A Dispensing Clinical of Fanfilcon A Lens Against Lotrafilcon B Lens Over 1 Month Wear Per Lens

NCT02716298 | Completed Results

• 1 other identifier: EX-MKTG-64
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to evaluate the performance of fanfilcon A lens when worn on a daily wear modality over approximately 1 month in comparison to the lotrafilcon B lens.

Conditions

Myopia

Outcome Measures

Primary Outcomes (4)

• Subjective Comfort

  Subjective ratings on comfort at insertion (at baseline), comfort when lenses are first put in, comfort during the day's wear, and comfort prior to lens removal (1 month) for fanfilcon A and lotrafilcon B lens. (Scale 0-10, 10=Can't feel the lenses, 0=Painful).

  Baseline, 1 month

• Subjective Preference

  Subjective ratings on preference for fanfilcon A and lotrafilcon B lens. (Strongly prefer fanfilcon A, slightly prefer fanfilcon A, no preference, slightly prefer lotrafilcon B, strongly prefer lotrafilcon B). Subject preference in terms of comfort, dryness, clear vision, Lens Handling, digital devices, all day natural comfort, All day comfort, same comfort at the end of the day (EOD), comfortable after the end of 4 weeks, Same comfort at 4 weeks as initial, comfortable in dry environments, help focus effortlessly while using digital devices, help with end of day (EOD) dryness, help eyes feel less tired at EOD (including computer or digital device use), offering clear vision during driving.

  1 month

• Lens Wettability

  Lens wettability for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)

  Baseline, 1 month

• Surface Deposits

  Surface deposits for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)

  Baseline, 1 month

Study Arms (2)

fanfilcon A

ACTIVE COMPARATOR

Study participants are randomized to wear fanfilcon A lens during the crossover study

Device: fanfilcon A

lotrafilcon B

ACTIVE COMPARATOR

Study participants are randomized to wear lotrafilcon B lens during the crossover study.

Device: lotrafilcon B

Interventions

fanfilcon A DEVICE

contact lens

fanfilcon A

lotrafilcon B DEVICE

contact lens

lotrafilcon B

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 read and signed an information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
• Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day);
• Demonstrates an acceptable fit with the study lenses.

You may not qualify if:

• A person will be excluded from the study if he/she:
• Is participating in any concurrent clinical or research study;
• Is a habitual wearer of lotrafilcon B or enfilcon A lenses.
• 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 enrollment; (by verbal confirmation at the Screening Visit)
• Is aphakic;
• Has undergone refractive error surgery;
• For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Senior Manager Global Medical Scientific Affairs
• Organization: CooperVision

javega@coopervision.com

925-621-3761

Study Officials

• Lyndon Jones

  Director, Centre for Contact Lens Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: March 17, 2016
• First Posted: March 23, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 30, 2017
• Results First Posted: March 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)