Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses

NCT ID: NCT03519932

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2019-02-01

Brief Summary

The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.

Conditions

Astigmatism

Study Design

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

Study Groups

comfilcon A toric lens

Subjects who wear comfilcon A toric lens either as first or second pair during this cross-over study.

Group Type: EXPERIMENTAL

comfilcon A toric lens

Intervention Type: DEVICE

Contact lens

samfilcon A toric lens

Intervention Type: DEVICE

Contact lens

samfilcon A toric lens

Subjects who wear samfilcon A toric lens either as first or second pair during this cross-over study.

Group Type: ACTIVE_COMPARATOR

comfilcon A toric lens

Intervention Type: DEVICE

Contact lens

samfilcon A toric lens

Intervention Type: DEVICE

Contact lens

Interventions

comfilcon A toric lens

Contact lens

Intervention Type: DEVICE

samfilcon A toric lens

Contact lens

Intervention Type: DEVICE

Other Intervention Names

Biofinity toric; test lens; Ultra for Astigmatism; control lens

Eligibility Criteria

Inclusion Criteria

• Is at least 17 years of age and has full legal capacity to volunteer;
• Has had a self-reported oculo-visual examination in the last two years.
• 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, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
• Is willing to wear contact lens in both eyes for the duration of the study;
• Has a minimum astigmatism of - 0.75, determined by refraction;
• Can be fit with the two study contact lens types in the powers available;
• Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
• Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
• Has clear corneas and no active* ocular disease

Exclusion Criteria

• Is participating in any concurrent clinical trial;
• Has any known active* ocular disease and/or infection;
• Has a systemic condition that in the opinion of the investigator may affect a study measure;
• Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
• Has known sensitivity to fluorescein dye or products to be used in the study;
• Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
• 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.
• Has participated in the PIANO (i.e. EX-MKTG-83) Study.

• 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

Lyndon Jones, PhD FCOptom

Role: PRINCIPAL_INVESTIGATOR

Director, Centre for Ocular Research & Education

Locations

University of Waterloo

Waterloo, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EX-MKTG-91

Identifier Type: -

Identifier Source: org_study_id