EUCTR2011-005339-15-ESActive, not recruitingNot Applicable
Open, Observer-blind, two Parallel Group, Randomized, Multicentric Clinical Phase III Trial on the Comparison of Efficacy and Tolerability of a New Preservative-free Formulation of the Fixed Combination Latanoprost 50 µg/ml and Timolol 5 mg/ml Eye Drops vs. Xalacom? Eye Drops in Patients with Primary Open Angle Glaucoma or Ocular Hypertension - QTM/OMN0211
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Omnivision GmbH
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-male or female, of any race and ?18 years of age;
- •-diagnosed of unilateral or bilateral primary open angle glaucoma or ocular hypertension;
- •-on treatment with an IOP-lowering prostaglandin analogue/beta blocker combination for at least 6 months;
- •-on treatment with an IOP ?21 mmHg measured as the mean of both eyes at two measurements at least one hour apart;
- •-best-corrected visual acuity ?20 of 100 corresponding to logMAR of 0.7 in both eyes;
- •-in case of women, postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or on use of effective birth control measures;
- •-expected by the investigator that IOP would remain controlled with the new treatment without optic nerve damage or progression of visual field loss;
- •-able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits;
- •-willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed.
- •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 170
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •-pre-treatment for primary open angle glaucoma or intraocular hypertension other than prostaglandin analogue/beta blocker combinations;
- •-a history of chronic or recurrent inflammatory eye disease, ocular trauma or infections;
- •-narrow-angle/angle-closure glaucoma;
- •-clinically significant or progressive retinal disease;
- •-intraocular surgery within the past 6 months;
- •-ocular laser surgery within the past 3 months;
- •-a change in glaucoma therapy within 1 month before the screening visit;
- •-best-corrected visual acuity worse than 0.7 logarithm of minimal angle of resolution (logMAR) score, extremely narrow or partially closed angle, cup/disk ratio >0.8;
- •-history of bronchial asthma, or severe chronic obstructive pulmonary disease; reactive airway disease including bronchial asthma,
- •-treatment with local or systemic corticosteroids;
- •-inability to discontinue the use of glucocorticoid medications;
- •-not receiving stable doses of any medication that could affect IOP for 30 days before the beginning of the clinical trial (e.g. clonidine);
- •-a history of allergic hypersensitivity or poor tolerance to any component of the eye drop solution used in this clinical trial or a contraindication of ß-adrenergic receptor antagonists due to systemic disease;
- •-sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure or cardiogenic shock;
- •-pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control;
- •-current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s);
- •-unwillingness or inability to comply with the clinical trial procedures;
- •-unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons;
- •-who are legally incapacitated,
- •-who are legally detained in an official institute.
Investigators
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