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

ISRCTN	ISRCTN80385690
DOI	https://doi.org/10.1186/ISRCTN80385690
EudraCT/CTIS number	2008-002122-10
Secondary identifying numbers	RDR 342; EudrCT-Number: 2008-002122-10

Submission date: 29/10/2010
Registration date: 01/11/2010
Last edited: 11/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr Gunther Kahle
Scientific

Kurfürstendamm Nr 69
Berlin
10707
Germany

Study information

Study design	Prospective multicentre two arm randomised investigator blind parallel group clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Comparison of the Clinical Efficacy and Tolerability of Latanoprost RDR 0.005% Eye Drops Test Formulation of RDR Pharma GmbH, Germany, for the Treatment of Ocular Hypertension and Primary Open Angle Glaucoma with Xalatan® 0.005% Eye Drops: A multicenter, randomized, investigator-blind clinical trial with parallel groups
Study acronym	RDR 342
Study hypothesis	The study drug is tested for non-inferiority in comparison to Xalatan®
Ethics approval(s)	The Ethics Committee of the State of Berlin, State Office of Health and Welfare (Ethik-Kommission des Landes Berlin, Landesamt für Gesundheit und Soziales [LAGeSo]) approved on the 17th of October 2008 (ref: ZS EK 14 280/08)
Condition	Ocular Hypertension; Primary Open Angle Glaucoma
Intervention	Test Drug: Latanoprost 0.005% RDR Eye Drops Reference Drug: Xalatan® 0.005% Eye Drops Patients are randomised to receive either the test drug or the reference drug. Dose, duration, frequency and mode of application is the same for both: Dose: 1 drop Duration: 42 days Frequency: once a day Mode of application: The drug is to be dropped into the affected eye(s) Possible Interim Drugs (for patients treated with prostaglandins or betablockers at baseline, undergoing a 4 week washout period) Dorzolamide-containing eye-drops (20 mg/ml), or Pilocarpine-containing eye-drops (20 mg/ml) The interim drug may be described by the Investigator for a period of three weeks. The interim drug should be stopped one week or 3 days, respectively, before the baseline investigation and start of study medication. For either medication: Dose: 1 drop Frequency: 3 times a day Duration of the study is up to 10 weeks for subjects (6 weeks treatment, + 4 weeks wash out phase only if necessary), with 4 visits including initial screening/consenting visit.
Intervention type	Other
Primary outcome measure	Intra-ocular pressure: Mean change of the 8 am IOP from baseline value to end of study value measured on the study eye
Secondary outcome measures	1. Efficacy 1.1. Mean change of the 8am IOP from baseline value to visit 2 1.2. Mean change of the 12noon and 4pm IOP from baseline value to visit 2 and to end of study value 2. Safety 2.1. Adverse Events 2.2. Subjective tolerance 2.3. Ophthalmologic examinations 2.4. Vital signs
Overall study start date	25/05/2009
Overall study end date	10/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	260
Participant 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
Participant 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
Recruitment start date	25/05/2009
Recruitment end date	10/12/2009

Locations

Countries of recruitment

Bulgaria
Germany
Latvia
Poland

Study participating centre

Kurfürstendamm Nr 69

Berlin
10707
Germany

Sponsor information

RDR Pharma GmbH (Germany)
Industry

Frohmestraße 78d
Hamburg
22459
Germany

Funders

Funder type

Industry

Bausch & Lomb GmbH (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan