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

Allergan

Status and phase: Completed; Phase 4

Conditions: Glaucoma; Ocular Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01170884

GMA-COM-09-013

Details and patient eligibility

About

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

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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121 participants in 2 patient groups

Combigan® + Lumigan®

Active Comparator group

Description:

COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)

Treatment:

Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution

Lumigan®

Active Comparator group

Description:

LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes

Treatment:

Drug: bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops