CYPRESS Efficacy and Safety Study Extension

SightGlass Vision

Status: Active, not recruiting

Conditions: Myopia; Juvenile Myopia

Treatments: Device: Novel spectacle lens design; Device: Spectacle lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT04947735

CPRO-1802-002

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

CYPRESS Extension Test Arm

Experimental group

Description:

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

Treatment:

Device: Novel spectacle lens design

CYPRESS Extension Control Arm

Placebo Comparator group

Description:

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

Treatment:

Device: Spectacle lenses