open angle glaucoma MedDRA version: 7.1 Level: LLT Classification code 10030348
Conditions
Interventions
Trade Name: Xalacom
Product Name: Xalacom™
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: latanoprost
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concent
Sponsors
Pfizer Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female at least 18 years old. 2. Unilateral or bilateral primary open angle glaucoma including pseudoexfoliative glaucoma, or ocular hypertension currently on beta blocker monotherapy or dual therapy, in which at least one medication is a beta-blocker for at least 4 weeks prior to screening. Glaucoma is defined as either visual field defects and/or glaucomatous changes of the optic nerve head. 3. At screening, subjects should be insufficiently responsive to current mono or dual therapy defined as a mean of the 8 AM measurement of between >21 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Closed/barely open anterior chamber angle or history of acute angle closure glaucoma (subjects who are diagnosed with POAG after a successful peripheral iridotomy may be enrolled). 2. History of ALT (Argon Laser Trabeculoplasty) or SLT (Selective Laser Trabeculoplasty) within 3 months prior to the baseline visit in one or both eyes (the unlasered eye may be enrolled as the study eye). 3. History of any ocular filtering surgical intervention in one or both eyes (the unfiltered eye may be enrolled as the study eye). 4. Ocular surgery (on the globe of the eye only), or inflammation within 3 months prior to baseline visit in the study eye/eyes. 5. Change in glaucoma therapy within 1 month prior to screening visit. 6. Hypersensitivity to benzalkonium chloride, or to any other component in Xalacom™, Xalatan and/or timolol, Cosopt (c) or dorzolamide eye-drop solutions. 7. Ocular infection within 3 weeks prior to the screening visit in the study eye/eyes. 8. In the investigator's clinical judgment, any other abnormal ocular condition or symptom preventing the subject from entering the study. 9. Uncontrolled systemic disease, which in the investigator’s opinion, determines the subject inappropriateness for entry into this study. Other conditions 10. Conditions in which treatment with a beta-adrenergic receptor antagonist is contraindicated, including bronchial asthma, history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia (heart rate < 60 beats per minute), second- or third-degree atrioventricular block, overt cardiac failure, or cardiogenic shock. 11. History of seriously reduced kidney function and hyperchloraemic acidosis. 12. Use of systemic medication known to affect IOP (i.e., alpha-adrenergic agonists, beta-adrenergic antagonists, calcium channel blockers, ACE inhibitors and/or angiotensin II receptor blockers, or corticosteroids), unless the subject and the medication dosage have been stable for three months prior to the screening visit and the dosage is not expected to change during the study. 13. Participation in other study involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study. Women 14. Women of childbearing potential who are not using contraceptive methods. Childbearing potential is defined as women who are not surgically sterile or are not postmenopausal (at least 12 months without a menstrual period). Contraception is defined as abstinence, having a vasectomized partner, ongoing use of an approved oral, injectable or implanted contraceptive, a barrier method, or an IUD. 15. Women of childbearing potential must have a negative pregnancy test at the screening visit, baseline visit and final visit. 16. Nursing mothers Other Therapy 17. No other topical ophthalmic medication known to affect IOP may be used during the study. In addition, systemic carbonic anhydrase inhibitors are prohibited. 18. Other therapy considered necessary for the subject's welfare may be administered at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the mean diurnal IOP reducing effect of Xalacom™ administered once daily in the evening is non-inferior to that of Cosopt administered twice daily from Baseline to Week 12.;Secondary Objective: To compare the following for the two treatment groups: the mean diurnal IOP measurements at Week 4, the mean IOP measurements at each time point (8 AM, 12 PM noon, and 4 PM) after 4 and 12 weeks of treatment, and the safety over the 12-week period.;Primary end point(s): intra ocular pressure | — |
Countries
Germany, Italy, Sweden
Outcome results
None listed