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Effects of Anti-Glaucoma Medications on the Ocular Surface (BAK)

This study has been terminated.
(Slow Enrollment)
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01315574
First received: March 10, 2011
Last updated: February 7, 2017
Last verified: January 2015
Results First Received: August 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Glaucoma
Interventions: Drug: Travoprost
Drug: Latanoprost

  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
Participants recruited from May 2011 to June 2013

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
Latanoprost (Xalatan)

7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.

Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.

Travoprost (Travatan Z)

7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.

Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.


Participant Flow:   Overall Study
    Latanoprost (Xalatan)   Travoprost (Travatan Z)
STARTED   7   7 
COMPLETED   7   7 
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.
* For IOP the baseline sample size for Latanoprost is 6 patients, whereas for all other outcome measures n= 7 patients.

Reporting Groups
  Description
Latanoprost (Xalatan)

7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.

Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.

Travoprost (Travatan Z)

7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.

Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.

Total Total of all reporting groups

Baseline Measures
   Latanoprost (Xalatan)   Travoprost (Travatan Z)   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   7   14 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.3  (7.9)   68.3  (10.0)   66.8  (8.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  71.4%      5  71.4%      10  71.4% 
Male      2  28.6%      2  28.6%      4  28.6% 
Region of Enrollment [1] 
[Units: Participants]
     
United States   7   7   14 
[1] Participant population: newly diagnosed glaucoma patients.
Central Corneal Dendritic Cell Density 
[Units: Cells/mm^2]
Mean (Standard Deviation)
 126  (88)   91  (60)   109  (75) 
Intraocular Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 21  (6)   22  (4)   21.5  (4.8) 
Corneal Fluorescein Staining Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.6  (1.1)   1.3  (2.0)   0.9  (1.6) 
[1] Corneal fluorescein staining scores range from 0 to 4 points: 0=non-staining to 4 =regional whole staining of the cornea. Higher scores indicate worse eye condition.
Tear Break-Up Time (TBUT) 
[Units: Seconds]
Mean (Standard Deviation)
 7.9  (2.0)   8.4  (3.7)   8.1  (2.9) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effectiveness in Lowering Intraocular Pressure   [ Time Frame: At the 6 month follow-up time point ]

2.  Secondary:   Corneal Fluorescein Staining Score   [ Time Frame: At the 6 month follow-up time point ]

3.  Secondary:   Tear Film Break-Up Time   [ Time Frame: At the 6 month follow-up time point ]


  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
Early termination due to very slow rate of recruitment, hence reduced power of the study (small sample size); some patients lost to follow-up.


  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: Dr. Pedram Hamrah
Organization: Massachusetts Eye and Ear Infirmary
phone: 617-573-6060
e-mail: ophthalmologyclinicalresearch@meei.harvard.edu



Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01315574     History of Changes
Other Study ID Numbers: 11-007H
Study First Received: March 10, 2011
Results First Received: August 15, 2016
Last Updated: February 7, 2017