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Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®

Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma; Ocular Hypertension

Intervention: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution (Drug); bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

Summary

Comparing Safety and Efficacy of Combigan and Lumigan with Lumigan Alone in Glaucoma or Ocular Hypertension Subjects Treated with Xalatan.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Mean Diurnal Intraocular Pressure (IOP) at Week 12

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosed with glaucoma or ocular hypertension.

- Visual Acuity 20/100 or better in both eyes

Exclusion Criteria:

- Any active ocular disease

- History of any intraocular surgery or glaucoma laser surgery within 3 months

- Contraindication to pupil dilation

- Use of topical, periorbital, intravitreal, or systemic steroid within 3 months

Locations and Contacts

Dallas, Texas, United States
Additional Information

Starting date: December 2009
Last updated: December 7, 2011

Page last updated: August 23, 2015

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