Proclear 1-D Multifocal Nondispensing Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01526902
First received: February 2, 2012
Last updated: March 7, 2014
Last verified: March 2014
Results First Received: November 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Presbyopia
Interventions: Device: omafilcon A / PC 1-D MF
Device: lotrafilcon B / Air Optix MF

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was open between 06FEB2012 and 28FEB2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The subjects who are current contact lens wearers should attend the first visit wearing their habitual lenses and having worn them that day for at least 2 hours prior to the visit.

Reporting Groups
  Description
Omafilcon A (PC 1-D MF) / Lotrafilcon B (AIR OPTIX MF) Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application).
Lotrafilcon B (AIR OPTIX MF) / Omafilcon A (PC 1-D MF) Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application).

Participant Flow:   Overall Study
    Omafilcon A (PC 1-D MF) / Lotrafilcon B (AIR OPTIX MF)     Lotrafilcon B (AIR OPTIX MF) / Omafilcon A (PC 1-D MF)  
STARTED     25     24  
COMPLETED     25     24  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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
Overall Study Population Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.

Baseline Measures
    Overall Study Population  
Number of Participants  
[units: participants]
  49  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     49  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  53  ± 6  
Gender  
[units: participants]
 
Female     39  
Male     10  
Region of Enrollment  
[units: participants]
 
United States     49  



  Outcome Measures
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1.  Primary:   Objective Vision Assessments: High Contrast Distance Visual Acuity   [ Time Frame: After 1 hour of lens wear ]

2.  Primary:   Objective Vision Assessments: High Contrast Intermediate Visual Acuity   [ Time Frame: After 1 hour of lens wear ]

3.  Primary:   Objective Vision Assessments: High Contrast Near Visual Acuity   [ Time Frame: After 1 hour of lens wear ]

4.  Secondary:   Subjective Overall Vision: High Contrast Distance Visual Quality   [ Time Frame: After 1 hour of lens wear ]

5.  Secondary:   Subjective Vision Assessments: High Contrast Intermediate Visual Quality   [ Time Frame: After 1 hour of lens wear ]

6.  Secondary:   Subjective Vision Assessments: High Contrast Near Visual Quality   [ Time Frame: After 1 hour of lens wear ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Pete Kollbaum, OD, PhD, FAAO, FBCLA, Principal Investigator
Organization: Indiana University
phone: 812-856-0108
e-mail: kollbaum@indiana.edu


No publications provided


Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01526902     History of Changes
Other Study ID Numbers: CV-12-02A
Study First Received: February 2, 2012
Results First Received: November 1, 2013
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board