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Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact 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: NCT01561560
Recruitment Status : Completed
First Posted : March 23, 2012
Results First Posted : January 7, 2014
Last Update Posted : January 7, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Myopia
Interventions Device: Delefilcon A contact lenses
Device: Narafilcon A contact lenses
Enrollment 123
Recruitment Details Participants were recruited from two study centers in Finland, three study centers in German, and three study centers in the UK.
Pre-assignment Details Of the 123 participants enrolled, two were excluded prior to randomization. This reporting group includes all participants enrolled and exposed to Test Article (121).
Arm/Group Title DAILIES TOTAL1, Then TRUEYE TRUEYE, Then DAILIES TOTAL1
Hide Arm/Group Description Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks. Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
Period Title: First Two Weeks of Wear
Started 60 61
Completed 60 59
Not Completed 0 2
Reason Not Completed
Time/job conflict             0             1
Adverse Event             0             1
Period Title: Second Two Weeks of Wear
Started 60 59
Completed 60 58
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Arm/Group Title OVERALL
Hide Arm/Group Description Delefilcon A contact lenses and narafilcon A contact lenses worn in randomized order. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
Overall Number of Baseline Participants 121
Hide Baseline Analysis Population Description
All participants enrolled and exposed to Test Article
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants
34.0  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants
Female
85
  70.2%
Male
36
  29.8%
1.Primary Outcome
Title End-of-day Comfort
Hide Description End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all participants who finished the study, minus any major protocol deviations as determined by masked review.
Arm/Group Title DAILIES TOTAL1 TRUEYE
Hide Arm/Group Description:
Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
Overall Number of Participants Analyzed 116 116
Mean (Standard Deviation)
Unit of Measure: Units on a scale
8.3  (1.91) 6.6  (2.22)
Time Frame Adverse events were collected for the duration of the study. The safety population includes all participants enrolled and exposed to Test Article.
Adverse Event Reporting Description An adverse event was defined as an event that caused, or had the potential to cause, unexpected or unwanted effects involving the safety of device users (including patients) or other persons.
 
Arm/Group Title DAILIES TOTAL1 TRUEYE
Hide Arm/Group Description Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
All-Cause Mortality
DAILIES TOTAL1 TRUEYE
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
DAILIES TOTAL1 TRUEYE
Affected / at Risk (%) Affected / at Risk (%)
Total   0/119 (0.00%)   0/121 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DAILIES TOTAL1 TRUEYE
Affected / at Risk (%) Affected / at Risk (%)
Total   0/119 (0.00%)   0/121 (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.
Study data should not be disclosed to any third party for a period of three years after the termination of the study without prior written consent.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jami Kern, PhD
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01561560    
Other Study ID Numbers: P-347-C-019
First Submitted: March 21, 2012
First Posted: March 23, 2012
Results First Submitted: November 19, 2013
Results First Posted: January 7, 2014
Last Update Posted: January 7, 2014