ISRCTN80385690
Completed
Not Applicable
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
RDR Pharma GmbH (Germany)0 sites260 target enrollmentNovember 1, 2010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ocular Hypertension
- Sponsor
- RDR Pharma GmbH (Germany)
- Enrollment
- 260
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
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 DropsOcular Hypertension (IOP>22 mmHg), Primary Open Angle Glaucoma (mean defect between 0 and -12 db in a visual field)MedDRA version: 9.1Level: LLTClassification code 10030043Term: Ocular hypertensionMedDRA version: 9.1Level: LLTClassification code 10036719Term: Primary open angle glaucomaEUCTR2008-002122-10-BGRDR Pharma GmbH300
Active, not recruiting
Not Applicable
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 groupsOcular Hypertension (IOP>22 mmHg), Primary Open Angle Glaucoma (mean defect between 0 and -12 db in a visual field)MedDRA version: 9.1Level: LLTClassification code 10030043Term: Ocular hypertensionMedDRA version: 9.1Level: LLTClassification code 10036719Term: Primary open angle glaucomaEUCTR2008-002122-10-LVRDR Pharma GmbH260
Active, not recruiting
Not Applicable
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 groupsEUCTR2008-002122-10-LTRDR Pharma GmbH260
Active, not recruiting
Not Applicable
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 groupsOcular Hypertension (IOP>22 mmHg), Primary Open Angle Glaucoma (mean defect between 0 and -12 db in a visual field)MedDRA version: 9.1Level: LLTClassification code 10030043Term: Ocular hypertensionMedDRA version: 9.1Level: LLTClassification code 10036719Term: Primary open angle glaucomaEUCTR2008-002122-10-DERDR Pharma GmbH260
Recruiting
Phase 2
effectiveness and patient tolerance of oral lavage of Rhamnus frangula extract for colonoscopy preparatioIRCT20220104053626N4Tabriz University of Medical Sciences116