Comparison of the Clinical Efficacy and Tolerability of Latanoprost RDR Eye Drops vs. Xalatan® Eye Drops for the Treatment of Ocular Hypertension and Primary Open Angle Glaucoma

Completed

• Conditions: Ocular Hypertension; Primary Open Angle Glaucoma; Eye Diseases; Glaucoma

• Registration Number: ISRCTN80385690
• Lead Sponsor: RDR Pharma GmbH (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-01
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. Unilateral or bilateral ocular hypertension or primary open angle glaucoma at an early stage
2. In at least one eye, IOP = 22 mmHg at 8am and IOP = 30 mmHg at 8 am, 12 noon and 4 pm under the following conditions:
2.1. untreated ocular hypertension, or
2.2. 4 week washout period of an initial monotherapy with a prostaglandin or beta-blocker
3. Best corrected visual acuity = 20/100 (Snellen) or 2/10 (Monoyer)
4. Male and female patients, age = 18 years
5. Female subjects of childbearing age must be using a medically accepted form of birth control and must have a negative urine pregnancy test at screening
6. Able to provide informed consent after risks and benefits of the study have been explained
7. Ability to communicate effectively with study personnel
8. Written informed consent

Exclusion Criteria

1. In both eyes, IOP < 22 mmHg
2. IOP > 30 mmHg
3. Known sensitivity to latanoprost or any component of the drug products
4. Use of contact lenses
5. Other defined ocular diseases, ocular interventions, or ocular medications
6. Pregnancy or breastfeeding
7. Other defined diseases such as dysfunction of the liver or the kidneys, cancer, angina pectoris, asthma bronchiale, haematological diseases
8. Current or anamnestic drug addiction or extensive alcohol use
9. Participation in another clinical study within 4 weeks prior to enrolment
10. History of non-compliance
11. Any condition that compromises the ability to understand or comply with study requirements
12. Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intra-ocular pressure:<br>Mean change of the 8 am IOP from baseline value to end of study value measured on the study eye

Secondary Outcome Measures

Name	Time	Method
1. Efficacy <br>1.1. Mean change of the 8am IOP from baseline value to visit 2 <br>1.2. Mean change of the 12noon and 4pm IOP from baseline value to visit 2 and to end of study value <br><br>2. Safety<br>2.1. Adverse Events <br>2.2. Subjective tolerance <br>2.3. Ophthalmologic examinations<br>2.4. Vital signs