Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Two Marketed Silicone Hydrogel Lenses

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: NCT02495948
Recruitment Status : Completed
First Posted : July 13, 2015
Results First Posted : October 19, 2016
Last Update Posted : December 28, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant)
Condition Refractive Error
Interventions Device: Lotrafilcon B contact lenses
Device: Samfilcon A contact lenses
Device: Hydrogen peroxide solution
Device: Saline solution
Enrollment 168
Recruitment Details Participants were recruited from 10 investigational sites located in the US.
Pre-assignment Details Of the 168 enrolled, 1 participant was exited as a screen failure prior to randomization. This reporting group includes all randomized participants (167).
Arm/Group Title AOA Then ULTRA ULTRA Then AOA
Hide Arm/Group Description Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality. Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
Period Title: Period 1, First 30 Days of Wear
Started 83 84
Completed 83 83
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Period Title: Period 2, Second 30 Days of Wear
Started 83 83
Completed 82 82
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title Overall
Hide Arm/Group Description Lotrafilcon B and samfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
Overall Number of Baseline Participants 167
Hide Baseline Analysis Population Description
This analysis population includes all randomized participants (Intent-to-Treat (ITT) analysis set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 167 participants
31.9  (9.01)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants
Female
130
  77.8%
Male
37
  22.2%
1.Primary Outcome
Title Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear
Hide Description The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error.
Time Frame Day 30, each product
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat analysis set
Arm/Group Title AIR OPTIX AQUA (AOA) ULTRA
Hide Arm/Group Description:
Lotrafilcon B contact lenses worn during Period 1 or Period 2 for 30 days
Samfilcon A contact lenses worn during Period 1 or Period 2 for 30 days
Overall Number of Participants Analyzed 167 167
Overall Number of Units Analyzed
Type of Units Analyzed: Lenses
34 33
Mean (Standard Deviation)
Unit of Measure: micrograms
1.63  (2.21) 4.89  (3.12)
Time Frame Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (at least 62 days). AEs are reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device.
 
Arm/Group Title Pretreatment AIR OPTIX AQUA ULTRA
Hide Arm/Group Description All subjects who consented to participate in the study prior to the initiation of study treatment All subjects exposed to lotrafilcon B contact lenses during Period 1 or Period 2 All subjects exposed to samfilcon A contact lenses during Period 1 or Period 2
All-Cause Mortality
Pretreatment AIR OPTIX AQUA ULTRA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Pretreatment AIR OPTIX AQUA ULTRA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/168 (0.00%)   0/166 (0.00%)   0/167 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pretreatment AIR OPTIX AQUA ULTRA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/168 (0.00%)   0/166 (0.00%)   0/167 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Affairs Brand Lead, Vision Care
Organization: Alcon, A Novartis Division
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02495948    
Other Study ID Numbers: CLA560-P001
First Submitted: July 9, 2015
First Posted: July 13, 2015
Results First Submitted: August 25, 2016
Results First Posted: October 19, 2016
Last Update Posted: December 28, 2016