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Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers

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: NCT01614600
Recruitment Status : Completed
First Posted : June 8, 2012
Results First Posted : December 4, 2013
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Dry Eye Syndrome
Myopia
Intervention Device: Nelfilcon A contact lenses
Enrollment 88
Recruitment Details Participants were recruited from 8 study centers located in the United States.
Pre-assignment Details Of the 91 participants enrolled, 3 were exited as screen failures prior to dispensing of the study product. This reporting group includes all enrolled and dispensed participants.
Arm/Group Title DAILIES® AquaComfort Plus®
Hide Arm/Group Description Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
Period Title: Overall Study
Started 88
Completed 84
Not Completed 4
Reason Not Completed
Unacceptable fit             1
Discomfort             1
Unable to remove lens at the end of day             1
Protocol deviation             1
Arm/Group Title DAILIES® AquaComfort Plus®
Hide Arm/Group Description Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
Overall Number of Baseline Participants 88
Hide Baseline Analysis Population Description
This reporting group includes all enrolled and dispensed participants.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants
32.2  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
Female
66
  75.0%
Male
22
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 88 participants
88
1.Primary Outcome
Title Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2
Hide Description Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye.
Time Frame Baseline, Week 1, Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol: All enrolled and dispensed participants, minus any major protocol deviators as determined by masked review.
Arm/Group Title DAILIES® AquaComfort Plus®
Hide Arm/Group Description:
Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
Overall Number of Participants Analyzed 74
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change from Baseline at Week 1 -0.09  (1.24)
Change from Baseline at Week 2 -0.29  (1.06)
Time Frame Adverse events were collected for the duration of the study (3 months).
Adverse Event Reporting Description This reporting group includes all enrolled and dispensed participants.
 
Arm/Group Title DAILIES® AquaComfort Plus®
Hide Arm/Group Description Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
All-Cause Mortality
DAILIES® AquaComfort Plus®
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
DAILIES® AquaComfort Plus®
Affected / at Risk (%)
Total   0/88 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DAILIES® AquaComfort Plus®
Affected / at Risk (%)
Total   0/88 (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: Jami Kern, MBA, 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: NCT01614600    
Other Study ID Numbers: A00849
First Submitted: June 6, 2012
First Posted: June 8, 2012
Results First Submitted: September 27, 2013
Results First Posted: December 4, 2013
Last Update Posted: December 4, 2013