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: 100000004853; 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-CZ
• Lead Sponsor: Allergan Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-30
• Last Update Posted: 22 November 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 (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. Patient is willing to withhold his/her IOP treatments according to the study requirements, and in the opinion of the investigator, can do so without significant risk. Note: If patients cannot discontinue their currently prescribed therapy for up to 6 weeks to meet the Washout period for study entry., the investigator may switch the patient's medication to one that requires a shorter washout interval during the washout of the original medication (see Section 8.2 and Table 6 in the protocol)
4. Patient has the ability to understand and the willingness to follow study instructions and requirements and is likely to complete all required visits and procedures
5. 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)
6. Negative pregnancy test at Baseline for females of childbearing potential

Both Eyes
7. 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;
8. In the investigator’s opinion, patient’s IOP can be adequately managed with SLT monotherapy
9. In the investigator’s opinion, patient is a suitable candidate for SLT
10. 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);
11. Central endothelial cell density by specular microscopy confirmed as being qualified by Reading Center assessment prior to beginning Washout
12. The iridocorneal angle must be independently confirmed as being qualified by 2 ophthalmologists using the following critetia: 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
13. At the Baseline visit, patient has been appropriately washed out of all IOP-lowering medications
14. At the Baseline visit (8:00 AM ± 1 hour), IOP of = 22 and = 34 mm Hg, with difference between eyes of = 5 mm Hg.
15. At the Screening and Baseline (Day -3 to -1) visits, Best-Corrected Visual Acuity (Snellen equivalent, by manifest refraction) of 20/50 or better in each eye.
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

1. Uncontrolled systemic disease
2. Females who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study (see Section 4.5.3 of the protocol)
3. Known allergy or sensitivity to the study medication or its components, any component of the delivery vehicle, or any diagnostic or surgical prep agents used during the study (eg, topical anesthetic, dilating drops, fluorescein, povidone-iodine)
4. Any condition which would preclude the patient's ability to comply with study requirements (including completion of the study)
5. Patients who have a condition or are in a situation, which, in the investigator's opinion, may put the patient at significant risk, may
confound the study results, or may interfere significantly with the patient's participation in the study
6. Concurrent or anticipated enrollment in an investigational drug or device study or participation in such a study from 2 months prior to the Baseline visit through the final study visit
7. Previous or concurrent enrollment in another Allergan Bimatoprost SR
study
8. Known history of bleeding disorder or prolonged bleeding after surgery (in the opinion of the investigator). Note: Patients receiving pharmacologic blood thinners (eg, aspirin, Coumadin) may be enrolled at
the investigator's discretion.

Ocular Exclusion Criteria for Both Eyes:
9. History of previous laser trabeculoplasty
10. History or evidence of clinically relevant, substantial ocular trauma (eg, a traumatic cataract, traumatic angle recession, etc)
11. 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
12. Intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the 6 months prior to treatment (Day 1)
13. Any history of corneal graft, including partial grafts (eg, Descemet's Stripping Endothelial Keratoplasty [DSEK], Descemet's Membrane Endothelial Keratoplasty [DMEK]); or incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions
14. Corneal or other ocular abnormalities that would preclude accurate readings with an applanation tonometer, anterior segment-optical coherence tomography, specular microscope, and/or a contact
pachymeter, or could confound study results, eg, moderate to severe corneal dystrophy, including Anterior Basement Membrane Disease (ABMD; ie, Map-Dot-Fingerprint [MDF]) and guttata. Mild ABMD or mild
guttata are not exclusionary by clinical examination if, in the opinion of the investigator, the condition is stable and not likely to cause corneal changes during the
course of the study.
15. Active or recurrent ocular disease (eg, uveitis, ocular infection, chronic moderate to severe blepharitis or severe dry eye, severe ocular seasonal allergies) or sight threatening diseases (eg, neovascular agerelated
macular degeneration [ARMD], diabetic macular edema) that, in the opinion of the investigator, would put the patient at a significant risk or would interfere with t

Study & Design

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