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BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Constellation)

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ClinicalTrials.gov Identifier: NCT01707381
Recruitment Status : Completed
First Posted : October 16, 2012
Results First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Ocular Hypertension
Open Angle Glaucoma
Interventions: Drug: BOL-303259-X
Drug: Timolol maleate

  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
No text entered.

Reporting Groups
  Description
Timolol Maleate Cross Over to BOL-303259X Participants first recieved timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks. Thereafter they received BOL-303259X once in the evening for 4 weeks.
BOL-303259-X Crossover to Timolol Maleate Participants first received BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks. Thereafter, they received timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks.

Participant Flow for 2 periods

Period 1:   Period 1
    Timolol Maleate Cross Over to BOL-303259X   BOL-303259-X Crossover to Timolol Maleate
STARTED   12   13 
COMPLETED   10   11 
NOT COMPLETED   2   2 

Period 2:   Period 2
    Timolol Maleate Cross Over to BOL-303259X   BOL-303259-X Crossover to Timolol Maleate
STARTED   10   11 
COMPLETED   10   11 
NOT COMPLETED   0   0 



  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.
ITT Population: All randomized subjects who received at least one dose of study drug, had a baseline and at least one postbaseline intraocular assessment.

Reporting Groups
  Description
All Study Participants Participants who were randomized to receive either latanoprostene ophthalmic solution 0.024% or timolol maleate 0.5%

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      13  61.9% 
>=65 years      8  38.1% 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.0  (11.13) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      14  66.7% 
Male      7  33.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      4  19.0% 
Not Hispanic or Latino      17  81.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   4.8% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2   9.5% 
White      18  85.7% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Treatment-Naive 
[Units: Participants]
Count of Participants
 15 


  Outcome Measures

1.  Primary:   24 Hour IOP   [ Time Frame: after 4 weeks of treatment ]

2.  Secondary:   24-hour Ocular Perfusion Pressure   [ Time Frame: after 4 weeks of treatment ]

3.  Secondary:   IOP Area Under the Curve Over 24 Hours   [ Time Frame: after 4 weeks of 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:  
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: Heleen DeCory, Ph.D.
Organization: Bausch + Lomb
phone: (585) 338-8161
e-mail: Heleen.DeCory@bausch.com


Publications of Results:

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01707381     History of Changes
Other Study ID Numbers: 803
First Submitted: October 12, 2012
First Posted: October 16, 2012
Results First Submitted: June 11, 2018
Results First Posted: September 3, 2018
Last Update Posted: September 3, 2018