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

NCT02140060 | Completed Phase 2 Results

• 1 other identifier: C-14-003
• Study Type: interventional
• Target: 327
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate Travoprost/Brinzolamide fixed combination (Trav/Brinz) administered twice daily as compared to each of its marketed components (TRAVATAN Z® solution and AZOPT® suspension) and to the unfixed combination of TRAVATAN Z® plus AZOPT® in lowering intraocular pressure (IOP).

Conditions

Glaucoma; Ocular Hypertension

Keywords

Glaucoma; Ocular; Hypertension; OAG; POAG; OHT

Outcome Measures

Primary Outcomes (1)

• Mean IOP at Week 6

  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.

  Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM

Study Arms (6)

TravA/Brinz

EXPERIMENTAL

Dose Level A / Brinzolamide 1% ophthalmic suspension (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

Drug: Dose Level A / Brinzolamide 1% ophthalmic suspension; Drug: Travoprost solution vehicle

TravB/Brinz

EXPERIMENTAL

Dose Level B / Brinzolamide 1% ophthalmic suspension (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

Drug: Dose Level B / Brinzolamide 1% ophthalmic suspension; Drug: Travoprost solution vehicle

TravC/Brinz

EXPERIMENTAL

Dose Level C / Brinzolamide 1% ophthalmic suspension (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

Drug: Dose Level C / Brinzolamide 1% ophthalmic suspension; Drug: Travoprost solution vehicle

AZOPT

ACTIVE COMPARATOR

Brinzolamide 1% 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

Drug: Brinzolamide 1% ophthalmic suspension AZOPT®; Drug: Travoprost solution vehicle

TRAV Z

ACTIVE COMPARATOR

Brinzolamide 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

Drug: Travoprost 0.004% ophthalmic solution TRAVATAN Z®; Drug: Brinzolamide suspension vehicle

TRAV Z + AZOPT

ACTIVE COMPARATOR

Brinzolamide 1% 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

Drug: Brinzolamide 1% ophthalmic suspension AZOPT®; Drug: Travoprost 0.004% ophthalmic solution TRAVATAN Z®

Interventions

Dose Level A / Brinzolamide 1% ophthalmic suspension DRUG

Fixed combination

TravA/Brinz

Dose Level B / Brinzolamide 1% ophthalmic suspension DRUG

Fixed combination

TravB/Brinz

Dose Level C / Brinzolamide 1% ophthalmic suspension DRUG

Fixed combination

TravC/Brinz

Brinzolamide 1% ophthalmic suspension AZOPT® DRUG

Also known as: AZOPT®

AZOPT; TRAV Z + AZOPT

Travoprost 0.004% ophthalmic solution TRAVATAN Z® DRUG

Also known as: TRAVATAN Z®

TRAV Z; TRAV Z + AZOPT

Travoprost solution vehicle DRUG

Inactive ingredients used for masking purposes

AZOPT; TravA/Brinz; TravB/Brinz; TravC/Brinz

Brinzolamide suspension vehicle DRUG

Inactive ingredients used for masking purposes

TRAV Z

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;
• IOP within the protocol-specified range at both the Eligibility 1 and 2 Visits. Mean IOP must not be \>36 mmHg at any time point;
• Able to understand and sign an informed consent form;

You may not qualify if:

• Woman of childbearing potential who is currently pregnant, intends to become pregnant during the study period, breastfeeding, or not using adequate birth control methods to prevent pregnancy throughout the study;
• Unable to discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to the E1 Visit;
• Chronic, recurrent or severe inflammatory eye disease;
• Ocular trauma within the past 6 months prior to the Screening Visit;
• Ocular infection or ocular inflammation within the past 3 months prior to the Screening Visit;
• Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment;
• Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal);
• Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of a topical prostaglandin analogue or topical carbonic anhydrase inhibitor;
• Intraocular surgery within the past 6 months prior to the Screening Visit;
• Ocular laser surgery within the past 3 months prior to the Screening Visit;
• Any abnormality preventing reliable applanation tonometry;
• Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;
• History of hepatic or renal disease that would preclude the safe administration of a carbonic anhydrase inhibitor (CAI) in the opinion of the Investigator;
• Hypersensitivity to prostaglandin analogues, topical or oral CAIs, sulfonamide derivatives, or to any component of the study medications in the opinion of the Investigator;
• Recent (within 4 weeks of the Eligibility 1 Visit) use of high dose (\> 1 g daily) salicylate therapy;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Hypertension

Interventions

brinzolamide; Travoprost

Condition Hierarchy (Ancestors)

Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Clinical Project Lead, GCRA, Pharma
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr. Clinical Manager, GCRA, Pharma

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 16, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 29, 2015
• Results First Posted: December 29, 2015

Record last verified: 2015-11