Condition category
Eye Diseases
Date applied
29/10/2010
Date assigned
01/11/2010
Last edited
11/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gunther Kahle

ORCID ID

Contact details

Kurfürstendamm Nr 69
Berlin
10707
Germany

Additional identifiers

EudraCT number

2008-002122-10

ClinicalTrials.gov number

Protocol/serial number

RDR 342; EudrCT-Number: 2008-002122-10

Study information

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

Acronym

RDR 342

Study hypothesis

The study drug is tested for non-inferiority in comparison to Xalatan®

Ethics approval

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)

Study design

Prospective multicentre two arm randomised investigator blind parallel group clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

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

Phase

Phase III

Drug names

Primary outcome measures

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 trial start date

25/05/2009

Overall trial end date

10/12/2009

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

260

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

Trial participating centre

Kurfürstendamm Nr 69
Berlin
10707
Germany

Sponsor information

Organisation

RDR Pharma GmbH (Germany)

Sponsor details

Frohmestraße 78d
Hamburg
22459
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Bausch & Lomb GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes