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Clinical Evaluation of Two Daily Disposable Lenses in Neophytes

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ClinicalTrials.gov Identifier: NCT00987623
Recruitment Status : Completed
First Posted : October 1, 2009
Results First Posted : January 13, 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
Device: narafilcon A contact lens
Enrollment 326
Recruitment Details  
Pre-assignment Details Twenty-seven participants were enrolled but not dispensed. These participants were included in the Actual Enrollment calculation, but not in Participant Flow or Baseline Characteristics calculations.
Arm/Group Title Nelfilcon A Narafilcon A
Hide Arm/Group Description Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week. Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
Period Title: Overall Study
Started 145 154
Completed 140 151
Not Completed 5 3
Reason Not Completed
Lost to Follow-up             2             1
Time/job conflict             2             0
Discomfort             1             0
Biomicroscopy             0             1
Influenza             0             1
Arm/Group Title Nelfilcon A Narafilcon A Total
Hide Arm/Group Description Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week. Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week. Total of all reporting groups
Overall Number of Baseline Participants 145 154 299
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 145 participants 154 participants 299 participants
26.5  (9.8) 26.5  (10.5) 26.5  (10.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 154 participants 299 participants
Female
94
  64.8%
99
  64.3%
193
  64.5%
Male
51
  35.2%
55
  35.7%
106
  35.5%
1.Primary Outcome
Title Overall Lens Satisfaction
Hide Description Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week’s wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being Poor and 10 being Excellent
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis conducted per protocol, with exclusions due to major protocol deviations as determined by masked review, discontinuations, and/or missing responses.
Arm/Group Title Nelfilcon A Narafilcon A
Hide Arm/Group Description:
Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
Overall Number of Participants Analyzed 128 138
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
7.9  (1.7) 7.9  (1.6)
Time Frame Adverse event data were collected for the duration of the trial: 108 days.
Adverse Event Reporting Description This reporting group includes all enrolled and exposed participants.
 
Arm/Group Title Nelfilcon A Narafilcon A
Hide Arm/Group Description Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week. Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
All-Cause Mortality
Nelfilcon A Narafilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nelfilcon A Narafilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/151 (0.00%)   0/163 (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 Narafilcon A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/151 (0.00%)   0/163 (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: 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: NCT00987623     History of Changes
Other Study ID Numbers: P-337-C-031
First Submitted: September 29, 2009
First Posted: October 1, 2009
Results First Submitted: December 17, 2010
Results First Posted: January 13, 2011
Last Update Posted: July 10, 2012