Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension

Allergan

Status and phase: Completed; Phase 4

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

Treatments: Drug: bimatoprost ophthalmic solution 0.01%; Drug: travoprost ophthalmic solution 0.004%; Drug: latanoprost ophthalmic solution 0.005%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01253902

GMA-LUM-09-014

Details and patient eligibility

About

This study evaluated the ocular surface tolerability of the prostaglandin analogues bimatoprost ophthalmic solution 0.01% (Lumigan® 0.01%), travoprost ophthalmic solution 0.004% (Travatan Z®) and latanoprost ophthalmic solution 0.005% (Xalatan®) in patients previously treated with Xalatan® who have open-angle glaucoma or ocular hypertension.

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of ocular hypertension or open-angle glaucoma in at least 1 eye requiring treatment with an anti-glaucoma/ocular hypertensive medication
• Best corrected visual acuity score of 20/100 or better in both eyes
• Females on birth control pills must be on same type of pill and dose for at least 3 month

Exclusion criteria

• Use of Lumigan® 0.01%/Lumigan® RC, Lumigan®, Travatan® or Travatan Z® within 6 months
• History of or active ocular infection/inflammation (eg, uveitis)
• Punctal plug use
• Required use of ocular medications during the study other than study medication (intermittent use of certain types artificial tears acceptable)
• Intraocular surgery or glaucoma laser surgery in study eye(s) within 3 months
• History of corneal refractive laser surgery (eg, LASIK, LASEK) in study eye(s)
• Planned contact lens wear during study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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164 participants in 3 patient groups

bimatoprost ophthalmic solution 0.01%

Active Comparator group

Description:

One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.

Treatment:

Drug: bimatoprost ophthalmic solution 0.01%

travoprost ophthalmic solution 0.004%

Active Comparator group

Description:

One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.

Treatment:

Drug: travoprost ophthalmic solution 0.004%

latanoprost ophthalmic solution 0.005%

Active Comparator group

Description:

One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.

Treatment:

Drug: latanoprost ophthalmic solution 0.005%