Safety and Efficacy of a Drug Delivery System in Glaucoma

Vistakon Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Open-angle Glaucoma

Ocular Hypertension

Treatments

Drug: Placebo Device

Drug: High Dose Drug Device

Drug: bimatoprost 0.03%

Drug: Low Dose Drug Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT01016691

CR-1649

Details and patient eligibility

About

Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.

Enrollment

47 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Man or woman 21 years of age or greater
Open angle glaucoma or ocular hypertension
Corrected visual acuity in each eye of 20/200 or better

Exclusion criteria

Previous glaucoma intraocular surgery or refractive surgery
Planned contact lens use during the study
Clinically significant ocular or systemic disease that might interfere with the study
Use of chronic corticosteroids by any route

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

47 participants in 3 patient groups

High Dose Drug Device/ bimatoprost 0.03%

Experimental group

Description:

drug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).

Treatment:

Drug: High Dose Drug Device

Drug: bimatoprost 0.03%

Low Dose Drug Device / bimatoprost 0.03%

Experimental group

Description:

drug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).

Treatment:

Drug: Low Dose Drug Device

Drug: bimatoprost 0.03%

Placebo Device / bimatoprost 0.03%

Other group

Description:

placebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period).

Treatment:

Drug: Placebo Device

Drug: bimatoprost 0.03%