CEDAR: Spectacle Lens Visual Acuity Assessments Study

Sponsor

SightGlass Vision, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05650190

Collaborator

(none)

Enrollment

Locations

Arms

3.8

Anticipated Duration (Months)

8.3

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Spectacle Lenses Visual Acuity Assessments Study

Anticipated Study Start Date :

Dec 5, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Arm Single vision, impact resistant spectacle lenses; 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: Control Arm Single vision, impact resistant spectacle lenses; Control Arm	Device: Spectacle lenses Single vision, impact resistant spectacle lenses

Arm

Intervention/Treatment

Experimental: Test Arm

Single vision, impact resistant spectacle lenses; 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: Control Arm

Single vision, impact resistant spectacle lenses; Control Arm

Device: Spectacle lenses

Single vision, impact resistant spectacle lenses

Outcome Measures

Primary Outcome Measures

Visual Acuity [15 minutes]
Reading Speed (maximum words per minute)

Secondary Outcome Measures

Near Visual Acuity with Glare [15 minutes]
Mean and Standard Deviation at 15 minutes (short duration test)

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sabal Eye Care	Longwood	Florida	United States	32779
2	Kannarr Eye Care	Pittsburg	Kansas	United States	66762
3	Advanced Eyecare PC	Raytown	Missouri	United States	64133
4	SUNY School of Optometry	New York	New York	United States	10036
5	Vision Optique	Houston	Texas	United States	77205
6	William J Bogus, OD, FAAO	Salt Lake City	Utah	United States	84106

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:

NCT05650190

Other Study ID Numbers:

CPRO-2209-001

First Posted:

Dec 14, 2022

Last Update Posted:

Dec 14, 2022

Last Verified:

Nov 1, 2022

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 Dec 14, 2022