Clinical Study of the safety and efficacy of Bimotoprost 0.03%/Timolol 0.5% Preservative-free Ophthalmic Solution compared with GANFORT®(Bimotoprost 0.03%/Timolol 0.5% Ophthalmic Solution) once daily for 12 weeks in Patients with Glaucoma or Ocular Hypertension.

• Conditions: Glaucoma or Ocular Hypertension; MedDRA version: 14.0Level: LLTClassification code 10008833Term: Chronic angle-closure glaucomaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]; MedDRA version: 14.0Level: LLTClassification code 10009034Term: Chronic open angle glaucomaSystem Organ Class: 10015919 - Eye disorders

• Registration Number: EUCTR2010-021507-24-DE
• Lead Sponsor: Allergan Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-13
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Male or female, 18 years of age or older and with legal age of consent.
2. Written informed consent has been obtained.
3. Written data protection consent has been obtained.
4. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable.
5. Good general health, as determined by the investigator from medical history, physical examination finding, fasting blood analysis (hematology, blood chemistry), and urinalysis, that are within reference range or acceptable to the investigator. Patients may have laboratory tests repeated once for re-screening at the discretion of the investigator.
6. Baseline: A negative urine pregnancy test result for females of childbearing potential. A female is considered to be of non-childbearing potential if she is postmenopausal (with no menses for 12 consecutive months) or without a uterus.
7. Patient is able and willing to follow study instructions and likely to complete all required visits.
8. Patient has ocular hypertension, chronic open-angle glaucoma, chronic-angle closure glaucoma with patent iridotomy/iridectomy, pseudoexfoliative glaucoma, or pigmentary glaucoma in both eyes.
9. Patient can go without IOP-lowering therapy for 4 days to 4 weeks, without significant risk to the patient.
10. Patient requires bilateral IOP-lowering therapy
11. Hour 0 of screening: Patient has been on current medication for at least 1 month or is treatment naive.
12. Hour 0 and hour 2 of screening: Approximately 12 to 14 hours after the last installation of any current medication, patient had been on treatment considered to be ineffective (IOP > 18 mm Hg in at least 1 eye) for at least 1 month OR treatment naive (IOP > 24 mm Hg in at least 1 eye). Qualifying hour 0 and hour 2 IOPs must have been from the same eye.
13. Hour 0 of baseline: best-corrected visual acuity (BCVA) score equivalent to a Snellen acuity of 20/100 or better in each eye, using a logarithmic visual acuity chart.
14. Hour 0 of baseline: IOP of = 22 mm Hg and = 30 mm Hg in each eye and asymmetry of IOP not greater than 3 mm Hg between the eyes
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 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1. Uncontrolled systemic disease.
2. Female patients who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential and not using a reliable means of contraception throughout the study.
3. Clinically relevant low or high blood pressure or pulse rate for age as determined by the investigator.
4. Patient has a condition or is in a situation that, 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.
5. Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure or cardiogenic shock or uncontrolled congestive heart failure.
6. Known allergy or contraindication to use of fluorescein.
7. Known allergy or sensitivity to the study medications or their components.
8. Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days prior to baseline or anticipated use within 21 days prior to a follow-up study visit, or topical ophthalmic corticosteroids from 2 months prior to the screening visit through the final study visit.
9. Current enrollment in an investigational drug or device study or participation in such a study at or past the screening visit, or within 30 days prior to the baseline/day -1 visit.
10. Corneal or other ocular abnormalities that would preclude accurate readings with an applanation tonometer (eg, refractive surgery, corneal graft, moderate to severe endothelial corneal dystrophy).
11. Contraindication to pupil dilation.
12. Central corneal thickness of greater than 600 micrometers or less than 500 micrometers in either eye at screening.
13. Introduction or anticipated alteration of existing chronic systemic medications (topical or injection) that may have a substantial effect on IOP (eg, systemic betablockers) from 2 months prior to screening visit through the final study visit.
14. Active or recurrent ocular disease (eg, uveitis, ocular infection, chronic moderate to severe blepharitis or severe dry eye, ocular seasonal allergies) that would interfere with the interpretation of the study data in either eye. NOTE: patients with chronic mild blepharitis, cataract, age-related macular degeneration, or a background diabetic retinopathy can be enrolled at the discretion of the investigator.
15. History (within 6 months prior to baseline) of any ocular anterior segment laser or other intraocular surgery in either eye.
16. History or evidence of severe ocular trauma in either eye.
17. History of ocular neoplasia, uveitis, or herpetic ocular diseases.
18. Required chronic use of other ocular medications (post-screening visit) during the study. NOTE: occasional use of artificial tear products is allowed but not within
24 hours prior to a scheduled visit.
19. Visual field loss that in the opinion of the investigator is functionally significant, or evidence of progressive visual field loss within the year prior to baseline (day -1).
20. In either eye, anticipated wearing of contact lenses during the study (use of soft lenses should be discontinued at least 24 hours prior to baseline, and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to baseline).
21. Patient’s IOP was previously uncontrolled on bimatoprost monotherapy.
22. Hour 0 of baseline

Study & Design

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