Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients

This study has been completed.
Sponsor:
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01016652
First received: November 18, 2009
Last updated: January 22, 2014
Last verified: January 2014
Results First Received: September 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Presbyopia
Interventions: Device: etafilcon A multifocal contact lens
Device: etafilcon A Contact Lens

  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
This was a four week, 49 subject, doubly-masked, daily wear, two-part crossover study. Recruited patients were emerging presbyopic (35-47 years) and soft CL wearing who were experiencing any near vision symptoms.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A screening questionnaire (Near Vision Questionnaire, (NVQ)) was used to recruit subjects and to provide information about the wider population.

Reporting Groups
  Description
Etafilcon A Multifocal/ Etafilcon A Sphere etafilcon A multifocal/ etafilcon A sphere Arm: The first test lens for this arm, etafilcon A multifocal, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted. Repeat for the second lens (sphere).
Etafilcon A Sphere/ Etafilcon A Multifocal

etafilcon A sphere/ etafilcon A multifocal Arm: The first test lens for this arm, etafilcon A sphere, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted.

Repeat for the second lens (multifocal).


Participant Flow for 2 periods

Period 1:   Period 1
    Etafilcon A Multifocal/ Etafilcon A Sphere     Etafilcon A Sphere/ Etafilcon A Multifocal  
STARTED     25     24  
COMPLETED     25     24  
NOT COMPLETED     0     0  

Period 2:   Period 2
    Etafilcon A Multifocal/ Etafilcon A Sphere     Etafilcon A Sphere/ Etafilcon A Multifocal  
STARTED     25 [1]   24 [1]
COMPLETED     25     24  
NOT COMPLETED     0     0  
[1] Crossover study: the completed from period 1 will crossover in period 2 to the opposite arm.



  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
Etafilcon A Multifocal/ Etafilcon A Sphere etafilcon A multifocal/ etafilcon A sphere Arm: The first test lens for this arm, etafilcon A multifocal, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted. Repeat for the second lens (sphere).
Etafilcon A Sphere\ Etafilcon A Multifocal

etafilcon A sphere/ etafilcon A multifocal Arm: The first test lens for this arm, etafilcon A sphere, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted.

Repeat for the second lens (multifocal).

Total Total of all reporting groups

Baseline Measures
    Etafilcon A Multifocal/ Etafilcon A Sphere     Etafilcon A Sphere\ Etafilcon A Multifocal     Total  
Number of Participants  
[units: participants]
  25     24     49  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     25     24     49  
>=65 years     0     0     0  
Age [1]
[units: years]
Mean ± Standard Deviation
  42.3  ± 3.4     42.3  ± 3.4     42.3  ± 3.4  
Gender  
[units: participants]
     
Female     18     18     36  
Male     7     6     13  
[1] Mean age was the same for both groups.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire   [ Time Frame: week 4 ]

2.  Primary:   Monocular Amplitude of Accommodation   [ Time Frame: week 4 ]

3.  Secondary:   Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ   [ Time Frame: week 4 ]

4.  Secondary:   Subject Reported Lens Comfort Using CLUE Questionnaire   [ Time Frame: week 4 ]

5.  Secondary:   Comfortable Wearing Time   [ Time Frame: week 4 ]

6.  Secondary:   Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper   [ Time Frame: Baseline ]


  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
No text entered.


  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 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: Thomas R. Karkkainen OD, MS, FAAO Senior Principal Research Optometrist
Organization: Johnson & Johnson Vision Care
phone: (904)443-3402
e-mail: TKarkkai@its.jnj.com


No publications provided


Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01016652     History of Changes
Other Study ID Numbers: CR-4558, VMFL-511
Study First Received: November 18, 2009
Results First Received: September 19, 2013
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board