NCT05650190

Brief Summary

This is a two-arm parallel group, non-dispensing study. Participants will be existing active CYPRESS Extension (CPRO-1802-002) subjects. Subjects will undergo additional visual performance assessments.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Dec 2022Dec 2026

First Submitted

Initial submission to the registry

November 28, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

December 8, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2023

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

November 28, 2022

Last Update Submit

April 29, 2026

Conditions

MyopiaMyopia ProgressionJuvenile Myopia

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    Reading Speed (maximum words per minute)

    15 minutes

Secondary Outcomes (1)

  • Near Visual Acuity with Glare

    15 minutes

Study Arms (2)

Test Arm

EXPERIMENTAL

Single vision, impact resistant spectacle lenses; Test Arm

Device: Novel spectacle lens design

Control Arm

PLACEBO COMPARATOR

Single vision, impact resistant spectacle lenses; Control Arm

Device: Spectacle lenses

Interventions

Novel spectacle lens designDEVICE

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

Test Arm
Spectacle lensesDEVICE

Single vision, impact resistant spectacle lenses

Control Arm

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Existing subject from the CYPRESS Extension study (CPRO-1802-002)
  • Ability to comply with study assessments
  • The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed coy of the form

You may not qualify if:

  • Any current ocular infection, inflammation or irritation likely to affect vision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Sabal Eye Care

Longwood, Florida, 32779, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Advanced Eyecare PC

Raytown, Missouri, 64133, United States

Location

SUNY School of Optometry

New York, New York, 10036, United States

Location

Vision Optique

Houston, Texas, 77205, United States

Location

William J Bogus, OD, FAAO

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 14, 2022

Study Start

December 8, 2022

Primary Completion

February 10, 2023

Study Completion (Estimated)

December 31, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

US(6)