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Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses

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ClinicalTrials.gov Identifier: NCT01362907
Recruitment Status : Completed
First Posted : June 1, 2011
Results First Posted : August 3, 2012
Last Update Posted : August 3, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

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 lens
Device: Etafilcon A contact lens
Enrollment 40
Recruitment Details Participants were recruited from 4 US private practices.
Pre-assignment Details  
Arm/Group Title Delefilcon A / Etafilcon A Etafilcon A / Delefilcon A
Hide Arm/Group Description Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Period Title: Period 1, One Week
Started 20 20
Completed 20 20
Not Completed 0 0
Period Title: Period 2, One Week
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Overall
Hide Arm/Group Description All enrolled participants
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
32.7  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
29
  72.5%
Male
11
  27.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)
Hide Description As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.
Time Frame 1 week of wear, replacing lenses daily
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled and dispensed participants.
Arm/Group Title Delefilcon A Etafilcon A
Hide Arm/Group Description:
Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Overall Number of Participants Analyzed 40 40
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
80 80
Mean (Standard Deviation)
Unit of Measure: logMAR
-0.02  (0.06) -0.02  (0.05)
2.Primary Outcome
Title Overall Comfort
Hide Description As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame 1 week of wear, replacing lenses daily
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled and dispensed participants.
Arm/Group Title Delefilcon A Etafilcon A
Hide Arm/Group Description:
Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: Units on a scale
9.0  (1.5) 8.1  (1.6)
3.Primary Outcome
Title Overall Vision Quality
Hide Description As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame 1 week of wear, replacing lenses daily
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled and dispensed participants.
Arm/Group Title Delefilcon A Etafilcon A
Hide Arm/Group Description:
Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: Units on a scale
9.4  (1.0) 8.9  (1.2)
4.Primary Outcome
Title Overall Handling
Hide Description As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.
Time Frame 1 week of wear, replacing lenses daily
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled and dispensed participants.
Arm/Group Title Delefilcon A Etafilcon A
Hide Arm/Group Description:
Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: Units on a scale
8.5  (1.9) 8.6  (1.4)
5.Secondary Outcome
Title Overall Lens Fit
Hide Description As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight.
Time Frame 1 week of wear, replacing lenses daily
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled and dispensed participants.
Arm/Group Title Delefilcon A Etafilcon A
Hide Arm/Group Description:
Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Overall Number of Participants Analyzed 40 40
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
80 80
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.1  (0.5) 0.1  (0.3)
Time Frame Adverse events were collected for the duration of the trial: 1 month.
Adverse Event Reporting Description The safely population included all enrolled and exposed participants.
 
Arm/Group Title Delefilcon A Etafilcon A
Hide Arm/Group Description Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week. Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
All-Cause Mortality
Delefilcon A Etafilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Delefilcon A Etafilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Delefilcon A Etafilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (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.
For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.
Results Point of Contact
Name/Title: Joachim Nick, Dipl. Ing. (FH)
Organization: Alcon Research
Phone: +49 6022 240 520
Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01362907     History of Changes
Other Study ID Numbers: P-347-C-013
First Submitted: May 27, 2011
First Posted: June 1, 2011
Results First Submitted: June 28, 2012
Results First Posted: August 3, 2012
Last Update Posted: August 3, 2012