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Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses

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ClinicalTrials.gov Identifier: NCT01548833
Recruitment Status : Completed
First Posted : March 8, 2012
Results First Posted : June 24, 2013
Last Update Posted : June 24, 2013
Sponsor:
Collaborator:
Aston University
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Myopia
Interventions Device: Delefilcon A contact lens
Device: Narafilcon A contact lens
Device: Filcon II 3 contact lens
Enrollment 39
Recruitment Details Participants were recruited from one study center in the United Kingdom.
Pre-assignment Details This reporting group includes all enrolled participants.
Arm/Group Title Overall
Hide Arm/Group Description All enrolled participants
Period Title: Overall Study
Started 39
Completed 39
Not Completed 0
Arm/Group Title Overall
Hide Arm/Group Description DT1, TruEye, and Clariti contact lenses worn in randomized, cross-over fashion for one week each
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
All enrolled participants
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants
22.1  (3.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
21
  53.8%
Male
18
  46.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 39 participants
39
1.Primary Outcome
Title Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)
Hide Description The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time.
Time Frame Day 7, 16 hours after lens insertion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dailies Total 1 TruEye Clariti
Hide Arm/Group Description:
Delefilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
Narafilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
Filcon II 3 contact lenses worn for one week in a daily wear, daily disposable manner.
Overall Number of Participants Analyzed 39 39 39
Mean (Standard Deviation)
Unit of Measure: seconds
13.56  (3.7759121) 12.0  (2.9676727) 11.86  (3.5982819)
Time Frame Adverse events were collected for the duration of the trial.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dailies Total 1 TruEye Clariti
Hide Arm/Group Description Delefilcon A contact lenses worn for one week in a daily wear, daily disposable manner. Narafilcon A contact lenses worn for one week in a daily wear, daily disposable manner. Filcon II 3 contact lenses worn for one week in a daily wear, daily disposable manner.
All-Cause Mortality
Dailies Total 1 TruEye Clariti
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dailies Total 1 TruEye Clariti
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/39 (0.00%)   0/39 (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 Total 1 TruEye Clariti
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/39 (0.00%)   0/39 (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
Name/Title: Jami Kern, PhD
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01548833     History of Changes
Other Study ID Numbers: A00924
First Submitted: March 6, 2012
First Posted: March 8, 2012
Results First Submitted: April 22, 2013
Results First Posted: June 24, 2013
Last Update Posted: June 24, 2013