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Product Performance of a Toric Contact Lens

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ClinicalTrials.gov Identifier: NCT00658996
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : February 16, 2011
Last Update Posted : December 12, 2011
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Myopia
Astigmatism
Interventions: Device: SofLens DD Toric
Device: Ciba Vision Focus Dailies Toric 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
This 4-week study was conducted at 12 sites in Asia. First participant enrolled 4/16/08, last participant visit was 6/20/08

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
220 participants were enrolled in the study, 4 participants were ineligible at screening visit, 216 Subjects started the first intervention. 211 participants started the second intervention. 209 participants completed the study.

Reporting Groups
  Description
SofLens DD Toric First, Then Focus Dailies Toric Bausch & Lomb SofLens Daily Disposable Toric Contact Lens first then crossover to Ciba Vision Focus Dailies Toric Lens
Focus Dailies Toric First, Then SofLens DD Toric Ciba Vision Focus Dailies Toric Lens first, then crossover to Bausch & Lomb SofLens Daily Disposable Toric Contact Lens

Participant Flow for 3 periods

Period 1:   First Intervention
    SofLens DD Toric First, Then Focus Dailies Toric   Focus Dailies Toric First, Then SofLens DD Toric
STARTED   109   107 
COMPLETED   108   106 
NOT COMPLETED   1   1 
Positive slit lamp finding                1                0 
Lack of lenses                0                1 

Period 2:   Crossover Period
    SofLens DD Toric First, Then Focus Dailies Toric   Focus Dailies Toric First, Then SofLens DD Toric
STARTED   108   106 
COMPLETED   106   105 
NOT COMPLETED   2   1 
Physician Decision                1                0 
Ineligible                1                1 

Period 3:   Second Intervention
    SofLens DD Toric First, Then Focus Dailies Toric   Focus Dailies Toric First, Then SofLens DD Toric
STARTED   106   105 
COMPLETED   105   104 
NOT COMPLETED   1   1 
Developed a stye on upper lid                1                0 
Positive slit lamp finding                0                1 



  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
Entire Study Population Population enrolled at start of study

Baseline Measures
   Entire Study Population 
Overall Participants Analyzed 
[Units: Participants]
 216 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.7  (7.19) 
Gender 
[Units: Participants]
 
Female   150 
Male   66 
Race/Ethnicity, Customized 
[Units: Participants]
 
Asian   216 
White   0 
Black   0 
Other   0 


  Outcome Measures

1.  Primary:   Symptoms and Complaints   [ Time Frame: Over-all follow-up visits for 2 week period ]

2.  Primary:   Contact Lens High Contrast Visual Acuity   [ Time Frame: Over-all follow-up visits, 2 weeks ]

3.  Secondary:   Slit Lamp Findings   [ Time Frame: Over-all follow-up visits, 2 weeks ]


  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: Gerard Cairns, PhD, MCOptom
Organization: Bausch & Lomb Incorporated
phone: (585) 338-5170
e-mail: gerard.cairns@bausch.com



Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00658996     History of Changes
Other Study ID Numbers: 559
First Submitted: April 12, 2008
First Posted: April 16, 2008
Results First Submitted: December 14, 2010
Results First Posted: February 16, 2011
Last Update Posted: December 12, 2011