Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Allergan

Status and phase: Completed; Phase 4

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: bimatoprost 0.03% ophthalmic solution; Drug: bimatoprost 0.01% ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01298700

192024-054

2010-023917-68 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular hypertension.

Enrollment: 806 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ocular hypertension or glaucoma in each eye
• Requires intraocular pressure (IOP)-lowering therapy in both eyes
• Best corrected visual acuity of 20/100 or better in each eye

Exclusion criteria

• Ocular seasonal allergies within 2 years
• Required chronic use of ocular medications during the study (intermittent use of artificial tears is allowed)
• Ocular surgery or laser within 3 months
• Anticipated wearing of contact lenses during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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806 participants in 2 patient groups

Bimatoprost 0.01% Ophthalmic Solution

Experimental group

Description:

One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.

Treatment:

Drug: bimatoprost 0.01% ophthalmic solution

Bimatoprost 0.03% Ophthalmic Solution

Active Comparator group

Description:

One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.

Treatment:

Drug: bimatoprost 0.03% ophthalmic solution