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A Prospective Study of Two Daily Disposable Contact Lenses

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ClinicalTrials.gov Identifier: NCT01636986
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : January 14, 2014
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Myopia
Interventions Device: Delefilcon A contact lenses
Device: Etafilcon A contact lenses
Enrollment 62
Recruitment Details Participants were recruited from 1 US study center.
Pre-assignment Details This reporting group includes all enrolled and randomized participants.
Arm/Group Title DAILIES TOTAL1 1DAVM
Hide Arm/Group Description Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
Period Title: Overall Study
Started 30 32
Completed 30 30
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             1
Corneal Staining             0             1
Arm/Group Title DAILIES TOTAL1 1DAVM Total
Hide Arm/Group Description Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
This reporting group includes all enrolled and randomized participants who completed the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
23.26  (4.28) 24.53  (4.83) 23.89  (4.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
23
  76.7%
24
  80.0%
47
  78.3%
Male
7
  23.3%
6
  20.0%
13
  21.7%
1.Primary Outcome
Title Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
Hide Description Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom.
Time Frame Day 0, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and randomized participants who completed the study.
Arm/Group Title DAILIES TOTAL1 1DAVM
Hide Arm/Group Description:
Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Eyes feel uncomfortable -0.21  (0.13) -0.17  (0.16)
Eyes feel dry -1.07  (0.68) -0.92  (0.90)
Vision change between clear and blurry -0.04  (0.04) -0.04  (0.04)
Eyes feel irritated -0.42  (0.32) -0.31  (0.28)
Eyes feel gritty and scratchy -0.10  (0.10) -0.07  (0.07)
Feel "something" in the eye -0.47  (0.58) -0.38  (0.54)
Eyes burning and stinging -0.25  (0.34) -0.28  (0.36)
Eyes feel unusually sensitive to bright light -0.23  (0.35) -0.19  (0.32)
Eyes itch -0.43  (0.41) -0.38  (0.46)
Time Frame Adverse events were collected for the duration of the study (4 months).
Adverse Event Reporting Description This reporting group includes all enrolled participants who were exposed to the test product.
 
Arm/Group Title DAILIES TOTAL1 1DAVM
Hide Arm/Group Description Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
All-Cause Mortality
DAILIES TOTAL1 1DAVM
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DAILIES TOTAL1 1DAVM
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DAILIES TOTAL1 1DAVM
Affected / at Risk (%) Affected / at Risk (%)
Total   7/30 (23.33%)   8/32 (25.00%) 
Eye disorders     
Contact lens fell out  0/30 (0.00%)  2/32 (6.25%) 
Eye irritation  4/30 (13.33%)  4/32 (12.50%) 
Corneal Staining  1/30 (3.33%)  2/32 (6.25%) 
Foreign body sensation  2/30 (6.67%)  0/32 (0.00%) 
The study was not powered to detect differences in individual items.
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, PhD
Organization: Alcon Research, Ltd.
Phone: 1-888-452-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01636986     History of Changes
Other Study ID Numbers: A00930
First Submitted: July 6, 2012
First Posted: July 10, 2012
Results First Submitted: November 25, 2013
Results First Posted: January 14, 2014
Last Update Posted: January 14, 2014