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Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

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ClinicalTrials.gov Identifier: NCT00933166
Recruitment Status : Completed
First Posted : July 7, 2009
Results First Posted : December 23, 2010
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Myopia
Intervention Device: Lotrafilcon A contact lens
Enrollment 169
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lotrafilcon A
Hide Arm/Group Description Investigational contact lens worn in both eyes for three months
Period Title: Overall Study
Started 169
Completed 151
Not Completed 18
Reason Not Completed
Lost to Follow-up             4
Lack of Efficacy             9
Unavailable             4
Withdrawal by Subject             1
Arm/Group Title Lotrafilcon A
Hide Arm/Group Description Investigational contact lens worn in both eyes for three months
Overall Number of Baseline Participants 169
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 169 participants
37.3  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 169 participants
Female
115
  68.0%
Male
54
  32.0%
1.Primary Outcome
Title Comfort After Insertion
Hide Description Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol and excluded ten major protocol deviations as determined by masked review. Eighteen participants discontinued prior to the Month 3 visit. Nineteen participants responded N/A due to reasons such as continual wear.
Arm/Group Title Lotrafilcon A
Hide Arm/Group Description:
Investigational contact lens worn in both eyes for three months
Overall Number of Participants Analyzed 122
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
9.0  (1.6)
Time Frame Adverse event data were collected for the duration of the trial: 4 months, 16 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lotrafilcon A
Hide Arm/Group Description Investigational contact lens worn in both eyes for three months
All-Cause Mortality
Lotrafilcon A
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lotrafilcon A
Affected / at Risk (%)
Total   0/169 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lotrafilcon A
Affected / at Risk (%)
Total   0/169 (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: NCT00933166     History of Changes
Other Study ID Numbers: P-335-C-014v2
First Submitted: July 2, 2009
First Posted: July 7, 2009
Results First Submitted: December 2, 2010
Results First Posted: December 23, 2010
Last Update Posted: July 10, 2012