A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants with Open-Angle Glaucoma or Ocular Hypertensio

Phase 1

Conditions: Open-Angle Glaucoma or Ocular Hypertension
MedDRA version: 20.0Level: LLTClassification code 10030856Term: Open-angle glaucomaSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 20.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2018-002574-52-GB

Lead Sponsor: Allergan Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 200

Inclusion Criteria

-Participant must be at least 18 years of age at the time of signing the informed consent;
-Male or female;
-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 [US sites] and written Data Protection consent [EU sites]);
-Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow up period;
-A female participant is eligible to participate if she is not pregnant (ie, has a negative urine pregnancy result at Baseline), not breastfeeding, and at least one of the following conditions applies:
a. Not a WOCBP as defined in Appendix 7 of the protocol
OR
b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 7 of the protocol during the study period
- Participant 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 participants cannot discontinue their currently prescribed therapy for up to 8 weeks to meet the Washout period for study entry, the investigator may switch the participant’s medication to one that requires a shorter washout interval during the washout of the original medication.
- Participant has the ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures
- In the investigator’s opinion, participant’s IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence)
- Diagnosis of either OAG (ie, primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT in the study eye, requiring IOP-lowering treatment;
-In the investigator’s opinion, the study eye 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;
-The iridocorneal angle in the study eye must be, in the opinion of the investigator, able to safely receive at least 1 Bimatoprost SR implant using the following criteria:
a. Shaffer Grade = 3 on clinical gonioscopy of the inferior angle
b. Peripheral anterior chamber depth by Van Herick examination = ½ corneal thickness;
-At the Baseline visit, participant has been appropriately washed out of all IOPlowering medications;
-At the Baseline visit (9:00 AM ± 1 hour), IOP of = 22 and = 34 mm Hg in the study eye;
-Central corneal endothelial cell density by specular microscopy deemed acceptable, in the opinion of the investigator (at Screening, a minimum endothelial cell density of 1800 cells/mm2 in the study eye by automated analysis);
-At the Baseline visit: BCVA (Snellen equivalent, by manifest refraction) of 20/50 or better in the study eye and 20/100 or better in the fellow 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 100

Exclusion Criteria

-Uncontrolled systemic disease;
-Females who are pregnant, nursing, or planning a pregnancy during the study OR who are WOCBP and will not follow contraceptive guidance;
-Known allergy or sensitivity to any study medication or its components, any component of the delivery vehicle, procedure-related materials, or diagnostic agents used during the study (eg, topical anesthetic, dilating drops, fluorescein, povidone-iodine);
-Participants who have a condition or are in a situation which, in the investigator’s opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant’s participation in the study;
-Concurrent or anticipated enrollment in an investigational drug or device study or participation in such a study within 2 months prior to the Baseline visit through the final study visit;
-Concurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received. Participants enrolled in the 192024- 091/092 studies who were randomized to the control treatment and never received an implant may be considered for enrollment at the investigator’s discretion.
-Known history of bleeding disorder or prolonged bleeding after surgery (in the opinion of the investigator)
Note: Participants receiving pharmacologic blood thinners (eg, aspirin, Coumadin) may be enrolled at the investigator’s discretion;
-History of previous laser trabeculoplasty in the study eye;
-History or evidence of clinically relevant, substantial ocular trauma (eg, a traumatic cataract, traumatic angle recession, etc.) in the study eye;
-The following surgical history in the study eye:
a. History or evidence of complicated cataract/lens 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;
-Intraocular surgery (including cataract surgery) in the study eye within the 6 months prior to treatment administration (Day 1 Cycle 1 Administration);
-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 in the study eye;
-Central corneal thickness of < 480 or > 620 micrometers in the study eye;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the duration of IOP-lowering effect of Bimatoprost SR in participants with OAG or OHT who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence).;Secondary Objective: To evaluate the safety of Bimatoprost SR in participants with OAG or OHT who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence).;Primary end point(s): Duration of effect of Bimatoprost SR;Timepoint(s) of evaluation of this end point: at each study visit starting baseline

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Adverse events; visual fields; visual acuity; macroscopic bulbar conjunctival hyperemia; slit-lamp biomicroscopic assessments; dilated ophthalmoscopic assessments (including optic disc assessment); contact ultrasound pachymetry; gonioscopy; specular microscopy;Timepoint(s) of evaluation of this end point: at each study visit

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