Clinical Evaluation of Biomedics Monthly Toric and Avaira Vitality Toric

CooperVision, Inc.1 site in 1 country40 target enrollmentMay 24, 2024

ConditionsAstigmatism

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Astigmatism
Sponsor: CooperVision, Inc.
Enrollment: 40
Locations: 1
Primary Endpoint: Overall Fit Acceptance
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to compare the short-term clinical performance of two toric contact lenses.

Detailed Description

The aim of this study is to evaluate the short-term clinical performance of two toric contact lenses when compared to each other after 15 minutes of daily wear each.

Registry

clinicaltrials.gov

Start Date

May 24, 2024

End Date

June 28, 2024

Last Updated

8 months ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

CooperVision, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Is between 18 and 40 years of age (inclusive)
•Has had a self-reported visual exam in the last two years.
•Is an adapted soft contact lens wearer.
•Is not a habitual wearer of either study lens.
•Has a contact lens spherical prescription between +5.00 to -9.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye.
•Have contact lens prescription of no less than -0.75D of astigmatism and no more than -2.25D in both eyes.
•Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
•Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
•Has clear corneas and no active ocular disease.
•Has read, understood and signed the informed consent letter.

Exclusion Criteria

•Has a CL prescription outside the range of the available parameters of the study lenses.
•Has a spectacle cylinder less than -0.75D or more than -2.50D of cylinder in either eye.
•Slit lamp findings that would contraindicate contact lens wear such as:
•Pathological dry eye or associated findings
•Pterygium, pinguecula, or corneal scars within the visual axis
•Neovascularization \> 0.75 mm in form of the limbus
•Giant papillary conjuctivitis (GCP) worse than grade 1
•Anterior uveitis or iritis (past or present)
•Seborrheic eczema, seborrheic conjunctivitis
•History of corneal ulcers or fungal infections