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Circadian Rhythms of Aqueous Humor Dynamics in Humans

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ClinicalTrials.gov Identifier: NCT00572936
Recruitment Status : Completed
First Posted : December 13, 2007
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Carol B. Toris, BA MS PhD, University of Nebraska

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Glaucoma
Interventions: Drug: Latanoprost
Drug: Dorzolamide
Drug: Timolol

  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
One patient who was taking latanoprost for ocular hypertension did not have an IOP rise greater than 20mmHg after discontinuing treatment for up to 12 weeks. A second patient who initially expressed interest chose to withdraw from the study.

Reporting Groups
  Description
Latanoprost/Dorzolamide/Timolol The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
Latanoprost/Timolol/Dorzolamide The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
Dorzolamide/Latanoprost/Timolol The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
Dorzolamide/Timolol/Latanoprost The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
Timolol/Dorzolamide/Latanoprost The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.
Timolol/Latanoprost/Dorzolamide The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.

Participant Flow for 3 periods

Period 1:   First Intervention
    Latanoprost/Dorzolamide/Timolol   Latanoprost/Timolol/Dorzolamide   Dorzolamide/Latanoprost/Timolol   Dorzolamide/Timolol/Latanoprost   Timolol/Dorzolamide/Latanoprost   Timolol/Latanoprost/Dorzolamide
STARTED   4   4   5   5   5   5 
COMPLETED   4   4   5   5   5   5 
NOT COMPLETED   0   0   0   0   0   0 

Period 2:   Second Intervention
    Latanoprost/Dorzolamide/Timolol   Latanoprost/Timolol/Dorzolamide   Dorzolamide/Latanoprost/Timolol   Dorzolamide/Timolol/Latanoprost   Timolol/Dorzolamide/Latanoprost   Timolol/Latanoprost/Dorzolamide
STARTED   4   3 [1]   4 [2]   5   4 [2]   5 
COMPLETED   4   3   4   5   4   5 
NOT COMPLETED   0   0   0   0   0   0 
[1] 1 participant dropped out between the first and second intervention due to car accident
[2] 1 participant dropped out between first intervention and second intervention due to increased IOP

Period 3:   Third Intervention
    Latanoprost/Dorzolamide/Timolol   Latanoprost/Timolol/Dorzolamide   Dorzolamide/Latanoprost/Timolol   Dorzolamide/Timolol/Latanoprost   Timolol/Dorzolamide/Latanoprost   Timolol/Latanoprost/Dorzolamide
STARTED   4   3   4   5   3 [1]   5 
COMPLETED   4   3   4   5   3   5 
NOT COMPLETED   0   0   0   0   0   0 
[1] 1 participant dropped out between second intervention and third intervention due to increased IOP



  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
Latanoprost/Dorzolamide/Timolol The participants received latanoprost at night and vehicle in the morning for two weeks, then 6 week washout, then Dorzolamide BID for two weeks, then 6 week washout, then Timolol BID for two weeks. The order in which the participants received the three different drugs was random.

Baseline Measures
   Latanoprost/Dorzolamide/Timolol 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Years]
Mean (Standard Deviation)
 59  (11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      21  70.0% 
Male      9  30.0% 


  Outcome Measures

1.  Primary:   Intraocular Pressure   [ Time Frame: 2 weeks ]

2.  Primary:   Aqueous Flow   [ Time Frame: 2 weeks ]

3.  Primary:   Central Corneal Thickness   [ Time Frame: 2 weeks ]

4.  Primary:   Anterior Chamber Volume   [ Time Frame: 2 weeks ]

5.  Primary:   Blood Pressure   [ Time Frame: 2 weeks ]

6.  Primary:   Episcleral Venous Pressure   [ Time Frame: 2 weeks ]

7.  Primary:   Outflow Facility   [ Time Frame: 2 weeks ]

8.  Primary:   Uvescleral Outflow   [ Time Frame: 2 weeks ]


  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:  
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: Carol Toris, PhD
Organization: UNMC
phone: 402-559-1852
e-mail: ctoris@unmc.edu


Publications of Results:

Responsible Party: Carol B. Toris, BA MS PhD, University of Nebraska
ClinicalTrials.gov Identifier: NCT00572936     History of Changes
Other Study ID Numbers: 405-05-FB
First Submitted: December 7, 2007
First Posted: December 13, 2007
Results First Submitted: October 24, 2017
Results First Posted: February 14, 2018
Last Update Posted: February 14, 2018