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: 19.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 19.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 19.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2015-003631-34-ES
• 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 June 2020

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 (e.g., Written Authorization for Use and Release of Health and Research Study Information [United 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 (e.g., due to intolerance or nonadherence)

Both Eyes
1. In the investigator’s opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog (e.g., 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 (i.e., 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 inferiorly must be confirmed as being qualified by Reading Center anterior segment optical coherence tomography assessment prior to beginning Washout;
7. At the Baseline visit (8:00 AM ± 1 hour), IOP of >/= 22 and 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

Both Eyes
• History of previous laser trabeculoplasty
• History of cataract surgery resulting in anterior chamber (AC) intraocular lens (IOL) implant, phakic IOL, sulcus IOL, aphakia, or complications (e.g., a posterior capsular tear [with or without vitreous loss], iris trauma, etc.)

Study & Design

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