A study to compare a slow release formulation of bimatoprost with selective laser trabeculoplasty in patients with open-angle glaucoma or high pressure in the eye

Phase 1

• Conditions: Open-angle glaucoma (OAG) or Ocular hypertension (OHT); MedDRA version: 20.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 20.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 20.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2015-003631-34-BE
• Lead Sponsor: Allergan Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-08
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Male or female, 18 years of age or older
2. Written informed consent and authorization for use and release of personal health information are obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [Unites States (US) sites] and written Data Protection consent [European Union (EU) sites])
3. In the investigator's opinion, patient's IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or non-adherence)

Ocular

1. In the investigator's opinion, both eyes can be treated adequately
with topical prostamide, prostaglandin, or prostaglandin analog (eg,
LUMIGAN, Xalatan, Travatan) eye drops as the sole therapy if medication was taken as directed
2. In the investigator's opinion, patient's IOP can be adequately
managed with SLT monotherapy
3. In the investigator's opinion, patient is a suitable candidate for SLT
4. Diagnosis of either OAG (ie, primary OAG, pseudoexfoliation
glaucoma, pigmentary glaucoma) or OHT in each eye, requiring bilateral IOP-lowering treatment. (Note: diagnosis does not have to be the same in both eyes)
5. Central endothelial cell density by specular microscopy confirmed as being qualified by Reading Center assessment prior to beginning
Washout
6. The iridocorneal angle be independently confirmed as being qualified by 2 ophthalmologists using the following criteria:
a. Shaffer Grade = 3 on clinical gonioscopy of the inferior angle
b. Peripheral anterior chamber depth by Van Herick examination = 1/2 corneal thickness
Note: The independent eligibility assessments must both agree that the Shaffer grade is = 3 and the Van Herick grade is = 1/2 corneal thickness.
7. At the Baseline visit (8:00 AM ± 1 hour), IOP of = 22 and = 34 mm Hg, with difference between eyes of = 5 mm Hg
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Ocular
1. History of previous laser trabeculoplasty

The following surgical history:

a. History or evidence of complicated cataract surgery: eg, surgery
resulting in complicated lens placement (such as anterior chamber
intraocular lens implant (IOL, sulcus IOL, aphakia, etc) or intraoperative complications (such as a posterior capsular tear [with or without vitreous loss], substantial iris trauma, etc). Note: history of
uncomplicated cataract surgery is not an exclusion.
b. History of phakic IOL insertion for refractive error correction

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified