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CYPRESS Efficacy and Safety Study Extension (CYPRESS)

Primary Purpose

Juvenile Myopia, Myopia

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Novel spectacle lens design
Spectacle lenses
Sponsored by
SightGlass Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Myopia

Eligibility Criteria

6 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Previously a successfully completed participant in the CYPRESS study (NCT03623074) and having not exited this study for more than 30 days;
  • Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
  • Willingness to participate in the trial for up to 3 years without contact lens wear;
  • The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.

Exclusion Criteria:

  • Known allergy to proparacaine, tetracaine, or tropicamide.

Sites / Locations

  • Golden Optometric Group
  • Sabal Eye Care
  • Kannarr Eye Care
  • Haik Humble
  • Advanced Eyecare PC
  • SUNY School of Optometry
  • Sacco Eye Group
  • Dunes Eye Consultants
  • Total Eye Care
  • Dr. Bridgitte Shen Lee (PI)
  • William J Bogus, OD, FAAO
  • Centre for Ocular Research and Education

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CYPRESS Extension Test Arm

CYPRESS Extension Control Arm

Arm Description

Single vision, impact resistant spectacle lenses; CYPRESS Test Arm 1 and CYPRESS Test Arm 2 will move into CYPRESS Extension Test Arm

Single vision, impact resistant spectacle lenses; CYPRESS Control Arm remains in control lenses as the CYPRESS Extension Control Arm

Outcomes

Primary Outcome Measures

Axial length
Test vs. control axial length change from baseline
Spherical equivalent refraction (SER)
Test vs. control spherical equivalent refraction (SER) change from baseline

Secondary Outcome Measures

Axial length
Change from baseline
SER
Change from baseline

Full Information

First Posted
June 18, 2021
Last Updated
September 28, 2022
Sponsor
SightGlass Vision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04947735
Brief Title
CYPRESS Efficacy and Safety Study Extension
Acronym
CYPRESS
Official Title
Control of Myopia Using Peripheral Diffusion Lenses: Efficacy and Safety Study Extension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (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.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an open-label, controlled, multisite, two-arm parallel group clinical trial of 36-month duration to evaluate the continued safety and efficacy of SightGlass Vision Diffusion Optics Technology (DOT) Spectacles 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, Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CYPRESS Extension Test Arm
Arm Type
Experimental
Arm Description
Single vision, impact resistant spectacle lenses; CYPRESS Test Arm 1 and CYPRESS Test Arm 2 will move into CYPRESS Extension Test Arm
Arm Title
CYPRESS Extension Control Arm
Arm Type
Placebo Comparator
Arm Description
Single vision, impact resistant spectacle lenses; CYPRESS Control Arm remains in control lenses as the CYPRESS Extension Control Arm
Intervention Type
Device
Intervention Name(s)
Novel spectacle lens design
Intervention Description
Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia
Intervention Type
Device
Intervention Name(s)
Spectacle lenses
Intervention Description
Single vision, impact resistant spectacle lenses
Primary Outcome Measure Information:
Title
Axial length
Description
Test vs. control axial length change from baseline
Time Frame
72 months
Title
Spherical equivalent refraction (SER)
Description
Test vs. control spherical equivalent refraction (SER) change from baseline
Time Frame
72 months
Secondary Outcome Measure Information:
Title
Axial length
Description
Change from baseline
Time Frame
42 months
Title
SER
Description
Change from baseline
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Previously a successfully completed participant in the CYPRESS study (NCT03623074) and having not exited this study for more than 30 days; Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day); Willingness to participate in the trial for up to 3 years without contact lens wear; The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form. Exclusion Criteria: Known allergy to proparacaine, tetracaine, or tropicamide.
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
Kannarr Eye Care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Haik Humble
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
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
Dr. Bridgitte Shen Lee (PI)
City
Houston
State/Province
Texas
ZIP/Postal Code
77205
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
Centre for Ocular Research and Education
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

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CYPRESS Efficacy and Safety Study Extension

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