Dry Eye Assessment and Management: Feasibility Study (DREAM)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Penny Asbell, Asbell, Penny, M.D.
ClinicalTrials.gov Identifier:
NCT01102257
First received: April 9, 2010
Last updated: July 20, 2012
Last verified: July 2012
Results First Received: April 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Dry Eye Syndromes
Keratoconjunctivitis Sicca
Interventions: Drug: Omega-3 EFA Supplement
Drug: Olive Oil

  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
No text entered.

Reporting Groups
  Description
Omega-3 Supplement 5 Gel Capsules to be taken orally daily to give a total dose of 2000mg EPA and 1000 mg DHA
Olive Oil 5 Gel Capsules of olive oil to be taken orally daily

Participant Flow:   Overall Study
    Omega-3 Supplement     Olive Oil  
STARTED     9     9  
COMPLETED     7 [1]   9  
NOT COMPLETED     2     0  
Adverse Event                 1                 0  
Adverse Event                 1                 0  
[1] 2 withdrew from the study d/t adverse events. 1 had shortness of breath and the other had chest pain



  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
Omega-3 Supplement 5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA
Olive Oil 5 Gel Capsules of olive oil taken orally daily
Total Total of all reporting groups

Baseline Measures
    Omega-3 Supplement     Olive Oil     Total  
Number of Participants  
[units: participants]
  9     9     18  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     6     12  
>=65 years     3     3     6  
Age  
[units: years]
Mean ± Standard Deviation
  55  ± 14     57  ± 15     56  ± 14  
Gender  
[units: participants]
     
Female     8     7     15  
Male     1     2     3  
Region of Enrollment  
[units: participants]
     
United States     9     9     18  



  Outcome Measures

1.  Primary:   Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content   [ Time Frame: Baseline and 3 Months ]

2.  Primary:   Change on Ocular Surface Disease Index (OSDI)   [ Time Frame: 90 +/- 14 days following initiation of drug regimen ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Change on Brief Ocular Discomfort Inventory (BODI)   [ Time Frame: 90 +/- 14 days following initiation of drug regimen ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Change on Impact of Dry Eye on Everyday Life (IDEEL)   [ Time Frame: 90 +/- 14 days following initiation of drug regimen ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Change in Quality of Life Associated With Chronic Pain   [ Time Frame: 90 +/- 14 days following initiation of drug regimen ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Change in the Ocular Surface   [ Time Frame: 90 +/- 14 days following initiation of drug regimen ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Change in Schirmer’s   [ Time Frame: 90 +/- 14 days following initiation of drug regimen ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

8.  Secondary:   Change in Relevant Biomarkers: HLA-DR, MUC 5A, Cytokines   [ Time Frame: 90 +/- 14 days following initiation of drug regimen ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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
DREAM: Feasibility Study, is labeled “feasibility” because its primary end-point is to demonstrate an ability to execute the protocol rather than generate statistically relevant data on the safety and efficacy of omega-3 EFA in patients with DED.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Penny Asbell
Organization: Mount Sinai School of Medicine
phone: (212) 241-7977
e-mail: penny.asbell@mssm.edu


No publications provided


Responsible Party: Penny Asbell, Asbell, Penny, M.D.
ClinicalTrials.gov Identifier: NCT01102257     History of Changes
Other Study ID Numbers: 05-1099, 1R34EY017626
Study First Received: April 9, 2010
Results First Received: April 29, 2011
Last Updated: July 20, 2012
Health Authority: United States: Food and Drug Administration