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Trial record 21 of 328 for:    contact lens | Studies With Results

Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 1

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ClinicalTrials.gov Identifier: NCT01684033
Recruitment Status : Completed
First Posted : September 12, 2012
Results First Posted : April 17, 2014
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions: Myopia
Hyperopia
Contact Lens Comfort
Interventions: Device: Opti-Free® PureMoist® MPDS
Device: Biotrue™ MPS
Device: Habitual 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
Participants were recruited from 5 study centers located in the US, 3 study centers located in the UK, and 2 study centers located in Germany.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 207 enrolled, 9 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants who were exposed to a study regimen (test or control) (198).

Reporting Groups
  Description
PureMoist - Biotrue Opti-Free® PureMoist® MPDS, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses.
Biotrue - PureMoist Biotrue™ MPS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.

Participant Flow for 2 periods

Period 1:   Period 1, First 30 Days
    PureMoist - Biotrue   Biotrue - PureMoist
STARTED   99   99 
COMPLETED   95   98 
NOT COMPLETED   4   1 
Adverse Event                1                1 
Noncompliance                1                0 
Withdrawal by Subject                1                0 
Lost to Follow-up                1                0 

Period 2:   Period 2, Second 30 Days
    PureMoist - Biotrue   Biotrue - PureMoist
STARTED   95   98 
COMPLETED   94   98 
NOT COMPLETED   1   0 
Adverse Event                1                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 participants who were exposed to a study regimen (test or control).

Reporting Groups
  Description
PureMoist / Biotrue Opti-Free® PureMoist® MPDS and Biotrue™ MPS used during Period 1 and Period 2 in randomized order in crossover assignment.

Baseline Measures
   PureMoist / Biotrue 
Overall Participants Analyzed 
[Units: Participants]
 198 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.7  (11.48) 
Gender 
[Units: Participants]
 
Female   151 
Male   47 


  Outcome Measures

1.  Primary:   Corneal Staining   [ Time Frame: Day 30 ]

2.  Primary:   Change From Baseline in Corneal Staining at Day 30   [ Time Frame: Baseline (Day 0), Day 30 ]


  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: Jessie Lemp, GMA Brand Lead
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com



Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01684033     History of Changes
Other Study ID Numbers: M-12-038
1941/ALC
First Submitted: September 10, 2012
First Posted: September 12, 2012
Results First Submitted: March 12, 2014
Results First Posted: April 17, 2014
Last Update Posted: April 17, 2014