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6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT02140060
Recruitment Status : Completed
First Posted : May 16, 2014
Results First Posted : December 29, 2015
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Glaucoma
Ocular Hypertension
Interventions Drug: Dose Level A / Brinzolamide 1% ophthalmic suspension
Drug: Dose Level B / Brinzolamide 1% ophthalmic suspension
Drug: Dose Level C / Brinzolamide 1% ophthalmic suspension
Drug: Brinzolamide 1% ophthalmic suspension AZOPT®
Drug: Travoprost 0.004% ophthalmic solution TRAVATAN Z®
Drug: Travoprost solution vehicle
Drug: Brinzolamide suspension vehicle
Enrollment 327
Recruitment Details Subjects were recruited from 19 study centers located in the US.
Pre-assignment Details Of the 327 enrolled, 61 subjects were discontinued prior to randomization. This reporting group includes all randomized subjects (266).
Arm/Group Title TravA/Brinz TravB/Brinz TravC/Brinz TRAV Z AZOPT TRAV Z + AZOPT
Hide Arm/Group Description Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
Period Title: Overall Study
Started 44 44 44 45 45 44
Completed 44 44 44 43 44 43
Not Completed 0 0 0 2 1 1
Reason Not Completed
Adverse Event             0             0             0             1             1             1
Lack of Efficacy             0             0             0             1             0             0
Arm/Group Title TravA/Brinz TravB/Brinz TravC/Brinz TRAV Z AZOPT TRAV Z + AZOPT Total
Hide Arm/Group Description Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks Total of all reporting groups
Overall Number of Baseline Participants 44 44 44 45 45 43 265
Hide Baseline Analysis Population Description
This analysis population includes all subjects who were randomized, received study medication, and completed at least 1 scheduled on-therapy study visit.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 44 participants 44 participants 45 participants 45 participants 43 participants 265 participants
65.4  (10.7) 66.2  (10.4) 64.4  (11.2) 64.2  (10.4) 63.1  (8.4) 65.3  (10.6) 64.8  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 44 participants 45 participants 45 participants 43 participants 265 participants
Female
29
  65.9%
26
  59.1%
30
  68.2%
25
  55.6%
23
  51.1%
19
  44.2%
152
  57.4%
Male
15
  34.1%
18
  40.9%
14
  31.8%
20
  44.4%
22
  48.9%
24
  55.8%
113
  42.6%
1.Primary Outcome
Title Mean IOP at Week 6
Hide Description IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) was used for the analysis.
Time Frame Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who were randomized, received study medication, and completed at least 1 scheduled on-therapy study visit, based upon a last on-therapy carried forward (LOCF) analysis. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm, respectively.
Arm/Group Title TravA/Brinz TravB/Brinz TravC/Brinz TRAV Z AZOPT TRAV Z + AZOPT
Hide Arm/Group Description:
Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
Overall Number of Participants Analyzed 44 44 44 45 45 43
Mean (Standard Error)
Unit of Measure: mmHg
8 AM 20.2  (0.52) 18.7  (0.48) 19.9  (0.58) 19.3  (0.48) 22.0  (0.45) 20.3  (0.72)
10 AM 18.9  (0.47) 17.2  (0.35) 18.2  (0.55) 17.4  (0.47) 19.7  (0.50) 18.2  (0.59)
12 PM 18.9  (0.47) 17.3  (0.50) 17.7  (0.51) 17.2  (0.50) 19.5  (0.53) 18.0  (0.57)
4PM 18.5  (0.46) 17.5  (0.43) 17.3  (0.46) 17.6  (0.44) 19.1  (0.50) 18.0  (0.52)
8 PM, n=44, 44, 44, 43, 45, 43 18.4  (0.43) 17.5  (0.39) 17.2  (0.40) 17.3  (0.43) 19.3  (0.48) 18.1  (0.49)
Time Frame Adverse events (AEs) were collected for the duration of a subject’s participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. AEs were obtained through solicited and spontaneous comments from study subjects, and through observations by the study Investigator.
 
Arm/Group Title TravA/Brinz TravB/Brinz TravC/Brinz TRAV Z AZOPT TRAV Z + AZOPT Pre-treatment
Hide Arm/Group Description Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks All subjects who signed an informed consent to participate in the study
All-Cause Mortality
TravA/Brinz TravB/Brinz TravC/Brinz TRAV Z AZOPT TRAV Z + AZOPT Pre-treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
TravA/Brinz TravB/Brinz TravC/Brinz TRAV Z AZOPT TRAV Z + AZOPT Pre-treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/44 (0.00%)   0/44 (0.00%)   1/45 (2.22%)   0/45 (0.00%)   0/44 (0.00%)   1/327 (0.31%) 
Cardiac disorders               
Angina unstable  1  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  1/45 (2.22%)  0/45 (0.00%)  0/44 (0.00%)  0/327 (0.00%) 
Atrial fibrillation  1  0/44 (0.00%)  0/44 (0.00%)  0/44 (0.00%)  0/45 (0.00%)  0/45 (0.00%)  0/44 (0.00%)  1/327 (0.31%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TravA/Brinz TravB/Brinz TravC/Brinz TRAV Z AZOPT TRAV Z + AZOPT Pre-treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/44 (15.91%)   11/44 (25.00%)   15/44 (34.09%)   10/45 (22.22%)   9/45 (20.00%)   13/44 (29.55%)   1/327 (0.31%) 
Eye disorders               
Ocular hyperaemia  1  2/44 (4.55%)  8/44 (18.18%)  6/44 (13.64%)  7/45 (15.56%)  0/45 (0.00%)  8/44 (18.18%)  0/327 (0.00%) 
Conjunctival hyperaemia  1  0/44 (0.00%)  3/44 (6.82%)  3/44 (6.82%)  3/45 (6.67%)  3/45 (6.67%)  3/44 (6.82%)  1/327 (0.31%) 
Eye irritation  1  2/44 (4.55%)  2/44 (4.55%)  2/44 (4.55%)  2/45 (4.44%)  3/45 (6.67%)  1/44 (2.27%)  0/327 (0.00%) 
Eye pain  1  2/44 (4.55%)  2/44 (4.55%)  3/44 (6.82%)  0/45 (0.00%)  1/45 (2.22%)  1/44 (2.27%)  0/327 (0.00%) 
Nervous system disorders               
Dysgeusia  1  2/44 (4.55%)  0/44 (0.00%)  3/44 (6.82%)  1/45 (2.22%)  4/45 (8.89%)  3/44 (6.82%)  0/327 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Project Lead, GCRA, Pharma
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02140060    
Other Study ID Numbers: C-14-003
First Submitted: May 14, 2014
First Posted: May 16, 2014
Results First Submitted: November 24, 2015
Results First Posted: December 29, 2015
Last Update Posted: December 29, 2015