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Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01435460
First Posted: September 16, 2011
Last Update Posted: March 13, 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):
Bausch & Lomb Incorporated
Results First Submitted: February 17, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Seasonal Allergic Conjunctivitis
Interventions: Drug: Loteprednol etabonate 0.2%
Drug: Olopatadine 0.1%

  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
Three hundred participants were enrolled in the study. First participant was enrolled 08/03/2010, last participant exited on 04/26/2011. This study was conducted at 7 sites in China.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three hundred participants were randomized into two groups, 151 to be treated with Alrex and 149 to be treated with Patanol.

Reporting Groups
  Description
Alrex Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
Patanol Ophthalmic solution containing olopatadine, 0.1%

Participant Flow:   Overall Study
    Alrex   Patanol
STARTED   151   149 
COMPLETED   140   143 
NOT COMPLETED   11   6 
Adverse Event                2                1 
Lost to Follow-up                6                1 
Withdrawal by Subject                1                3 
Protocol Violation                0                1 
Did not meet eligibility criteria                2                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
Alrex Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
Patanol Ophthalmic solution containing olopatadine, 0.1%
Total Total of all reporting groups

Baseline Measures
   Alrex   Patanol   Total 
Overall Participants Analyzed 
[Units: Participants]
 151   149   300 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.5  (14.01)   40.6  (12.85)   40.6  (13.43) 
Gender 
[Units: Participants]
     
Female   99   103   202 
Male   52   46   98 
Race/Ethnicity, Customized 
[Units: Participants]
     
Chinese   151   149   300 


  Outcome Measures
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1.  Primary:   Bulbar Conjunctival Injection   [ Time Frame: Change from baseline to day 15 (visit 3) ]
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Measure Type Primary
Measure Title Bulbar Conjunctival Injection
Measure Description Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe
Time Frame Change from baseline to day 15 (visit 3)  

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.
Participants analyzed from the per protocol (PP) population

Reporting Groups
  Description
Alrex Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
Patanol Ophthalmic solution containing olopatadine, 0.1%

Measured Values
   Alrex   Patanol 
Participants Analyzed 
[Units: Participants]
 138   142 
Bulbar Conjunctival Injection 
[Units: Units on a scale]
Mean (Standard Deviation)
 -1.91  (0.521)   -1.71  (0.585) 

No statistical analysis provided for Bulbar Conjunctival Injection



2.  Primary:   Ocular Itching   [ Time Frame: Change from baseline to day 15 (visit 3) ]

3.  Secondary:   Bulbar Conjunctival Injection   [ Time Frame: Change from baseline to day 8 (visit 2) ]

4.  Secondary:   Ocular Itching   [ Time Frame: Change from baseline to day 8 (visit 2) ]


  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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