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Glaucoma Biomarkers

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ClinicalTrials.gov Identifier: NCT01677507
Recruitment Status : Completed
First Posted : September 3, 2012
Results First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Collaborators:
University of Nebraska
Mayo Clinic
National Eye Institute (NEI)
Information provided by (Responsible Party):
Sayoko E. Moroi, University of Michigan

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Glaucoma
Healthy
Intervention: Drug: Variation in eye pressure response to timolol and latanoprost treatment

  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

135 consented. Prior to baseline measures: 4 were excluded for ineligibility; 6 withdrew consent fully prior to baseline measurements.

After baseline measures: an additional 2 were excluded based on physician decision, and 2 withdrew for participant decision.

Thus, 121 participants are included for period 1.


Reporting Groups
  Description
Timolol Followed by Latanoprost

To compare the variation in response to timolol between individuals

Variation in eye pressure response to timolol and latanoprost treatment: Arm 1 initial period is to test for variation in eye pressure response to timolol 0.5%, then washout.

Period 2 is to test for variation in eye pressure response to latanoprost 0.005%.

Latanoprost Followed by Timolol

To compare the variation in response to latanoprost between individuals

Variation in eye pressure response to timolol and latanoprost treatment:

Arm 1 initial period is to test for variation in eye pressure response to latanoprost 0.005%, then washout.

Period 2 is to test for variation in eye pressure response to timolol 0.5%.


Participant Flow for 2 periods

Period 1:   Initial Assignment
    Timolol Followed by Latanoprost   Latanoprost Followed by Timolol
STARTED   63   58 
COMPLETED   63   56 
NOT COMPLETED   0   2 
Adverse Event                0                1 
Protocol Violation                0                1 

Period 2:   Second Assigment
    Timolol Followed by Latanoprost   Latanoprost Followed by Timolol
STARTED   63   56 
COMPLETED   60   51 
NOT COMPLETED   3   5 
Withdrawal by Subject                2                2 
Adverse Event                1                3 



  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.
In addition to the 119 participants who were randomized to actual treatment, the baseline population includes the 9 who came for full baseline measurements before they were excluded or chose to withdraw.

Reporting Groups
  Description
Baseline of Entire Population Both arms are included because the study design was a cross over intent to treat with glaucoma medications. All participants were treated with both medications.

Baseline Measures
   Baseline of Entire Population 
Overall Participants Analyzed 
[Units: Participants]
 125 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 125 
   55.1  (8.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 125 
Female      94  75.2% 
Male      31  24.8% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 125 
White      107  85.6% 
Asian      2   1.6% 
Hispanic      3   2.4% 
Black or African American      12   9.6% 
American Indian      1   0.8% 
Region of Enrollment 
[Units: Participants]
 
United States   
Participants Analyzed 
[Units: Participants]
 125 
United States   125 
Intraocular pressure 
[Units: mmHg]
Mean (Standard Deviation)
 
Right eye   
Participants Analyzed 
[Units: Participants]
 125 
Right eye   14.4  (3.5) 
Left eye   
Participants Analyzed 
[Units: Participants]
 125 
Left eye   13.9  (3.5) 
Aqueous humor flow [1] 
[Units: Microliters/min]
Mean (Standard Deviation)
 
Right eye   
Participants Analyzed 
[Units: Participants]
 123 
Right eye   3.1  (1.2) 
Left eye   
Participants Analyzed 
[Units: Participants]
 123 
Left eye   2.9  (0.9) 
[1] There was missing aqueous flow data on 2 participants.
Episcleral venous pressure [1] 
[Units: mmHg]
Mean (Standard Deviation)
 
Right eye   
Participants Analyzed 
[Units: Participants]
 96 
Right eye   8.3  (1.7) 
Left eye   
Participants Analyzed 
[Units: Participants]
 125 
Left eye   7.9  (1.5) 
[1] One site used a different method to measure episcleral venous pressure (n=29)


  Outcome Measures

1.  Primary:   Variation in Eye Pressure Between Individuals.   [ Time Frame: Measurement after 1 week of drug treatment ]

2.  Secondary:   Variation in Aqueous Flow Between Individuals.   [ Time Frame: 1 week after treatment ]

3.  Secondary:   Variation in Episcleral Venous Pressure.   [ Time Frame: 1 week treatment ]


  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
No text entered.


  More Information

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


Results Point of Contact:  
Name/Title: Dr. Sayoko Moroi
Organization: University of Michigan
phone: 734-763-3732
e-mail: smoroi@med.umich.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sayoko E. Moroi, University of Michigan
ClinicalTrials.gov Identifier: NCT01677507     History of Changes
Other Study ID Numbers: HUM00052276
R01EY022124 ( U.S. NIH Grant/Contract )
First Submitted: August 7, 2012
First Posted: September 3, 2012
Results First Submitted: August 14, 2017
Results First Posted: September 13, 2017
Last Update Posted: September 13, 2017