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

This study is not yet open for participant recruitment.
Verified November 2012 by Adapt Produtos Oftalmológicos Ltda.
Sponsor:
Information provided by (Responsible Party):
Adapt Produtos Oftalmológicos Ltda.
ClinicalTrials.gov Identifier:
NCT01721707
First received: November 2, 2012
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Open Angle Glaucoma
Ocular Hypertension
Drug: Latanoprost+Brinzolamide combination
Drug: Latanoprost
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy to Reduce the IOP of the Fixed Association of Latanoprost 0.005% (50 μg/mL)/ Brinzolamide 1% (10mg/mL) Drops, Compared to Latanoprost 0.005% (50 μg/mL) Drops, in Patients With Open Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by Adapt Produtos Oftalmológicos Ltda.:

Primary Outcome Measures:
  • IOP [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Change in mean diurnal IOP compared to baseline (Month 3)


Secondary Outcome Measures:
  • IOP changes [ Time Frame: week 2, week 6, month 3 ] [ Designated as safety issue: No ]
    Change in mean IOP from baseline (week 2, week 6, month 3)

  • IOP measures [ Time Frame: week 2, week 6, month 3 ] [ Designated as safety issue: No ]
    Percentage of patients with IOP <18 mmHg at each visit during therapy and timepoint (week 2, week 6, month 3)


Other Outcome Measures:
  • Biomicroscopy / Fundus examination [ Time Frame: Week 2, Week 6, Month 3 ] [ Designated as safety issue: Yes ]
    relevant changes observed by physician during biomicroscopy and fundus examination

  • BCVA [ Time Frame: Week 2, Week 6, Month 3 ] [ Designated as safety issue: Yes ]
    Decrease of visual acuity observed by BCVA examination


Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Latanoprost+Brinzolamide combination
Latanoprost 0.005%(50 mg/ml)+brinzolamide 1%(10mg/ml) eye drops
Drug: Latanoprost+Brinzolamide combination
1 drop in each eye, 1x/day, at 9PM
Other Name: Latanoprost 0.005% (50 mg / ml) / brinzolamide 1% (10mg/ml) eye drops
Active Comparator: Latanoprost
Latanoprost 0.005% (50 mg / ml)
Drug: Latanoprost
1 drop in each eye, 1x/day, at 9PM
Other Name: Latanoprost 0.005% (50 mg / ml)

Detailed Description:

The study is divided into two sequential phases. The Phase I trial is a Phase Screening / Eligibility, which includes a screening visit, followed by 2 Visits Eligibility (3 visits). The Phase II study is the treatment phase randomized, double-masked that includes visits during therapy at Week 2, Week 6 and Month 3

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    1. currently pregnant or
    2. have tested positive in urine pregnancy Screening Visit or
    3. planning to become pregnant during the study period, or
    4. 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).
  • Intraocular surgery within the last 6 months.
  • Laser eye surgery in the last 3 months.
  • Any abnormality that prevents a reliable applanation tonometry.
  • Any other condition including severe illness that would make the patient, in the opinion of the investigator, unsuitable for the study.
  • History of cardiovascular disease (eg, coronary heart disease, hypertension, Raynaud's phenomenon, orthostatic hypotension, thromboangiitis), cerebrovascular (eg, cerebral insufficiency), active liver or kidney, severe, unstable or uncontrolled that would prevent the safe administration of an alpha-adrenergic topic or CAI in the opinion of the investigator.

Related to previous or concomitant medications

  • Patients with recent use (within 4 weeks of Visit Eligibility 1) salicylate therapy with high dose (> 1 g daily).
  • Current or planned treatment with any psychotropic drug that increases the adrenergic response (eg, desipramine, amitriptyline).
  • Concomitant use of monoamine oxidase inhibitors.
  • Therapy with another investigational agent within 30 days prior to the Screening Visit.
  • Hypersensitivity to the drug alpha-adrenergic agonists, oral or topical CAIs, sulfonamide derivatives or any component of the study drugs in the opinion of the investigator.
  • Less than 30 days regimen with stable administration before the Screening Visit any medications or substances administered by any route and used chronically that may affect IOP, including among others, β-adrenergic blocking agents.
  • Use of ocular hypotensive medication any additional topical or systemic throughout the study.
  • Concomitant use of glucocorticoids administered by any route.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721707

Contacts
Contact: Cristina Muccioli, MD 5511-99748809 crissmucci@gmail.com
Contact: Luci Silva, MBA 5511-71571967 luci.pesquisa@gmail.com

Locations
Brazil
Department of Ophthalmology / Hospital São Paulo Not yet recruiting
São Paulo, Brazil, 04023062
Sponsors and Collaborators
Adapt Produtos Oftalmológicos Ltda.
Investigators
Principal Investigator: Rubens Belfort Jr, MD Federal University of São Paulo / Hospital São Paulo
  More Information

No publications provided

Responsible Party: Adapt Produtos Oftalmológicos Ltda.
ClinicalTrials.gov Identifier: NCT01721707     History of Changes
Other Study ID Numbers: BRINZLAT-12, 08233812.4.0000.5505
Study First Received: November 2, 2012
Last Updated: November 5, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Adapt Produtos Oftalmológicos Ltda.:
glaucoma
ocular hypertension
latanoprost
brinzolamide

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Latanoprost
Brinzolamide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014