CYPRESS Efficacy and Safety Study Extension

Myopia Clinical Trial

— CYPRESS  

Official title:

Control of Myopia Using Peripheral Diffusion Lenses: Efficacy and Safety Study Extension

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04947735
• Other study ID #: CPRO-1802-002
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 19, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: SightGlass Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Juvenile Myopia
• Myopia

Intervention

Device:
• Novel spectacle lens design
Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia
• Spectacle lenses
Single vision, impact resistant spectacle lenses

Locations

Country	Name	City	State
Canada	Centre for Ocular Research and Education	Waterloo	Ontario
United States	Dunes Eye Consultants	Dakota Dunes	South Dakota
United States	Dr. Bridgitte Shen Lee (PI)	Houston	Texas
United States	Omega Vision Center, PA	Longwood	Florida
United States	Total Eye Care	Memphis	Tennessee
United States	SUNY School of Optometry	New York	New York
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	Advanced Eyecare PC	Raytown	Missouri
United States	William J Bogus, OD, FAAO	Salt Lake City	Utah
United States	Sacco Eye Group	Vestal	New York
United States	Haik Humble	West Monroe	Louisiana
United States	Golden Optometric Group	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
SightGlass Vision, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial length	Test vs. control axial length change from baseline	72 months
Primary	Spherical equivalent refraction (SER)	Test vs. control spherical equivalent refraction (SER) change from baseline	72 months
Secondary	Axial length	Change from baseline	42 months
Secondary	SER	Change from baseline	60 months