CYPRESS Efficacy and Safety Study Extension

Sponsor

SightGlass Vision, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04947735

Collaborator

(none)

200

Enrollment

Locations

Arms

47.4

Anticipated Duration (Months)

18.2

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 19, 2021

Anticipated Primary Completion Date :

Apr 30, 2025

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CYPRESS Extension Test Arm Single vision, impact resistant spectacle lenses; CYPRESS Test Arm 1 and CYPRESS Test Arm 2 will move into CYPRESS Extension Test Arm	Device: Novel spectacle lens design Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia
Placebo Comparator: CYPRESS Extension Control Arm Single vision, impact resistant spectacle lenses; CYPRESS Control Arm remains in control lenses as the CYPRESS Extension Control Arm	Device: Spectacle lenses Single vision, impact resistant spectacle lenses

Arm

Intervention/Treatment

Experimental: CYPRESS Extension Test Arm

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

Device: Novel spectacle lens design

Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia

Placebo Comparator: CYPRESS Extension Control Arm

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

Device: Spectacle lenses

Single vision, impact resistant spectacle lenses

Outcome Measures

Primary Outcome Measures

Axial length [72 months]
Test vs. control axial length change from baseline
Spherical equivalent refraction (SER) [72 months]
Test vs. control spherical equivalent refraction (SER) change from baseline

Secondary Outcome Measures

Axial length [42 months]
Change from baseline
SER [60 months]
Change from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

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	Kannarr Eye Care	Pittsburg	Kansas	United States	66762
4	Eye Associates of Northeast Louisiana (DBA Haik Humble Eye Center) Research Dept	West Monroe	Louisiana	United States	71291
5	Advanced Eyecare PC	Raytown	Missouri	United States	64133
6	SUNY School of Optometry	New York	New York	United States	10036
7	Sacco Eye Group	Vestal	New York	United States	13850
8	Dunes Eye Consultants	Dakota Dunes	South Dakota	United States	57049
9	Dr. Bridgitte Shen Lee (PI)	Houston	Texas	United States	77205
10	William J Bogus, OD, FAAO	Salt Lake City	Utah	United States	84106
11	Centre for Ocular Research and Education	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

SightGlass Vision, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SightGlass Vision, Inc.

ClinicalTrials.gov Identifier:

NCT04947735

Other Study ID Numbers:

CPRO-1802-002

First Posted:

Jul 1, 2021

Last Update Posted:

Sep 13, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Myopia

Study Results

No Results Posted as of Sep 13, 2021