Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects

Glaucoma Clinical Trial

Official title:

Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735449
• Other study ID #: GMA-COM-07-XTC
• Status: Completed
• Phase: Phase 4
• Start date: July 2008
• Est. completion date: December 2009

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be at least 18 years of age

• Give written informed consent

• Be in good general health as determined by your doctor

• Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension

• If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills)

• Understand the study instructions, and be able to follow the study instructions; and

• Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits

Exclusion Criteria:

• Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation

• History of severe renal or hepatic impairment

• Subjects with severe cardiovascular disease should not be enrolled unless their disease is controlled and clearance has been obtained from the subject's primary care physician and/or cardiologist

• Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure and cardiogenic shock or uncontrolled congestive heart failure

• Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and

• Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the screening visit

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%
1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.
• timolol maleate 0.5%
1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.
• latanoprost 0.005%
1 drop of latanoprost 0.005% once nightly.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Fechtner RD, Harasymowycz P, Nixon DR, Vold SD, Zaman F, Williams JM, Hollander DA. Twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost. Clin Ophthalmol. 2011;5:945-53. doi: 10.2147/OPTH.S19999. Epub 2011 Jul 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Intraocular Pressure (IOP) at 10 AM at Week 12	Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.	Week 12
Secondary	Mean Intraocular Pressure (IOP) at 10 AM at Week 6	Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.	Week 6
Secondary	Mean Intraocular Pressure (IOP) at 8 AM at Week 12	Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.	Week 12
Secondary	Mean Intraocular Pressure (IOP) at 8 AM at Week 6	Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.	Week 6
Secondary	Number of Subjects With Adverse Events	Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit).	Week 12