Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00544713
First received: October 12, 2007
Last updated: November 9, 2011
Last verified: November 2011
Results First Received: June 29, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Dry Eye Syndrome
Interventions: Drug: Carboxymethylcellulose and Glycerin based artificial tear
Drug: Carboxymethylcellulose

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Carboxymethylcellulose and Glycerin Based Artificial Tear Carboxymethylcellulose and Glycerin based artificial tear
Carboxymethylcellulose Based Artificial Tear Carboxymethylcellulose based artificial tear

Participant Flow:   Overall Study
    Carboxymethylcellulose and Glycerin Based Artificial Tear     Carboxymethylcellulose Based Artificial Tear  
STARTED     114     114  
COMPLETED     111     109  
NOT COMPLETED     3     5  



  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.
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Reporting Groups
  Description
Carboxymethylcellulose and Glycerin Based Artificial Tear Carboxymethylcellulose and Glycerin based artificial tear
Carboxymethylcellulose Based Artificial Tear Carboxymethylcellulose based artificial tear
Total Total of all reporting groups

Baseline Measures
    Carboxymethylcellulose and Glycerin Based Artificial Tear     Carboxymethylcellulose Based Artificial Tear     Total  
Number of Participants  
[units: participants]
  114     114     228  
Age, Customized  
[units: participants]
     
<40 Years     88     92     180  
>= 40 Years     26     22     48  
Gender  
[units: participants]
     
Female     62     51     113  
Male     52     63     115  



  Outcome Measures
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1.  Primary:   Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90   [ Time Frame: Day 90 ]

2.  Secondary:   Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90   [ Time Frame: Day 90 ]

3.  Secondary:   Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90   [ Time Frame: Day 90 ]

4.  Secondary:   Best Corrected Visual Acuity (BCVA) Status at Day 90   [ Time Frame: Day 90 ]

5.  Secondary:   Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90   [ Time Frame: Baseline, Day 90 ]

6.  Secondary:   Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90   [ Time Frame: Baseline, Day 90 ]

7.  Secondary:   Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90   [ Time Frame: Baseline, Day 90 ]

8.  Secondary:   Change From Baseline of the Worse Eye in Schirmer's Test at Day 90   [ Time Frame: Baseline, Day 90 ]

9.  Secondary:   Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90   [ Time Frame: Baseline, Day 90 ]

10.  Secondary:   Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90   [ Time Frame: Baseline, Day 90 ]

11.  Secondary:   Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90   [ Time Frame: Baseline, Day 90 ]

12.  Secondary:   Change From Baseline in Study Product Usage at Day 90   [ Time Frame: Baseline, Day 90 ]

13.  Other Pre-specified:   Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60   [ Time Frame: Day 14, Day 60 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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: Therapeutic Area Head
Organization: Allergan, Inc.
phone: (714)246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00544713     History of Changes
Other Study ID Numbers: AG9818-001
Study First Received: October 12, 2007
Results First Received: June 29, 2009
Last Updated: November 9, 2011
Health Authority: United States: Institutional Review Board