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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716298
• Other study ID #: EX-MKTG-64
• Status: Completed
• Phase: N/A
• First received: March 17, 2016
• Last updated: September 23, 2016
• Start date: March 2016
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This is a 45 subject, 1-month dispensing, crossover, double-masked, randomized, bilateral study comparing the test lens against the control lens. Both test and control lenses will be used in a daily wear modality for 1 month each.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

• 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.

Exclusion Criteria:

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• fanfilcon A
contact lens
• lotrafilcon B
contact lens

Locations

Country	Name	City	State
Canada	Center for Contact Lens Research, University of Waterloo	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective comfort	Subjective ratings on comfort for fanfilcon A and lotrafilcon B lens. (Scale 0-10, 10=Can't feel the lenses, 0=Painful).	Up to 4 weeks	No
Primary	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)	Up to 4 weeks	No
Primary	Lens wettability	Lens wettability for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)	Up to 4 weeks	No
Primary	Surface deposits	Surface deposits for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)	Up to 4 weeks	No