Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01382225
First received: June 9, 2011
Last updated: May 20, 2013
Last verified: May 2013
Results First Received: May 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dry Eye Syndrome
Interventions: Drug: Sodium Hyaluronate Ophthalmic Solution, 0.18%
Other: Vehicle

  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
Subjects were recruited from 56 investigative sites in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 1936 subjects enrolled, 268 did not qualify for vehicle run-in and were exited as screen failures. Of the 1668 subjects receiving vehicle run-in, 214 did not qualify for randomization and were exited as screen failures. This reporting group includes the 1454 subjects randomized to receive treatment at Baseline Visit (Day 0).

Reporting Groups
  Description
Sodium Hyaluronate Run-in, followed by Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Vehicle Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days

Participant Flow:   Overall Study
    Sodium Hyaluronate     Vehicle  
STARTED     725     729  
COMPLETED     711     722  
NOT COMPLETED     14     7  
Adverse Event                 3                 2  
Protocol Violation                 2                 1  
Subject Withdrew Consent                 5                 2  
Other                 4                 2  



  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.
Of the 1454 subjects randomized, 4 withdrew participation prior to exposure to test article. This reporting group includes the 1450 subjects exposed to test article.

Reporting Groups
  Description
Sodium Hyaluronate Run-in, followed by Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Vehicle Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Total Total of all reporting groups

Baseline Measures
    Sodium Hyaluronate     Vehicle     Total  
Number of Participants  
[units: participants]
  723     727     1450  
Age, Customized  
[units: participants]
     
18-64 years     402     392     794  
≥65 years     321     335     656  
Gender  
[units: participants]
     
Female     590     594     1184  
Male     133     133     266  
Region of Enrollment  
[units: participants]
     
United States     723     727     1450  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7   [ Time Frame: Baseline, Day 7 ]

2.  Primary:   Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7   [ Time Frame: Baseline, Day 7 ]

3.  Secondary:   Change From Baseline in LGS Total Score at Day 14   [ Time Frame: Baseline, Day 14 ]

4.  Secondary:   Change From Baseline in GSF Total Score at Day 14   [ Time Frame: Baseline, Day 14 ]

5.  Secondary:   Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score   [ Time Frame: Baseline, up to Day 14 ]

6.  Secondary:   Percentage Change From Baseline in Schirmer I Score   [ Time Frame: Baseline, up to Day 14 ]

7.  Secondary:   Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score   [ Time Frame: Baseline, up to Day 14 ]

8.  Secondary:   Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score   [ Time Frame: Baseline, up to Day 14 ]

9.  Secondary:   Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating   [ Time Frame: Baseline, Up to Day 14 ]


  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: Michela Montecchi-Palmer, Clinical Project Lead
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01382225     History of Changes
Other Study ID Numbers: C-09-045
Study First Received: June 9, 2011
Results First Received: May 20, 2013
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration