CYPRESS Efficacy and Safety Study Extension

NCT ID: NCT04947735

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-19

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Juvenile Myopia Myopia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Novel spectacle lens design

Intervention Type DEVICE

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

CYPRESS Extension Control Arm

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

Group Type PLACEBO_COMPARATOR

Spectacle lenses

Intervention Type DEVICE

Single vision, impact resistant spectacle lenses

Interventions

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Novel spectacle lens design

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

Intervention Type DEVICE

Spectacle lenses

Single vision, impact resistant spectacle lenses

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SightGlass Vision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Golden Optometric Group

Whittier, California, United States

Site Status

Omega Vision Center, PA

Longwood, Florida, United States

Site Status

Kannarr Eye Care

Pittsburg, Kansas, United States

Site Status

Haik Humble

West Monroe, Louisiana, United States

Site Status

Advanced Eyecare PC

Raytown, Missouri, United States

Site Status

SUNY School of Optometry

New York, New York, United States

Site Status

Sacco Eye Group

Vestal, New York, United States

Site Status

Dunes Eye Consultants

Dakota Dunes, South Dakota, United States

Site Status

Total Eye Care

Memphis, Tennessee, United States

Site Status

Dr. Bridgitte Shen Lee (PI)

Houston, Texas, United States

Site Status

William J Bogus, OD, FAAO

Salt Lake City, Utah, United States

Site Status

Centre for Ocular Research and Education

Waterloo, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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CPRO-1802-002

Identifier Type: -

Identifier Source: org_study_id