Comparative Study of the Efficacy and Safety of two presentations of Bimatoprost 0.03% available in Brazil: Glamigan(registered trademark) and Lumigan(registered trademark).

In glaucoma or ocular hypertension, have the two presentations of bimatoprost 0.03% availabe in Brazil similar safety and efficacy profile?

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000199011

Enrollment

Registered

2010-03-09

Start date

2010-05-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of the study is to compare the safety and efficacy of the two avalable presentations of bimatoprost 0.03% in Brazil. We intent to compare the reduction of the intraoclular pressure with the two deifferent presentations and observe the incidence of side effects.

Interventions

bimatoprost 0.03% eye drops: Lumigan(registered trademark) versus Glamigan(registered trademark), 45 days of treatment with each

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Ocular Hypertension: - intraocular pressure higher than 21mmHg with no medication -normal visual field test -normal optic nerve appearance Glaucoma: -intraocular pressure higher than 21mmHg with no medication -glaucomatous visual filed test -glacuomatous optic nerve appearance

Exclusion criteria

- visual acuity worse than 20/40 (Snellen scale) - intraocular pressure higher than 36mmHg with medication - diabetes -intraocular laser or surgery on the last 6 months -ocular trauma on the last 6 months

Outcome results