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Trial record 7 of 80 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 : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Robert Ritch, MD, LLC.

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
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 0.5% 0.7%
Hide Arm/Group Description

0.5% Rho-Kinase Inhibitor

AR-12286

0.7% Rho-Kinase Inhibitor

AR-12286

Period Title: Overall Study
Started 5 5
Completed 4 5
Not Completed 1 0
Arm/Group Title 0.5% 0.7% Total
Hide Arm/Group Description

0.5% Rho-Kinase Inhibitor

AR-12286

0.7% Rho-Kinase Inhibitor

AR-12286

Total of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  40.0%
0
   0.0%
2
  20.0%
>=65 years
3
  60.0%
5
 100.0%
8
  80.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
2
  40.0%
2
  40.0%
4
  40.0%
Male
3
  60.0%
3
  60.0%
6
  60.0%
1.Primary Outcome
Title Evaluate the Ocular Hypotensive Efficacy of Rho Kinase Inhibitor (AR-12286 0.5% and 0.7%)
Hide Description Goldmann Aplanation Tonometry (IOP mmHg) will be used to measure the ocular hypotensive efficacy.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.5% 0.7%
Hide Arm/Group Description:

0.5% Rho-Kinase Inhibitor

AR-12286

0.7% Rho-Kinase Inhibitor

AR-12286

Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: mmHg
24.2  (2.4) 25.8  (2.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0.5% 0.7%
Hide Arm/Group Description

0.5% Rho-Kinase Inhibitor

AR-12286

0.7% Rho-Kinase Inhibitor

AR-12286

All-Cause Mortality
0.5% 0.7%
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
0.5% 0.7%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
0.5% 0.7%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      0/5 (0.00%)    
Eye disorders     
Conjunctivitis  1/5 (20.00%)  1 0/5 (0.00%)  0
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
Responsible Party: Robert Ritch, MD, LLC.
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: November 16, 2018