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ClinicalTrials.gov Identifier: NCT01097863
Recruitment Status : Completed
First Posted : April 2, 2010
Results First Posted : June 27, 2011
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Myopia
Interventions Device: nelfilcon A contact lens, modified inversion indicator
Device: nelfilcon A contact lens, no inversion indicator
Device: nelfilcon A contact lens, inversion indicator
Enrollment 280

Recruitment Details  
Pre-assignment Details This reporting group includes all enrolled and dispensed participants. Note: One subject was enrolled but not dispensed due to failing inclusion/exclusion criteria.
Arm/Group Title Nelfilcon A, Modified Inversion Indicator Nelfilcon A, No Inversion Indicator Nelfilcon A, Inversion Indicator
Hide Arm/Group Description nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
Period Title: Overall Study
Started 90 98 91
Completed 89 98 89
Not Completed 1 0 2
Reason Not Completed
Discomfort             1             0             1
Did not return for final visit             0             0             1
Arm/Group Title Nelfilcon A, Modified Inversion Indicator Nelfilcon A, No Inversion Indicator Nelfilcon A, Inversion Indicator Total
Hide Arm/Group Description nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week. Total of all reporting groups
Overall Number of Baseline Participants 90 98 91 279
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants 98 participants 91 participants 279 participants
36.2  (10.6) 33.3  (11.7) 34.1  (10.8) 34.5  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 98 participants 91 participants 279 participants
Female
52
  57.8%
69
  70.4%
69
  75.8%
190
  68.1%
Male
38
  42.2%
29
  29.6%
22
  24.2%
89
  31.9%
1.Primary Outcome
Title Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.
Hide Description As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, "Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion?" The positive "yes" responses are reported.
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis conducted per protocol, with exclusions due to protocol deviations as determined by masked review (9), and unavailable data due to discontinuations (3).
Arm/Group Title Nelfilcon A, Modified Inversion Indicator Nelfilcon A, No Inversion Indicator Nelfilcon A, Inversion Indicator
Hide Arm/Group Description:
nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
Overall Number of Participants Analyzed 86 97 84
Measure Type: Number
Unit of Measure: participants
77 15 84
Time Frame Adverse event data was collected for the duration of the trial: 78 days
Adverse Event Reporting Description This reporting group includes all enrolled and exposed participants: 280
 
Arm/Group Title Nelfilcon A, Modified Inversion Indicator Nelfilcon A, No Inversion Indicator Nelfilcon A, Inversion Indicator
Hide Arm/Group Description nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
All-Cause Mortality
Nelfilcon A, Modified Inversion Indicator Nelfilcon A, No Inversion Indicator Nelfilcon A, Inversion Indicator
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nelfilcon A, Modified Inversion Indicator Nelfilcon A, No Inversion Indicator Nelfilcon A, Inversion Indicator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/90 (0.00%)      0/98 (0.00%)      0/92 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nelfilcon A, Modified Inversion Indicator Nelfilcon A, No Inversion Indicator Nelfilcon A, Inversion Indicator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/90 (6.67%)      13/98 (13.27%)      13/92 (14.13%)    
Eye disorders       
Other contact lens symptoms not requiring treatment  [1]  6/90 (6.67%)  6 13/98 (13.27%)  13 13/92 (14.13%)  13
Indicates events were collected by systematic assessment
[1]
Participants reported on a questionnaire the nature, frequency and severity of any/all lens-related symptoms experienced with lens wear. Any frequency and/or severity significantly higher with study lenses than with habitual was an adverse event.
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 discussion, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.
Results Point of Contact
Name/Title: Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs
Organization: CIBA VISION
Phone: 1-800-241-7629
Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01097863     History of Changes
Other Study ID Numbers: P-346-C-010
First Submitted: March 31, 2010
First Posted: April 2, 2010
Results First Submitted: May 27, 2011
Results First Posted: June 27, 2011
Last Update Posted: July 10, 2012