EUCTR2015-003631-34-CZActive, not recruitingPhase 1
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients with Open-Angle Glaucoma or Ocular Hypertension
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Allergan Limited
- Enrollment
- 160
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
- •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
Investigators
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