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Clinical Evaluation of Stenfilcon A Soft Contact Lens When Compared to Ocufilcon B Soft Contact Lens

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ClinicalTrials.gov Identifier: NCT01354223
Recruitment Status : Completed
First Posted : May 16, 2011
Results First Posted : March 21, 2014
Last Update Posted : March 21, 2014
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: stenfilcon A contact lens
Device: ocufilcon B 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Ninety-three subjects evaluated, 3 subjects found to be ineligible and not randomized or dispensed. 90 adapted single-vision contact lens wearers with myopia were randomized and dispensed on a 2 to 1 ratio within each site and across entire study. Subjects used that same assigned product throughout study duration

Reporting Groups
  Description
Stenfilcon A Contact Lens Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
Ocufilcon B Contact Lens Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode

Participant Flow:   Overall Study
    Stenfilcon A Contact Lens   Ocufilcon B Contact Lens
STARTED   60   30 
COMPLETED   57   29 
NOT COMPLETED   3   1 
Withdrawal by Subject                3                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
Stenfilcon A Contact Lens Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
Ocufilcon B Contact Lens Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Total Total of all reporting groups

Baseline Measures
   Stenfilcon A Contact Lens   Ocufilcon B Contact Lens   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   30   90 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   60   30   90 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.6  (8.884)   29.8  (8.550)   31.7  (8.822) 
Gender 
[Units: Participants]
     
Female   38   21   59 
Male   22   9   31 
Region of Enrollment 
[Units: Participants]
     
United States   60   30   90 


  Outcome Measures

1.  Primary:   Objective Assessment: Ocular Response - Biomicroscopy   [ Time Frame: Change from baseline visit and all follow-ups visits ]

2.  Primary:   Comparison of Objective Findings - Number of Adverse Events in Unique Eyes   [ Time Frame: Any occurrence from dispensing to month 3 visit ]

3.  Primary:   Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better   [ Time Frame: week 1 visit, week 2 visit, month 1 visit, month 2 visit combined ]

4.  Secondary:   Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort   [ Time Frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 ]

5.  Secondary:   Evaluation of Average Lens Wearing Time - Average Daily Hours Worn   [ Time Frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3 ]


  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: William J. Gleason, O.D.
Organization: Foresight Regulatory Strategies, Inc.
phone: 978-658-6888 ext 151



Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01354223     History of Changes
Other Study ID Numbers: FC100239
First Submitted: January 10, 2011
First Posted: May 16, 2011
Results First Submitted: October 23, 2013
Results First Posted: March 21, 2014
Last Update Posted: March 21, 2014