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Tear Film Stability of DAILIES® AquaComfort Plus® Contact Lenses vs. MyDay® Daily Disposable Contact Lenses

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ClinicalTrials.gov Identifier: NCT02089191
Recruitment Status : Completed
First Posted : March 17, 2014
Results First Posted : May 15, 2015
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator)
Condition Refractive Error
Interventions Device: Nelfilcon A contact lenses
Device: Stenfilcon A contact lenses
Enrollment 31
Recruitment Details Subjects were recruited from 1 investigational site located in Germany.
Pre-assignment Details  
Arm/Group Title DACP/MyDay MyDay/DACP
Hide Arm/Group Description Nelfilcon A contact lenses worn in Period 1, followed by stenfilcon A contact lenses in Period 2 Stenfilcon A contact lenses worn in Period 1, followed by nelfilcon A contact lenses in Period 2
Period Title: Period 1, First 12 Hours
Started 16 15
Completed 16 15
Not Completed 0 0
Period Title: Period 2, Second 12 Hours
Started 15 [1] 15
Completed 15 15
Not Completed 0 0
[1]
One participant discontinued between Period 1 and Period 2 due to availability
Arm/Group Title Overall
Hide Arm/Group Description Nelfilcon A and stenfilcon A contact lenses worn for 12 hours each in Period 1 and 2 as randomized
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
This analysis group includes all enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
25.3  (3.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
22
  71.0%
Male
9
  29.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 31 participants
31
1.Primary Outcome
Title Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear
Hide Description The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The time to 15% destabilization of the tear film was calculated. A longer time indicates a more stable tear film. The right eye was evaluated.
Time Frame Day 1, Hour 12, each period
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan.
Arm/Group Title DACP MyDay
Hide Arm/Group Description:
Nelfilcon A contact lenses
Stenfilcon A contact lenses
Overall Number of Participants Analyzed 31 30
Mean (Standard Deviation)
Unit of Measure: seconds
22.84  (3.299) 22.87  (3.026)
2.Secondary Outcome
Title Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear
Hide Description The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The slope of the regression line (distorted areas vs. time) was calculated. A slower speed (higher number) indicates a more stable tear film. The right eye was evaluated.
Time Frame Hour 12
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan.
Arm/Group Title DACP MyDay
Hide Arm/Group Description:
Nelfilcon A contact lenses
Stenfilcon A contact lenses
Overall Number of Participants Analyzed 31 30
Mean (Standard Deviation)
Unit of Measure: percent distortion per second
0.3  (0.38) 0.2  (0.23)
Time Frame Adverse events were collected for the duration of the study (March 2014 to April 2014). This analysis population includes all participants/eyes exposed to any investigational product evaluated in this study.
Adverse Event Reporting Description An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign in subjects, users or other persons, whether or not related to the medical device.
 
Arm/Group Title DACP MyDay
Hide Arm/Group Description Nelfilcon A contact lenses Stenfilcon A contact lenses
All-Cause Mortality
DACP MyDay
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
DACP MyDay
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DACP MyDay
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/30 (0.00%) 
There was a high censoring rate observed with the objective measurements and therefore there are limitations to the conclusions that may be drawn.
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: Global Medical Affairs Brand Lead - Vision Care
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: NCT02089191    
Other Study ID Numbers: M-14-006
First Submitted: March 14, 2014
First Posted: March 17, 2014
Results First Submitted: April 30, 2015
Results First Posted: May 15, 2015
Last Update Posted: May 15, 2015