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Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT01294384
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Dry Eye Syndromes
Interventions: Drug: carboxymethylcellulose sodium based New Eye Drop Formulation 1
Drug: carboxymethylcellulose sodium based New Eye Drop Formulation 2
Drug: carboxymethylcellulose sodium based Eye Drops

  Participant Flow

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
New Eye Drop Formulation 1 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
New Eye Drop Formulation 2 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
Refresh Tears® 1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.

Participant Flow:   Overall Study
    New Eye Drop Formulation 1   New Eye Drop Formulation 2   Refresh Tears®
STARTED   101   100   104 
COMPLETED   97   94   95 
NOT COMPLETED   4   6   9 



  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.
No text entered.

Reporting Groups
  Description
New Eye Drop Formulation 1 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
New Eye Drop Formulation 2 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
Refresh Tears® 1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Total Total of all reporting groups

Baseline Measures
   New Eye Drop Formulation 1   New Eye Drop Formulation 2   Refresh Tears®   Total 
Overall Participants Analyzed 
[Units: Participants]
 101   100   104   305 
Age, Customized 
[Units: Participants]
       
< 40 years   9   13   7   29 
40 to 60 years   42   33   43   118 
> 60 years   50   54   54   158 
Gender 
[Units: Participants]
       
Female   78   80   90   248 
Male   23   20   14   57 


  Outcome Measures

1.  Primary:   Change From Baseline in Ocular Surface Disease Index© (OSDI) Score   [ Time Frame: Baseline, Day 90 ]

2.  Secondary:   Change From Baseline in Visual Analog (VAS) Symptom Scale: Dryness   [ Time Frame: Baseline, Day 90 ]

3.  Secondary:   Percentage of Participants Much Better or Better in Near Visual Acuity (Low Contrast)   [ Time Frame: Baseline, Day 90 ]

4.  Secondary:   Percentage of Participants Much Better or Better in Near Visual Acuity (High Contrast)   [ Time Frame: Baseline, Day 90 ]

5.  Secondary:   Change From Baseline in Tear Break-Up Time (TBUT)   [ Time Frame: Baseline, Day 90 ]

6.  Secondary:   Change From Baseline in Corneal Staining   [ Time Frame: Baseline, Day 90 ]

7.  Secondary:   Change From Baseline in Conjunctival Staining   [ Time Frame: Baseline, Day 90 ]

8.  Secondary:   Change From Baseline in Schirmer Test   [ Time Frame: Baseline, Day 90 ]


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



Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01294384     History of Changes
Other Study ID Numbers: 10078X-001
First Submitted: February 10, 2011
First Posted: February 11, 2011
Results First Submitted: September 24, 2013
Results First Posted: November 25, 2013
Last Update Posted: November 25, 2013