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Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Adults With OHT or POAG

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ClinicalTrials.gov Identifier: NCT02829996
Recruitment Status : Completed
First Posted : July 12, 2016
Results First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Inotek Pharmaceuticals Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Primary Open-Angle Glaucoma (POAG)
Ocular Hypertension (OHT)
Interventions Drug: trabodenoson 6.0% / latanoprost 0.005% QD
Drug: trabodenoson 3.0% / latanoprost 0.005% QD
Drug: trabodenoson 6.0% / latanoprost 0.0025% QD
Drug: latanoprost 0.005% QD
Drug: latanoprost 0.0025% QD
Enrollment 201
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trabodenoson 6.0% / Latanoprost 0.005% QD Trabodenoson 3.0% / Latanoprost 0.005% QD Trabodenoson 6.0% / Latanoprost 0.0025% QD Latanoprost 0.005% QD Latanoprost 0.0025% QD
Hide Arm/Group Description

trabodenoson 6.0% / latanoprost 0.005% Fixed-Dose Combination

trabodenoson 6.0% / latanoprost 0.005% QD: Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

trabodenoson 3.0% / latanoprost 0.005% Fixed-Dose Combination

trabodenoson 3.0% / latanoprost 0.005% QD: Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

trabodenoson 6.0% / latanoprost 0.0025% Fixed-Dose Combination

trabodenoson 6.0% / latanoprost 0.0025% QD: Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

latanoprost 0.005% ophthalmic solution

latanoprost 0.005% QD: Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

latanoprost 0.0025% ophthalmic solution

latanoprost 0.0025% QD: Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

Period Title: Overall Study
Started 39 39 40 41 42
Completed 38 39 40 41 42
Not Completed 1 0 0 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0             0
Arm/Group Title Trabodenoson 6.0% / Latanoprost 0.005% QD Trabodenoson 3.0% / Latanoprost 0.005% QD Trabodenoson 6.0% / Latanoprost 0.0025% QD Latanoprost 0.005% QD Latanoprost 0.0025% QD Total
Hide Arm/Group Description

trabodenoson 6.0% / latanoprost 0.005% Fixed-Dose Combination

trabodenoson 6.0% / latanoprost 0.005% QD: Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

trabodenoson 3.0% / latanoprost 0.005% Fixed-Dose Combination

trabodenoson 3.0% / latanoprost 0.005% QD: Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

trabodenoson 6.0% / latanoprost 0.0025% Fixed-Dose Combination

trabodenoson 6.0% / latanoprost 0.0025% QD: Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

latanoprost 0.005% ophthalmic solution

latanoprost 0.005% QD: Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

latanoprost 0.0025% ophthalmic solution

latanoprost 0.0025% QD: Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 39 39 40 41 42 201
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 39 participants 40 participants 41 participants 42 participants 201 participants
64.1  (12.08) 64.4  (9.18) 68.8  (8.43) 66.5  (9.84) 66.4  (8.57) 66.0  (9.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 39 participants 40 participants 41 participants 42 participants 201 participants
Female
17
  43.6%
23
  59.0%
19
  47.5%
22
  53.7%
27
  64.3%
108
  53.7%
Male
22
  56.4%
16
  41.0%
21
  52.5%
19
  46.3%
15
  35.7%
93
  46.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 39 participants 40 participants 41 participants 42 participants 201 participants
American Indian or Alaska Native
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.5%
Asian
1
   2.6%
2
   5.1%
1
   2.5%
0
   0.0%
0
   0.0%
4
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  20.5%
9
  23.1%
8
  20.0%
9
  22.0%
10
  23.8%
44
  21.9%
White
30
  76.9%
27
  69.2%
31
  77.5%
32
  78.0%
32
  76.2%
152
  75.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants 39 participants 40 participants 41 participants 42 participants 201 participants
39 39 40 41 42 201
Baseline IOP   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm of mercury
Number Analyzed 39 participants 39 participants 40 participants 41 participants 42 participants 201 participants
27.67  (2.329) 27.17  (2.278) 27.28  (2.155) 27.48  (2.627) 27.31  (2.276) 27.38  (2.323)
[1]
Measure Description: mm of mercury on Goldmann Applanation Tonometry
1.Primary Outcome
Title Mean Intraocular Pressure (IOP)
Hide Description Daily change from diurnal baseline in IOP
Time Frame Two Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Trabodenoson 6.0% / Latanoprost 0.005% QD Trabodenoson 3.0% / Latanoprost 0.005% QD Trabodenoson 6.0% / Latanoprost 0.0025% QD Latanoprost 0.005% QD Latanoprost 0.0025% QD
Hide Arm/Group Description:

trabodenoson 6.0% / latanoprost 0.005% Fixed-Dose Combination

trabodenoson 6.0% / latanoprost 0.005% QD: Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

trabodenoson 3.0% / latanoprost 0.005% Fixed-Dose Combination

trabodenoson 3.0% / latanoprost 0.005% QD: Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

trabodenoson 6.0% / latanoprost 0.0025% Fixed-Dose Combination

trabodenoson 6.0% / latanoprost 0.0025% QD: Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

latanoprost 0.005% ophthalmic solution

latanoprost 0.005% QD: Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

latanoprost 0.0025% ophthalmic solution

latanoprost 0.0025% QD: Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

Overall Number of Participants Analyzed 39 39 40 41 42
Mean (Standard Error)
Unit of Measure: mm of mercury
-6.4  (0.48) -6.8  (0.56) -6.4  (0.56) -7.1  (0.46) -5.9  (0.53)
2.Other Pre-specified Outcome
Title Safety Parameters, Including Treatment Emergent Adverse Events, to Assess Tolerability and Safety.
Hide Description Collection of safety parameters, including treatment emergent adverse events, laboratory assessments, to assess tolerability and safety.
Time Frame Through Study Completion, up to 9 weeks.
Outcome Measure Data Not Reported
Time Frame 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trabodenoson 6.0% / Latanoprost 0.005% QD Trabodenoson 3.0% / Latanoprost 0.005% QD Trabodenoson 6.0% / Latanoprost 0.0025% QD Latanoprost 0.005% QD Latanoprost 0.0025% QD
Hide Arm/Group Description

trabodenoson 6.0% / latanoprost 0.005% Fixed-Dose Combination

trabodenoson 6.0% / latanoprost 0.005% QD: Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

trabodenoson 3.0% / latanoprost 0.005% Fixed-Dose Combination

trabodenoson 3.0% / latanoprost 0.005% QD: Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

trabodenoson 6.0% / latanoprost 0.0025% Fixed-Dose Combination

trabodenoson 6.0% / latanoprost 0.0025% QD: Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

latanoprost 0.005% ophthalmic solution

latanoprost 0.005% QD: Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

latanoprost 0.0025% ophthalmic solution

latanoprost 0.0025% QD: Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.

All-Cause Mortality
Trabodenoson 6.0% / Latanoprost 0.005% QD Trabodenoson 3.0% / Latanoprost 0.005% QD Trabodenoson 6.0% / Latanoprost 0.0025% QD Latanoprost 0.005% QD Latanoprost 0.0025% QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)      0/39 (0.00%)      0/40 (0.00%)      0/41 (0.00%)      0/42 (0.00%)    
Hide Serious Adverse Events
Trabodenoson 6.0% / Latanoprost 0.005% QD Trabodenoson 3.0% / Latanoprost 0.005% QD Trabodenoson 6.0% / Latanoprost 0.0025% QD Latanoprost 0.005% QD Latanoprost 0.0025% QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/39 (0.00%)      0/39 (0.00%)      0/40 (0.00%)      0/41 (0.00%)      0/42 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Trabodenoson 6.0% / Latanoprost 0.005% QD Trabodenoson 3.0% / Latanoprost 0.005% QD Trabodenoson 6.0% / Latanoprost 0.0025% QD Latanoprost 0.005% QD Latanoprost 0.0025% QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/39 (23.08%)      5/39 (12.82%)      6/40 (15.00%)      3/41 (7.32%)      5/42 (11.90%)    
Eye disorders           
Eye Discharge  1  2/39 (5.13%)  2 0/39 (0.00%)  0 1/40 (2.50%)  1 0/41 (0.00%)  0 0/42 (0.00%)  0
Conjunctival Hyperaemia  1  1/39 (2.56%)  1 2/39 (5.13%)  2 1/40 (2.50%)  1 0/41 (0.00%)  0 1/42 (2.38%)  1
Punctate Keratitis  1  1/39 (2.56%)  1 2/39 (5.13%)  2 1/40 (2.50%)  1 0/41 (0.00%)  0 1/42 (2.38%)  1
Infections and infestations           
UTI  1  4/39 (10.26%)  4 1/39 (2.56%)  1 1/40 (2.50%)  1 1/41 (2.44%)  1 2/42 (4.76%)  2
Upper Respiratory Infection  1  1/39 (2.56%)  1 0/39 (0.00%)  0 2/40 (5.00%)  2 2/41 (4.88%)  2 1/42 (2.38%)  2
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Roni Cohen
Organization: Inotek Pharmaceuticals Corp.
Phone: 781-676-2100
EMail: rcohen@inotekpharma.com
Layout table for additonal information
Responsible Party: Inotek Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT02829996    
Other Study ID Numbers: IPC-02-2015
First Submitted: July 8, 2016
First Posted: July 12, 2016
Results First Submitted: November 28, 2017
Results First Posted: February 15, 2018
Last Update Posted: February 15, 2018