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Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

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ClinicalTrials.gov Identifier: NCT01634659
Recruitment Status : Completed
First Posted : July 6, 2012
Results First Posted : November 28, 2013
Last Update Posted : December 24, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Myopia
Interventions Device: Delefilcon A contact lenses (DAILIES TOTAL1®)
Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)
Enrollment 330
Recruitment Details Participants were recruited from 18 study centers located in the US.
Pre-assignment Details Of the 330 participants enrolled, 17 were exited from the study prior to randomization and dispense of product.This reporting group includes all randomized and dispensed participants (313).
Arm/Group Title Delefilcon A, Then Narafilcon B Narafilcon B, Then Delefilcon A
Hide Arm/Group Description Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days. Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
Period Title: Period 1 - First 8 Days of Wear
Started 155 158
Completed 155 158
Not Completed 0 0
Period Title: Period 2 - Second 8 Days of Wear
Started 155 158
Completed 152 158
Not Completed 3 0
Reason Not Completed
Adverse Event             2             0
Physician Decision             1             0
Arm/Group Title Delefilcon A, Then Narafilcon B Narafilcon B, Then Delefilcon A Total
Hide Arm/Group Description Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days. Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days. Total of all reporting groups
Overall Number of Baseline Participants 155 158 313
Hide Baseline Analysis Population Description
This reporting group includes all randomized and dispensed participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 155 participants 158 participants 313 participants
31.9  (10.0) 32.1  (8.8) 32.0  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 158 participants 313 participants
Female
117
  75.5%
120
  75.9%
237
  75.7%
Male
38
  24.5%
38
  24.1%
76
  24.3%
1.Primary Outcome
Title Overall Comfort
Hide Description Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.
Arm/Group Title Delefilcon A Narafilcon B
Hide Arm/Group Description:
Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
Overall Number of Participants Analyzed 301 301
Mean (Standard Deviation)
Unit of Measure: Units on a scale
8.5  (1.7) 8.6  (1.5)
2.Secondary Outcome
Title Overall Quality of Vision
Hide Description Overall quality of vision was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall quality of vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.
Arm/Group Title Delefilcon A Narafilcon B
Hide Arm/Group Description:
Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
Overall Number of Participants Analyzed 301 301
Mean (Standard Deviation)
Unit of Measure: Units on a scale
8.6  (1.6) 8.5  (1.6)
3.Secondary Outcome
Title End of Day Comfort
Hide Description End of day comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. End of day comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.
Arm/Group Title Delefilcon A Narafilcon B
Hide Arm/Group Description:
Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
Overall Number of Participants Analyzed 301 301
Mean (Standard Deviation)
Unit of Measure: Units on a scale
7.7  (2.2) 7.9  (1.9)
Time Frame Adverse events were collected for the duration of the study (3 months).
Adverse Event Reporting Description An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the study medical device. This reporting group includes all randomized and dispensed participants.
 
Arm/Group Title Delefilcon A Narafilcon B
Hide Arm/Group Description Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2 Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
All-Cause Mortality
Delefilcon A Narafilcon B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Delefilcon A Narafilcon B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/313 (0.00%)   0/313 (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 Narafilcon B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/313 (0.00%)   0/313 (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: NCT01634659     History of Changes
Other Study ID Numbers: M-12-033
First Submitted: July 3, 2012
First Posted: July 6, 2012
Results First Submitted: September 27, 2013
Results First Posted: November 28, 2013
Last Update Posted: December 24, 2013