Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)

• Sponsor: Alcon Research (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00758342
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0% (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004% (Travatan) once daily. The study is double masked. The patients will receive either treatment for 12 weeks.

Condition or Disease	Intervention/Treatment	Phase
Intraocular Pressure	Drug: Travoprost 0.004% + Brinzolamide 1.0%; Drug: Travoprost 0.004% + Tears Natural	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-Masked, Parallel-Group, Efficacy and Safety Study of Brinzolamide 1.0% (AZOPT) as Adjunctive Therapy to Travoprost 0.004% (TRAVATAN) in Patients With Chronic Angle-Closure Glaucoma
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Travoprost 0.004% + Brinzolamide 1.0% Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)	Drug: Travoprost 0.004% + Brinzolamide 1.0%; Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
Active Comparator: Travoprost 0.004% + Tears Natural Travoprost 0.004% (once daily) + Tears Naturale (twice daily)	Drug: Travoprost 0.004% + Tears Natural; Travoprost 0.004% (once daily) + Tears Naturale (twice daily)

Outcome Measures

Primary Outcome Measures

1. Mean IOP (Intraocular Pressure) [Screening: Week 12; (At 9 am and 4 pm time points)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ≥ 18 years;

• CACG (Chronic Angle Closure Glaucoma) ≥ 1eye

• have been treated with PGA (prostaglandin analogues) once daily ≥ 2 weeks prior to the screening visit and IOP=19-32 mmHg (millimeters mercury) in at least one eye and ≤ 32 mmHg in both eyes

• clinical stability of VA (Visual Acuity) and optic nerve throughout the study

Exclusion Criteria:

• Abnormality restricts exam of the fundus or anderior chamber

• conjunctivitis, keratitis or uveitis

• unable to be discontinued from using all ocular hypotensive medication(s) except Travatan (Travoprost 0.004%) and/or Azopt (Brinzolamide 1.0%) for 12days-4weeks

• ocular surgery prior to the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Call Center	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00758342
• Other Study ID Numbers: MS-06-01
• First Posted: Sep 25, 2008
• Last Update Posted: Mar 2, 2010
• Last Verified: Feb 1, 2010

• Keywords provided by , ,: IOP lowering efficacy and safety of Azopt plus Travatan
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Angle-Closure; Travoprost; Brinzolamide

Study Results

Participant Flow

Arm/Group Title	Travoprost 0.004% + Brinzolamide 1.0%	Travoprost 0.004% + Tears Natural
Arm/Group Description	Travoprost 0.004% + Brinzolamide 1.0%	Travoprost 0.004% + Tears Natural
Period Title: Overall Study
STARTED	19	18
COMPLETED	15	17
NOT COMPLETED	4	1

Baseline Characteristics

Arm/Group Title	Travoprost 0.004% + Brinzolamide 1.0%	Travoprost 0.004% + Tears Natural	Total
Arm/Group Description	Travoprost 0.004% + Brinzolamide 1.0%	Travoprost 0.004% + Tears Natural	Total of all reporting groups
Overall Participants	19	18	37
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	11 57.9%	15 83.3%	26 70.3%
>=65 years	8 42.1%	3 16.7%	11 29.7%
Sex: Female, Male (Count of Participants)
Female	14 73.7%	11 61.1%	25 67.6%
Male	5 26.3%	7 38.9%	12 32.4%

Outcome Measures

1. Primary Outcome

Title	Mean IOP (Intraocular Pressure)
Time Frame	Screening: Week 12; (At 9 am and 4 pm time points)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Travoprost 0.004% + Brinzolamide 1.0%	Travoprost 0.004% + Tears Natural
Arm/Group Description	Travoprost 0.004% + Brinzolamide 1.0%	Travoprost 0.004% + Tears Natural
Measure Participants	19	18
9 AM measurement	17.58 (4.29)	20.59 (3.70)
4 PM measurement	17.11 (4.50)	18.50 (3.05)

Adverse Events

Arm/Group Title	Travoprost 0.004% + Brinzolamide 1.0%		Travoprost 0.004% + Tears Natural
Arm/Group Description	Travoprost 0.004% + Brinzolamide 1.0%		Travoprost 0.004% + Tears Natural
All Cause Mortality
	Travoprost 0.004% + Brinzolamide 1.0%		Travoprost 0.004% + Tears Natural
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Travoprost 0.004% + Brinzolamide 1.0%		Travoprost 0.004% + Tears Natural
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Travoprost 0.004% + Brinzolamide 1.0%		Travoprost 0.004% + Tears Natural
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Confidentiality agreement