A Dispensing Clinical of Fanfilcon A Lens Against Lotrafilcon B Lens Over 1 Month Wear Per Lens
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02716298|
Recruitment Status : Completed
First Posted : March 23, 2016
Results First Posted : March 21, 2017
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myopia||Device: fanfilcon A Device: lotrafilcon B||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Dispensing Clinical of Fanfilcon A Lens Against Lotrafilcon B Lens Over 1 Month Wear Per Lens|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||August 2016|
Active Comparator: fanfilcon A
Study participants are randomized to wear fanfilcon A lens during the crossover study
Device: fanfilcon A
Active Comparator: lotrafilcon B
Study participants are randomized to wear lotrafilcon B lens during the crossover study.
Device: lotrafilcon B
- Subjective Comfort [ Time Frame: Baseline, 1 month ]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).
- Subjective Preference [ Time Frame: 1 month ]
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.
- Lens Wettability [ Time Frame: Baseline, 1 month ]Lens wettability for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)
- Surface Deposits [ Time Frame: Baseline, 1 month ]Surface deposits for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716298
|Center for Contact Lens Research, University of Waterloo|
|Waterloo, Ontario, Canada, N2L 3G1|
|Principal Investigator:||Lyndon Jones||Director, Centre for Contact Lens Research|