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

NCT03519932 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-91
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• Comfort at Insertion

  Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)

  Dispense

• Comfort

  Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)

  2 weeks

• Comfort

  Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)

  1-month

• Lens Preference Based on Overall Comfort

  Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)

  1 month

• Lens Preference Based on Overall Dryness

  Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)

  1 month

• Dryness

  Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)

  2 weeks

• Dryness

  Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)

  1-month

Secondary Outcomes (5)

• Ease of Insertion

  Dispense

• Ease of Insertion

  2-weeks

• Ease of Insertion

  1-month

• Ease of Removal

  2-weeks

• Ease of Removal

  1 month

Study Arms (2)

comfilcon A toric lens

EXPERIMENTAL

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

Device: comfilcon A toric lens; Device: samfilcon A toric lens

samfilcon A toric lens

ACTIVE COMPARATOR

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

Device: comfilcon A toric lens; Device: samfilcon A toric lens

Interventions

comfilcon A toric lens DEVICE

Contact lens

Also known as: Biofinity toric, test lens

comfilcon A toric lens; samfilcon A toric lens

samfilcon A toric lens DEVICE

Contact lens

Also known as: Ultra for Astigmatism, control lens

comfilcon A toric lens; samfilcon A toric lens

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A.Vega OD, MSc., FAAO
• Organization: CooperVision Inc.

javega@coopervision.com

9256213761

Study Officials

• Lyndon Jones, PhD FCOptom

  Director, Centre for Ocular Research & Education

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 9, 2018
• Study Start: April 30, 2018
• Primary Completion: October 15, 2018
• Study Completion: February 1, 2019
• Last Updated: January 6, 2020
• Results First Posted: January 6, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)