Latanoprost/Brinzolamide BID Versus Latanoprost BID in Patients With OAG or OH

NCT01721707 | Withdrawn Phase 3

• 2 other identifiers: BRINZLAT-1208233812.4.0000.5505
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a double-masked, randomized, parallel group study in patients with open angle glaucoma or ocular hypertension. The aim of this study is to verify the efficacy of the fixed combination of Latanoprost 50 mcg / mL / brinzolamide 10mg/ml eye drops compared to Latanoprost 50μg/mL eye drops in reducing IOP

Conditions

Open Angle Glaucoma; Ocular Hypertension

Keywords

glaucoma; ocular hypertension; latanoprost; brinzolamide

Outcome Measures

Primary Outcomes (1)

• IOP

  Change in mean diurnal IOP compared to baseline (Month 3)

  Month 3

Secondary Outcomes (2)

• IOP changes

  week 2, week 6, month 3

• IOP measures

  week 2, week 6, month 3

Other Outcomes (2)

• Biomicroscopy / Fundus examination

  Week 2, Week 6, Month 3

• BCVA

  Week 2, Week 6, Month 3

Study Arms (2)

Latanoprost+Brinzolamide combination

EXPERIMENTAL

Latanoprost 0.005%(50 mg/ml)+brinzolamide 1%(10mg/ml) eye drops

Drug: Latanoprost+Brinzolamide combination

Latanoprost

ACTIVE COMPARATOR

Latanoprost 0.005% (50 mg / ml)

Drug: Latanoprost

Interventions

Latanoprost+Brinzolamide combination DRUG

1 drop in each eye, 1x/day, at 9PM

Also known as: Latanoprost 0.005% (50 mg / ml) / brinzolamide 1% (10mg/ml) eye drops

Latanoprost+Brinzolamide combination

Latanoprost DRUG

1 drop in each eye, 1x/day, at 9PM

Also known as: Latanoprost 0.005% (50 mg / ml)

Latanoprost

Eligibility Criteria

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

You may qualify if:

• Patients 18 years of age or older, of either gender and of any race / ethnicity, diagnosed with open angle glaucoma or ocular hypertension, which in the opinion of the investigator does not have enough control with monotherapy or already receiving multiple medications for lowering IOP .
• Patients should be able to understand and sign an informed consent form that has been approved by an Institutional Review Board.
• Measurements of mean IOP in at least 1 eye:
• ≥ 24 mmHg and ≤ 36 mmHg at timepoint 9am and
• ≥ 21 mmHg and ≤ 36 mmHg in the 11h timepoint in both Visits Eligibility 1 and after washout of any medication to reduce IOP.
• The mean IOP should not be\> 36 mmHg at any timepoint

You may not qualify if:

• Fertile women (those not surgically sterile or postmenopausal for at least 1 year) are excluded from study participation if meet any of the following conditions:
• currently pregnant or
• have tested positive in urine pregnancy Screening Visit or
• planning to become pregnant during the study period, or
• are breastfeeding, or not using highly effective contraceptive precautions.
• Patients with angle Schaffer Grade \<2, as measured by gonioscopy (extreme narrow angle with complete or partial closure).
• Patients with a ratio cup / disc greater than 0.80 (horizontal or vertical).
• Patients presenting with loss of central visual field impairment. The loss of central visual field is defined as a serious sensitivity less than or equal to 10 dB in at least four points of two visual field test closest to the point of attachment.
• Patients who can not safely discontinue use of all medications to ocular IOP reduction for a minimum of 5 days ± 1 day to 28 days ± 1 day prior to Visit E1.
• Chronic inflammatory eye disease, recurrent or severe (ie, scleritis, uveitis, herpetic keratitis).
• Ocular trauma in the past 6 months.
• Eye infection or inflammation of the eye in the last 3 months.
• Retinal disease as clinically significant or progressive retinal degeneration, diabetic retinopathy or retinal detachment.
• Best score corrected visual acuity (BCVA) worse than 55 ETDRS letters (equivalent to approximately 20/80 Snellen).
• Another ocular pathology (including severe dry eye) that may, in the opinion of the investigator, preventing the administration of an alpha-adrenergic agonist and/or an inhibitor of topical carbonic anhydrase (CAI).

Sponsors & Collaborators

• Adapt Produtos Oftalmológicos Ltda.: lead

Study Sites (1)

Department of Ophthalmology / Hospital São Paulo

São Paulo, São Paulo, 04023062, Brazil

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Interventions

Latanoprost; brinzolamide; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Rubens Belfort Jr, MD

  Federal University of São Paulo / Hospital São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 6, 2012
• Study Start: December 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 11, 2014

Record last verified: 2014-12

Locations

BR (1)