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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:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00885092
First received: April 17, 2009
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
Results First Received: February 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, 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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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  
Number of Participants  
[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
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1.  Primary:   Mean Ex-Vivo Wetting Angle   [ Time Frame: Day 7, Hour 14 ]
  Show Outcome Measure 1

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

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


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


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


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00885092     History of Changes
Other Study ID Numbers: C-08-082
Study First Received: April 17, 2009
Results First Received: February 24, 2012
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board