A clinical trial to study the intraocular pressure lowering effect of an anti-glaucoma drug, LUMIGAN® (bimatoprost ophthalmic solution) 0.03%, in treating subjects who are new to treatment compared to subjects who are on prostaglandin only treatment

An Open-Label, Single Center Study of the Intraocular Pressure Lowering Effect of LUMIGAN® (Bimatoprost Ophthalmic Solution) 0.03% in Treatment Naïve Subjects Compared to Subjects on Prostaglandin Monotherapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/091/000204

Enrollment

Registered

2011-02-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: bimatoprost: 0.03%, One drop per day Control Intervention1: None: None

Eligibility

Inclusion criteria

Inclusion criteria: A. Male or female 21 years of age or greater. B. Diagnosis of mild open angle glaucoma. C. IOP must meet the following criteria for "study eye" in both eyes: between 22 and 34 mmHg inclusive at the set time measurement at Visit 2 with < or = 5 mm Hg difference between the eyes. D. Corrected visual acuity in each eye of + 1.0 log MAR or better by ETDRS in each eye (equivalent to 20/200 or better).

Exclusion criteria

Exclusion criteria: A. Known allergy, hypersensitivity, or intolerance to study medication or its components or to topical anesthetics. B. Previous glaucoma intraocular surgery in either eye. This does not include previous laser surgery. C. Known lack of ocular hypotensive response to topical ophthalmic prostaglandin analogs or prostamides (in the opinion of the investigator). D. Refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.) in either eye. E. Other forms of primary (e.g., angle closure, congenital) or secondary glaucoma other than those noted in the Inclusion Criteria.

Design outcomes

Primary

Measure	Time frame
The mean change between baseline IOP measurement at a set time point at Visit 2 and the IOP measurement at a set time point at Visit 3 through Visit 10.Timepoint: Set time at visits 2 through 10	—

Secondary

Measure	Time frame
NoneTimepoint: None	—

Countries

India

Contacts

Public ContactRanganath R. Raja

Johnson & Johnson

rraja@its.jnj.com(044) 2254 2416

Outcome results