NCT00759941

Brief Summary

The purpose of this study was to assess the efficacy of adding Azopt dosed three times a day to Xalatan as compared to that of adding placebo to Xalatan in patients with elevated intraocular pressure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

August 16, 2012

Completed
Last Updated

January 13, 2014

Status Verified

July 1, 2012

Enrollment Period

1.8 years

First QC Date

September 24, 2008

Results QC Date

July 12, 2012

Last Update Submit

December 11, 2013

Conditions

Glaucoma

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (4)

  • Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months

    Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.

    Day 0, 3 months

  • Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months

    Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.

    Day 0, 3 months

  • Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months

    Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.

    Day 0, 3 months

  • Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months

    Diurnal intraocular pressure is the mean of the three timepoints measured (8AM, 12PM \& 4PM). Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in mean intraocular pressure.

    Day 0, 3 months

Study Arms (2)

Xalatan + Azopt

EXPERIMENTAL

Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.

Drug: Brinzolamide 1% ophthalmic solution (Azopt)Drug: Latanoprost 0.005% ophthalmic solution (Xalatan)

Xalatan + Placebo

ACTIVE COMPARATOR

Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.

Drug: Placebo eye dropsDrug: Latanoprost 0.005% ophthalmic solution (Xalatan)

Interventions

Brinzolamide 1% ophthalmic solution (Azopt)DRUG

One drop three times a day in both eyes for 3 months

Also known as: AZOPT
Xalatan + Azopt
Placebo eye dropsDRUG

One drop three times a day in both eyes for 3 months

Xalatan + Placebo
Latanoprost 0.005% ophthalmic solution (Xalatan)DRUG

One drop once a day in both eyes for 3 months

Also known as: Xalatan
Xalatan + AzoptXalatan + Placebo

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral or bilateral primary open angle glaucoma, ocular hypertension or pseudoexfoliation syndrome.
  • Intraocular pressure greater than 18 mmHg (mean diurnal) and less than 32 mmHg.

You may not qualify if:

  • Previous intraocular surgery, except uncomplicated clear cornea phacoemulsification or argon laser trabeculoplasty.
  • Argon laser trabeculoplasty or phacoemulsification within the last 3 months.
  • Central corneal thickness outside the 500 - 600 (inclusive) micron range as measured by ultrasonic pachymetry.
  • Ocular or periocular inflammation within 3 months prior to study (except blepharitis related or seasonal allergic conjunctivitis).
  • History of uveitis or previous intraocular inflammation (other than post-operatively).
  • Hypersensitivity to sulfa, or benzalkonium chloride.
  • History of use of any steroids for over 1 week within 3 months of screening or likely need for any corticosteroids during the study (except inhaled, nasal or topical non-ocular).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

brinzolamideOphthalmic SolutionsLatanoprost

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of ChemicalsProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Results Point of Contact

Title
Head, Global Medical Affairs
Organization
Alcon Research, Ltd.
medinfo@alconlabs.com
800-862-5266

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2008

First Posted

September 25, 2008

Study Start

October 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

January 13, 2014

Results First Posted

August 16, 2012

Record last verified: 2012-07

Locations

US(1)