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Multifocal High ADD Contact Lens Proof of Concept Trial

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ClinicalTrials.gov Identifier: NCT02117544
Recruitment Status : Completed
First Posted : April 21, 2014
Results First Posted : August 17, 2015
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Presbyopia
Interventions: Device: Lotrafilcon B multifocal contact lenses (new)
Device: Lotrafilcon B multifocal contact lenses

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from 7 study centers located in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 268 enrolled, 159 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (109).

Reporting Groups
  Description
New MF, Then AOAMF Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally for about 1 hour.
AOAMF, Then New MF Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally for about 1 hour.

Participant Flow for 2 periods

Period 1:   Period 1
    New MF, Then AOAMF   AOAMF, Then New MF
STARTED   54   55 
Treated   52   55 
COMPLETED   52   55 
NOT COMPLETED   2   0 
Lost to follow-up (prior to treatment)                2                0 

Period 2:   Period 2
    New MF, Then AOAMF   AOAMF, Then New MF
STARTED   52   55 
COMPLETED   52   55 
NOT COMPLETED   0   0 



  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.
This analysis population includes all randomized and treated subjects.

Reporting Groups
  Description
Overall AIR OPTIX® AQUA Multifocal and lotrafilcon B Multifocal (new design) contact lenses worn during Period 1 and Period 2 in a crossover assignment.

Baseline Measures
   Overall 
Overall Participants Analyzed 
[Units: Participants]
 107 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.6  (5.0) 
Gender 
[Units: Participants]
 
Female   91 
Male   16 


  Outcome Measures

1.  Primary:   High Contrast Visual Acuity (HCVA) Near Monocular   [ Time Frame: Day 1, 10 minutes after lens insertion, each product ]

2.  Secondary:   HCVA Distance Monocular   [ Time Frame: Day 1, 10 minutes after lens insertion, each product ]

3.  Secondary:   HCVA Intermediate Monocular   [ Time Frame: Day 1, 10 minutes after lens insertion, each product ]

4.  Secondary:   Low Contrast Visual Acuity (LCVA) Distance Monocular   [ Time Frame: Day 1, 10 minutes after lens insertion, each product ]


  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: Clinical Project Lead, Vision Care, GCRA
Organization: Alcon Research, Ltd
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com



Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02117544     History of Changes
Other Study ID Numbers: C-13-057
First Submitted: April 16, 2014
First Posted: April 21, 2014
Results First Submitted: July 21, 2015
Results First Posted: August 17, 2015
Last Update Posted: August 26, 2015