None listed
Conditions
Interventions
Bimatoprost SR (Sustained release)* 10 μ
g and 15 ug
(*This is a formulation of bimatoprost into a sustained-released implant which is preloaded in an applicator for administration).
Sham administration (needleless applicator)
Timol
g and 15 μ
g
Control: Timolol eye drops plus Sham needleless procedure (that involves touching the eye at the area of insertion with a needleless applicator).
Dosage/Dose Regimen: Patients will receive one
placebo eye-drops will be applied BID on the study eye of patients receiving study treatment.
The fellow eye for all groups will be treated with Sham administration procedure (day 1, Week 16 and We
Sponsors
Allergan, Inc.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, ≥ 18 years. 2. Informed consent. 3. Written documentation has been obtained in accordance with the relevant country and local privacy requirements. 4. Patient is willing to withhold his/her IOP-lowering treatments. 5. Patient has the ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures. 6. A negative pregnancy test result. 7. Diagnosis of either OAG or OHT. 8. Either eye can be treated adequately with timolol. 9. The iridocorneal angle inferiorly must be open based on clinical gonioscopic examination. 10. Iridocorneal angle in the study eye must be confirmed as being qualified by AS-OCT assessment. 11. Patient is a responder to IOP lowering by topical prostamides, prostaglandins, or prostaglandin analogs. 12. Baseline visit: patient has been appropriately washed out of all IOP-lowering Medications 13. Baseline visit: a. Hour 0 IOP in both eyes of ≥ 22 mm Hg and ≤ 32 mm Hg, with difference between eyes of ≤ 5 mm Hg b. Hour 2 IOP in both eyes of ≥ 19 mm Hg and ≤ 32 mm Hg 14. Central Corneal Endothelial Cell Density by specular microscopy: a. Screening, a minimum density of 2000 cells/mm2 in at least one eye by automated analysis b. Baseline: final central density in both eyes must be confirmed. 15. Screening and Baseline visit: BCVA of 20/40 or better in the study eye and 20/80 or better in the fellow eye.
Exclusion criteria
Exclusion criteria: Non-ocular Criteria 1. Uncontrolled systemic disease 2. Female patients who are pregnant or nursing. 3. Known allergy or sensitivity to the study medication or its components 4. Contraindications to beta-blocker therapy 8. Anticipated use of oral, intramuscular, or intravenous (IV) corticosteroids. 11. Known history of bleeding disorder or prolonged bleeding after surgery Ocular Criteria 12. Patient is nonresponsive to topical ophthalmic beta-blockers 13. History of a traumatic cataract and/or angle recession in either eye 14. History of cataract surgery in the study eye resulting in anterior chamber intraocular lens implant (IOL). 15. Intraocular surgery and/or any ocular laser surgery 16. Any history of corneal graft, including partial grafts. 17. Incisional refractive surgery. 18. Corneal or other ocular abnormalities. 19. Any history of iris color changes associated with use of topical prostaglandins or prostamides in either eye 20. Active or recurrent ocular disease in either eye. 21. History of ocular neoplasia or herpetic ocular diseases. 23. History of moderate or worse (≥ +2) bulbar conjunctival hyperemia due to prostaglandin, prostamide, or prostaglandin analog use in either eye 24. The following anticipated wearing of contact lenses during the study. 25. Central corneal thickness of 620 micrometers in the study eye 26. Anticipated need for any incisional or laser ocular surgery in either eye Para mayor informacion dirigirse al protocolo.
Countries
Austria, Belgium, Brazil, Chile, Denmark, France, Germany, Hungary, Israel, Peru, Philippines, Poland, Spain, Switzerland, Taiwan, United States
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed