Primary open-angle glaucoma, Ocular hypertension, Pseudoexfoliation glaucoma or Pigment dispersion
Conditions
Interventions
Trade Name: LUMIGAN®
Product Name: LUMIGAN®
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: Bimatoprost
Current Sponsor code: SPON UWCM 014
Concentration unit: mg/ml milligram(s)/milli
Sponsors
CARDIFF UNIVERSITY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult subjects diagnosed with Primary open angle Glaucoma, Ocular hypertension, Pseudoexfoliation glaucoma & Pigment dispersion with IOP between 21mm of Hg and 36mm of Hg.The angle of anterior chamber should be more than Grade II (Shaffer's grading). Patients will not have received any prior treatment for glaucoma or ocular hypertension. Patients willing and able to make required study visits. Informed consent read, signed and dated by the subject before being included in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Females of childbearing potential are excluded if they are pregnant or intend to become pregnant during the study period or are breast feeding. Any intraocular recurrent inflammatory eye disease (i.e., scleritis, uveitis, herpes keratitis) History of trauma or any intraocular or refractive surgery or any form of laser surgery involving the eye will be excluded from the study. Any abnormality preventing reliable applanation tonometry of the eye. History of severe or serious hypersensitivity to prostaglandins, prostamides or prostaglandin analogues. Any other form of secondary glaucoma or secondary ocular hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To measure the relative efficacy in lowering of intraocular pressure of Bimatoprost vs Latanoprost in subjects suffering from Primary Open Angle Glaucoma, Ocular Hypertension, Pseudoexfoliation glaucoma & Pigment dispersion. ;Secondary Objective: To investigate the reduction of intraocular pressure with other ocular parameters viz. axial length, central corneal thickness etc. ;Primary end point(s): Lowering of intraocular pressure (IOP) from baseline after first & second medication & any significant difference between the same. | — |
Countries
United Kingdom
Outcome results
None listed