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Single Site Study of the Wettability of Contact Lenses With an Investigational Multi-Purpose Disinfecting Solution vs. a Marketed Multi-Purpose Solution

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00885092
First Posted: April 21, 2009
Last Update Posted: March 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
Results First Submitted: February 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition: Contact Lens Care
Interventions: Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)
Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)
Device: Senofilcon A contact lens (ACUVUE® Oasys™)
Device: Balafilcon A contact lens (PureVision®)

  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
Participants were recruited from one US study center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
40 participants with normal eyes (other than vision correction) were enrolled in the trial. After the screening visit, participants discontinued contact lens wear and wore their glasses for at least 2 days as a washout prior to Period 1. A similar washout occurred prior to Period 2. Cross-over study design.

Reporting Groups
  Description
FID 114675A / RepleniSH FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
RepleniSH / FID 114675A RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.

Participant Flow for 2 periods

Period 1:   Period 1, 7 Days
    FID 114675A / RepleniSH   RepleniSH / FID 114675A
STARTED   20   20 
COMPLETED   20   20 
NOT COMPLETED   0   0 

Period 2:   Period 2, 7 Days
    FID 114675A / RepleniSH   RepleniSH / FID 114675A
STARTED   20   20 
COMPLETED   20   20 
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
FID 114675A / RepleniSH FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period.
RepleniSH / FID 114675A RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period.
Total Total of all reporting groups

Baseline Measures
   FID 114675A / RepleniSH   RepleniSH / FID 114675A   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.9  (10.1)   42.4  (10.0)   42.6  (10.0) 
Gender 
[Units: Participants]
     
Female   12   11   23 
Male   8   9   17 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Ex-Vivo Wetting Angle   [ Time Frame: Day 7, Hour 14 ]

2.  Secondary:   Mean Lens Comfort   [ Time Frame: Day 7, Hour 14 ]

3.  Secondary:   Percentage of Participants With Solution-Related Corneal Staining   [ Time Frame: Day 7, Hour 14 ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Director of Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: medinfo@alconlabs.com



Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00885092     History of Changes
Other Study ID Numbers: C-08-082
First Submitted: April 17, 2009
First Posted: April 21, 2009
Results First Submitted: February 24, 2012
Results First Posted: March 20, 2012
Last Update Posted: March 27, 2012