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Safety and Efficacy of a Drug Delivery System in Glaucoma

V

Vistakon Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Open-angle Glaucoma
Ocular Hypertension

Treatments

Drug: bimatoprost 0.03%
Drug: Low Dose Drug Device
Drug: High Dose Drug Device
Drug: Placebo 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%

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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