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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01435460
First received: September 14, 2011
Last updated: February 17, 2012
Last verified: February 2012
Results First Received: February 17, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (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  
Number of Participants  
[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)  
Safety Issue No  

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  
Number of 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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