYPRESS: Control of Myopia Using Novel Spectacle Lens Designs

Sponsor
SightGlass Vision, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03623074
Collaborator
(none)
266
Enrollment
14
Locations
3
Arms
42.5
Anticipated Duration (Months)
19
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Novel spectacle lens design
  • Device: Spectacle lenses
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
266 participants
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
Official Title:
Efficacy and Safety Study of Novel Spectacle Lens Designs to Control of Myopia
Actual Study Start Date :
Jul 16, 2018
Anticipated Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Jan 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test Arm 1

Single vision, impact-resistant spectacle lenses

Device: Novel spectacle lens design
Use of lenses may reduce the rate of progression of juvenile myopia
Experimental: Test Arm 2

Single vision, impact-resistant spectacle lenses

Device: Novel spectacle lens design
Use of lenses may reduce the rate of progression of juvenile myopia
Other: Test Arm 3

Single vision, impact-resistant spectacle lenses

Device: Spectacle lenses
Use of lenses may reduce the rate of progression of juvenile myopia

Outcome Measures

Primary Outcome Measures

  1. Axial length [36 Months]

    Change in axial length from baseline

  2. Spherical equivalent refraction [36 Months]

    Change in spherical equivalent refraction from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Golden Optometric Group Whittier California United States 90606
2 Sabal Eye Care Longwood Florida United States 32779
3 Visual Performance Center Pensacola Florida United States 32503
4 Kannarr Eye Care Pittsburg Kansas United States 66762
5 Eye Associates of Northeast Louisiana (DBA Haik Humble Eye Center) Research Dept West Monroe Louisiana United States 71291
6 Advanced Eyecare, PC Raytown Missouri United States 64133
7 SUNY School of Optometry New York New York United States 10036
8 Sacco Eye Group Vestal New York United States 13850
9 Dept of Clinical Research, South Shore Eye Care, LLP Wantagh New York United States 11793
10 Dunes Eye Consultants Dakota Dunes South Dakota United States 57049
11 Total Eye Care Memphis Tennessee United States 38119
12 University of Houston College of Optometry Houston Texas United States 77204
13 William J Bogus, OD, FAAO Salt Lake City Utah United States 84106
14 Center for Ocular Research & Education, School of Optometry, University of Waterloo School of Optometry & Vision Science Waterloo Ontario Canada N2L 3G1

Sponsors and Collaborators

  • SightGlass Vision, Inc.

Investigators

  • Study Chair: Joseph Rappon, OD, MS, FAAO, SightGlass Vision, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SightGlass Vision, Inc.
ClinicalTrials.gov Identifier:
NCT03623074
Other Study ID Numbers:
  • CPRO-1802-001
First Posted:
Aug 9, 2018
Last Update Posted:
Sep 13, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by SightGlass Vision, Inc.
Myopia
Additional relevant MeSH terms:
Myopia

Study Results

No Results Posted as of Sep 13, 2021