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Phase 4 Completed N=204 Randomized Single-blind Treatment

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

Source: ClinicalTrials.gov NCT00735449 ↗
Enrolled (actual)
204
Serious AEs
1.0%
Results posted
Nov 2011
Primary outcomePrimary: Mean Intraocular Pressure (IOP) at 10 AM at Week 12 — 15.1; 16.9 Millimeters of mercury (mmHg)

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Intraocular Pressure (IOP) at 10 AM at Week 12
15.1; 16.9
SECONDARY
Mean Intraocular Pressure (IOP) at 10 AM at Week 6
15.9; 16.7
SECONDARY
Mean Intraocular Pressure (IOP) at 8 AM at Week 12
17.0; 17.7
SECONDARY
Mean Intraocular Pressure (IOP) at 8 AM at Week 6
17.3; 17.8
SECONDARY
Number of Subjects With Adverse Events
15; 13

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00735449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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