Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism

NCT ID: NCT02410824

Last Updated: 2017-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-06-30

Brief Summary

Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.

Detailed Description

CooperVision is evaluating the clinical performance of an FDA cleared silicone-hydrogel lens material stenfilcon A (test) compared to etafilcon A for Astigmatism lens (control) when worn on a daily wear basis over one (1) week in a randomized, bilateral, cross-over, dispensing study.

Conditions

Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

stenfilcon A toric lens

Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.

Group Type: EXPERIMENTAL

stenfilcon A toric lens

Intervention Type: DEVICE

toric contact lens

etafilcon A toric lens

Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.

Group Type: ACTIVE_COMPARATOR

etafilcon A toric lens

Intervention Type: DEVICE

toric contact lens

Interventions

stenfilcon A toric lens

toric contact lens

Intervention Type: DEVICE

etafilcon A toric lens

toric contact lens

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer;
• Has read and signed an information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Is an adapted soft contact lens wearer;
• Requires a spherical contact lens prescription between -1.00 to -6.00 inclusive in each eye
• Has spectacle astigmatism: -0.50 to -1.50D (Diopter) cylinder (Axis: 90±20, 180±20 in both eyes);
• Willing to wear contact lens in both eyes for at least 8 hours per day, 7 days per week;
• Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye;
• To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable.

Exclusion Criteria

• Is participating in any concurrent clinical or research study;
• Has any known active* ocular disease and/or infection;
• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
• Is pregnant, lactating (by verbal confirmation at the screening visit);
• Is aphakic;
• Has undergone refractive error surgery

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meng C Lin, OD PhD

Role: PRINCIPAL_INVESTIGATOR

UC Berkeley Clinical Research Center

Locations

Clinical Research Center, University of California, Berkeley

Berkeley, California, United States

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada

Countries

United States; Canada

Other Identifiers

CV-15-02

Identifier Type: -

Identifier Source: org_study_id