A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks

NCT ID: NCT02345811

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-03-31

Brief Summary

To evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear.

Detailed Description

This was a randomized, bilateral, 2 week cross over, double-masked, dispensing study comparing Sapphire test lens against the senofilcon A control lens. This study results were not used to support design validation of the test lens.

Conditions

Myopia; Hyperopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sapphire

Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study.

Group Type: EXPERIMENTAL

Sapphire

Intervention Type: DEVICE

silicone-hydrogel contact lens

senofilcon A

Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study.

Group Type: ACTIVE_COMPARATOR

senofilcon A

Intervention Type: DEVICE

contact lens

Interventions

Sapphire

silicone-hydrogel contact lens

Intervention Type: DEVICE

senofilcon A

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 spectacle lens powers between -0.50 to -6.00 diopters sphere (0.25D steps) or +1.00 to +8.00 diopters sphere (1.00D steps)
• Has no more than 0.75 diopters of refractive astigmatism
• Willing to wear contact lens in both eyes
• 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 or planning a pregnancy at the time of enrolment (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 Lin, OD PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Lyndon Jones, PhD FCO

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo CCLR

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-15-01

Identifier Type: -

Identifier Source: org_study_id