A 12-week randomised, evaluator-masked, parallel-group, multinational, multi-centre study comparing the efficacy and safety of the fixed combination of latanoprost and timolol (XalacomTM) with the fixed combination of dorzolamide and timolol (Cosopt®) in subjects with open-angle glaucoma or ocular hypertension.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-001128-35-DE
• Date of registration: 11/05/2005
• Prospective Registration: Yes
• Primary sponsor: Pfizer Pharma GmbH
• Public title: A 12-week randomised, evaluator-masked, parallel-group, multinational, multi-centre study comparing the efficacy and safety of the fixed combination of latanoprost and timolol (XalacomTM) with the fixed combination of dorzolamide and timolol (Cosopt®) in subjects with open-angle glaucoma or ocular hypertension.
• Scientific title: A 12-week randomised, evaluator-masked, parallel-group, multinational, multi-centre study comparing the efficacy and safety of the fixed combination of latanoprost and timolol (XalacomTM) with the fixed combination of dorzolamide and timolol (Cosopt®) in subjects with open-angle glaucoma or ocular hypertension.
• Date of first enrolment: 02/06/2005
• Target sample size: 238
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001128-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Germany, Italy, Sweden

Key inclusion & exclusion 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 <37 mmHg in at least one eye.
4. At the baseline/randomization visit, subjects should have a mean IOP of the 8 AM, 12 PM and 4 PM measurements of between more than or equal to 24 mmHg and <37 mmHg in at least one eye in order to be included in the study.
5. Visual acuity correctable to 20/200 or better by Snellen acuity measurement in each eye.
6. Able to adhere to treatment/visit plan.
7. Subjects highly motivated to complete all study visits and capable of understanding and having signed an informed consent after full discussion of the research nature of the treatment including its risks and benefits.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

open angle glaucoma
MedDRA version: 7.1 Level: LLT Classification code 10030348

Intervention(s)

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
Concentration number: 50-
INN or Proposed INN: timolol maleate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.8-

Trade Name: Cosopt
Product Name: Cosopt
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: dorzolamide hydrochloride
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 22.26-
INN or Proposed INN: timolol maleate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.83-

Primary Outcome(s)

Primary end point(s): intra ocular pressure

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.

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 ID(s)

A6641038