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Trial record 20 of 328 for:    contact lens | Studies With Results

A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens

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ClinicalTrials.gov Identifier: NCT01130974
Recruitment Status : Completed
First Posted : May 26, 2010
Results First Posted : December 10, 2013
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: Bausch & Lomb contact lens
Device: Marketed daily disposable contact lens

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
200 Asian participants (400 eyes) who were adapted wearers of soft contact lenses were enrolled in this 1-month study at approximately 10 investigative sites in Asia and the United States. First participant was enrolled 4/12/2010 and last participant exited the study 08/09/2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 200 participants (400 eyes) enrolled and dispensed lenses, 172 participants (344 eyes) completed the study

Reporting Groups
  Description
Bausch & Lomb Contact Lens Bausch & Lomb daily disposable cosmetic tint contact lens
Marketed Daily Disposable Contact Lens Marketed daily disposable cosmetic tint contact lens

Participant Flow:   Overall Study
    Bausch & Lomb Contact Lens   Marketed Daily Disposable Contact Lens
STARTED   100   100 
COMPLETED   85   87 
NOT COMPLETED   15   13 
Protocol Violation                10                10 
Withdrawal by Subject                0                1 
Ineligibility criteria                5                2 



  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.
All participants were randomized and dispensed lenses at the baseline visit.

Reporting Groups
  Description
Bausch & Lomb Contact Lens Bausch & Lomb daily disposable cosmetic tint contact lens
Marketed Daily Disposable Contact Lens Marketed daily disposable cosmetic tint contact lens
Total Total of all reporting groups

Baseline Measures
   Bausch & Lomb Contact Lens   Marketed Daily Disposable Contact Lens   Total 
Overall Participants Analyzed 
[Units: Participants]
 100   100   200 
Age, Customized 
[Units: Participants]
     
Between 18 and 62 years   100   100   200 
Gender 
[Units: Participants]
     
Female   74   76   150 
Male   26   24   50 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian Decent   100   100   200 


  Outcome Measures

1.  Primary:   Slit Lamp Findings   [ Time Frame: Summarized over all follow-up visits through 1 month ]

2.  Primary:   logMAR Visual Acuity (VA)   [ Time Frame: Summarized over all visits, and dispensed visit ]

3.  Primary:   logMAR Visual Acuity (VA)   [ Time Frame: 2 week and 1 month follow-up ]

4.  Secondary:   Lens Wettability   [ Time Frame: Summarized over all follow-up visits through 1 month ]

5.  Secondary:   Lens Deposits   [ Time Frame: Summarized over all follow-up visits through one month ]

6.  Secondary:   Lens Centration   [ Time Frame: Summarized over all follow-up visits through 1 month ]

7.  Secondary:   Lens Movement   [ Time Frame: Summarized over all follow-up visits through one month ]

8.  Secondary:   Symptoms & Complaints   [ Time Frame: Summarized over all follow-up visits through one month ]


  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:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Robert Steffen
Organization: Bausch & Lomb Inc.
phone: (585) 338-6399
e-mail: robert.steffens@bausch.com



Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01130974     History of Changes
Other Study ID Numbers: 639
First Submitted: May 25, 2010
First Posted: May 26, 2010
Results First Submitted: March 15, 2013
Results First Posted: December 10, 2013
Last Update Posted: December 10, 2013