ClinicalTrials.gov
ClinicalTrials.gov Menu

Short-Term Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01240122
Recruitment Status : Completed
First Posted : November 15, 2010
Results First Posted : June 11, 2012
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Other
Condition: Corneal Staining
Interventions: Device: Biotrue MPS
Device: Investigational MPS

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Biotrue/Investigational MPS Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.

Participant Flow:   Overall Study
    Biotrue/Investigational MPS
STARTED   29 
COMPLETED   29 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Biotrue/Investigational MPS Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.

Baseline Measures
   Biotrue/Investigational MPS 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age, Customized 
[Units: Participants]
 
<18 years   0 
18 years of age or older   29 
Sex/Gender, Customized [1] 
[Units: Participants]
 
Male   0 
Female   0 
Unknown   29 
[1] Gender was not an analysis endpoint for this study.


  Outcome Measures

1.  Primary:   Corneal Staining by Wear Time   [ Time Frame: 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4 ]

2.  Secondary:   Subjective Solution Preference   [ Time Frame: Day 4 ]

3.  Secondary:   Overall Ocular Comfort   [ Time Frame: Day 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Manager, Clinical Research
Organization: Abbott Medical Optics
phone: 714.247.8723
e-mail: eugenia.kao@amo.abbott.com



Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01240122     History of Changes
Other Study ID Numbers: COBR-109-9608
First Submitted: November 8, 2010
First Posted: November 15, 2010
Results First Submitted: February 15, 2012
Results First Posted: June 11, 2012
Last Update Posted: February 6, 2018