A Bilateral Dispensing Comparison of Comfilcon A Over Senofilcon C Contact Lenses

NCT03684928 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-94
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the subjective acceptance of Comfilcon A contact lenses when worn on a daily wear modality over one month.

Conditions

Astigmatism Bilateral

Outcome Measures

Primary Outcomes (3)

• Ease of Insertion(Handling)

  Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)

  Baseline

• Ease of Insertion (Handling)

  Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)

  2 weeks

• Ease of Insertion(Handling)

  Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)

  1 month

Secondary Outcomes (2)

• Rotational Recovery After Lens Mislocation

  Baseline

• Rotational Recovery After Lens Mislocation

  1 month

Study Arms (2)

Comfilcon A (test)

ACTIVE COMPARATOR

Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study.

Device: Comfilcon A (test); Device: Senofilcon C (control)

Senofilcon C (control)

ACTIVE COMPARATOR

Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study.

Device: Comfilcon A (test); Device: Senofilcon C (control)

Interventions

Comfilcon A (test) DEVICE

Daily wear contact lenses

Comfilcon A (test); Senofilcon C (control)

Senofilcon C (control) DEVICE

Daily wear contact lenses

Comfilcon A (test); Senofilcon C (control)

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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:

• A person will be excluded from the study if he/she:
• 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 previous QUENA study.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

University Of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

Results Point of Contact

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

javega@coopervision.com

925 621 3761

Study Officials

• Lyndon Jones, PhD FCOptom

  Director, Centre for Ocular Research and 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

Model Details: Prospective, double-masked, bilateral, randomized, one month cross-over dispensing study.

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 26, 2018
• Study Start: July 23, 2018
• Primary Completion: December 14, 2018
• Study Completion: February 1, 2019
• Last Updated: June 26, 2020
• Results First Posted: June 26, 2020

Record last verified: 2019-04

Locations

CA (1)