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The Effects of an Antioxidant Formulation on Ocular Blood Flow

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ScienceBased Health
ClinicalTrials.gov Identifier:
NCT01930487
First received: August 9, 2013
Last updated: October 13, 2016
Last verified: January 2016
Results First Received: May 31, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Primary Open Angle Glaucoma
Interventions: Dietary Supplement: dietary supplement with antioxidants
Dietary Supplement: Placebo

  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
47 patients were recruited for the study

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1 subject started but did not complete the baseline examination and was not randomized to either treatment arm.

Reporting Groups
  Description
Supplement With Antioxidants, Then Placebo dietary supplement with antioxidants in the first intervention period, followed by placebo supplement in the second intervention period
Placebo, Then Supplement With Antioxidants placebo supplement in the second intervention period, followed by dietary supplement with antioxidants in the second intervention period

Participant Flow for 3 periods

Period 1:   First Intervention (30 Days)
    Supplement With Antioxidants, Then Placebo   Placebo, Then Supplement With Antioxidants
STARTED   21   25 
COMPLETED   19   23 
NOT COMPLETED   2   2 

Period 2:   Washout Period (3 Weeks)
    Supplement With Antioxidants, Then Placebo   Placebo, Then Supplement With Antioxidants
STARTED   19   23 
COMPLETED   19   23 
NOT COMPLETED   0   0 

Period 3:   Second Intervention (30 Days)
    Supplement With Antioxidants, Then Placebo   Placebo, Then Supplement With Antioxidants
STARTED   19   23 
COMPLETED   19   23 
NOT COMPLETED   0   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.
patients who completed both periods of the crossover study

Reporting Groups
  Description
Participants Completing Study Participants who completed both arms of the crossover study

Baseline Measures
   Participants Completing Study 
Overall Participants Analyzed 
[Units: Participants]
 42 
Age 
[Units: Years]
Mean (Standard Deviation)
 67  (11) 
Gender 
[Units: Participants]
 
Female   24 
Male   18 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   7 
White   34 
More than one race   0 
Unknown or Not Reported   1 
Region of Enrollment 
[Units: Participants]
 
United States   42 
Diabetes (Type 2) 
[Units: Participants]
 
yes   21 
no   21 
Hypertension 
[Units: Participants]
 
yes   16 
no   26 
Study Eye 
[Units: Participants]
 
right   24 
left   18 
Duration of OAG 
[Units: Years]
Mean (Standard Deviation)
 15  (8) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Superior Retinal Capillary Blood Flow (% Zero Pixels)   [ Time Frame: baseline and 30 days ]

2.  Primary:   Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels)   [ Time Frame: baseline and 30 days ]

3.  Secondary:   Change in Ocular Perfusion Pressure   [ Time Frame: baseline and 30 days ]

4.  Secondary:   Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s)   [ Time Frame: baseline and 30 days ]

5.  Secondary:   Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s)   [ Time Frame: baseline and 30 days ]

6.  Secondary:   Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)   [ Time Frame: baseline and 30 days ]

7.  Secondary:   Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)   [ Time Frame: baseline and 30 days ]

8.  Secondary:   Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s)   [ Time Frame: baseline and 30 days ]

9.  Secondary:   Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s)   [ Time Frame: baseline and 30 days ]

10.  Secondary:   Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)   [ Time Frame: baseline and 30 days ]

11.  Secondary:   Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)   [ Time Frame: baseline and 30 days ]

12.  Secondary:   Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio)   [ Time Frame: baseline and 30 days ]

13.  Secondary:   Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio)   [ Time Frame: baseline and 30 days ]

14.  Secondary:   Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)   [ Time Frame: baseline and 30 days ]

15.  Secondary:   Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)   [ Time Frame: baseline and 30 days ]

16.  Secondary:   Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM   [ Time Frame: baseline and 30 days ]

17.  Secondary:   Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM   [ Time Frame: baseline and 30 days ]

18.  Secondary:   Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM   [ Time Frame: baseline and 30 days ]

19.  Secondary:   Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM   [ Time Frame: baseline and 30 days ]

20.  Secondary:   Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM   [ Time Frame: baseline and 30 days ]

21.  Secondary:   Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM   [ Time Frame: baseline and 30 days ]

22.  Secondary:   Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM   [ Time Frame: baseline and 30 days ]

23.  Secondary:   Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM   [ Time Frame: baseline and 30 days ]

24.  Secondary:   Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM   [ Time Frame: baseline and 30 days ]

25.  Secondary:   Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM   [ Time Frame: baseline and 30 days ]

26.  Secondary:   Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM   [ Time Frame: baseline and 30 days ]

27.  Secondary:   Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM   [ Time Frame: baseline and 30 days ]

28.  Secondary:   Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM   [ Time Frame: baseline and 30 days ]

29.  Secondary:   Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM   [ Time Frame: baseline and 30 days ]

30.  Secondary:   Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM   [ Time Frame: baseline and 30 days ]

31.  Secondary:   Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM   [ Time Frame: baseline and 30 days ]

32.  Secondary:   Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM   [ Time Frame: baseline and 30 days ]

33.  Secondary:   Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM   [ Time Frame: baseline and 30 days ]

34.  Secondary:   Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM   [ Time Frame: baseline and 30 days ]

35.  Secondary:   Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM   [ Time Frame: baseline and 30 days ]

36.  Secondary:   Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM   [ Time Frame: baseline and 30 days ]

37.  Secondary:   Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM   [ Time Frame: baseline and 30 days ]

38.  Secondary:   Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM   [ Time Frame: baseline and 30 days ]

39.  Secondary:   Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM   [ Time Frame: baseline and 30 days ]

40.  Secondary:   Change in Ocular Perfusion Pressure - DM   [ Time Frame: baseline and 30 days ]

41.  Secondary:   Change in Ocular Perfusion Pressure - No DM   [ Time Frame: baseline and 30 days ]

42.  Secondary:   Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - DM   [ Time Frame: baseline and 30 days ]

43.  Secondary:   Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM   [ Time Frame: baseline and 30 days ]

44.  Secondary:   Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM   [ Time Frame: baseline and 30 days ]

45.  Secondary:   Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM   [ Time Frame: baseline and 30 days ]


  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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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Brent Siesky, PhD, Assistant Director
Organization: Ocular Vascular Research Center, Indiana University School of Medicine
phone: 317-278-0177
e-mail: bsiesky@indiana.edu



Responsible Party: ScienceBased Health
ClinicalTrials.gov Identifier: NCT01930487     History of Changes
Other Study ID Numbers: 007
Study First Received: August 9, 2013
Results First Received: May 31, 2016
Last Updated: October 13, 2016
Health Authority: United States: Institutional Review Board