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Trial record 7 of 75 for:    PEELING SKIN SYNDROME

A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma (ROCK)

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ClinicalTrials.gov Identifier: NCT01936389
Recruitment Status : Completed
First Posted : September 6, 2013
Results First Posted : April 24, 2015
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
Glaucoma Associates of New York

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Exfoliation Syndrome
Ocular Hypertension
Open Angle Glaucoma
Intervention: Drug: AR-12286

  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
0.5%

0.5% Rho-Kinase Inhibitor

AR-12286

0.7%

0.7% Rho-Kinase Inhibitor

AR-12286


Participant Flow:   Overall Study
    0.5%   0.7%
STARTED   5   5 
COMPLETED   4   5 
NOT COMPLETED   1   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.
No text entered.

Reporting Groups
  Description
0.5%

0.5% Rho-Kinase Inhibitor

AR-12286

0.7%

0.7% Rho-Kinase Inhibitor

AR-12286

Total Total of all reporting groups

Baseline Measures
   0.5%   0.7%   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   5   10 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   2   0   2 
>=65 years   3   5   8 
Gender 
[Units: Participants]
     
Female   2   2   4 
Male   3   3   6 


  Outcome Measures

1.  Primary:   Evaluate the Ocular Hypotensive Efficacy of Rho Kinase Inhibitor (AR-12286 0.5% and 0.7%)   [ Time Frame: 6 months ]


  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: Jessica Jasien, MEn
Organization: NYGRI
phone: 2124777540 ext 371
e-mail: jjasien.ganyresearch@gmail.com



Responsible Party: Glaucoma Associates of New York
ClinicalTrials.gov Identifier: NCT01936389     History of Changes
Other Study ID Numbers: 12286
First Submitted: August 28, 2013
First Posted: September 6, 2013
Results First Submitted: October 10, 2014
Results First Posted: April 24, 2015
Last Update Posted: April 24, 2015