Randomized, open-label, two parallel group clinical trial, conducted under blinding evaluator conditions to compare the efficacy and tolerability of preservative-free formulation of Latanoprost 50µg/ml eye drops vs. Xalatan in patients with open-angle glaucoma or hypertension ocular.
- Conditions
- Open Angle Glaucoma or Ocular HypertensionTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2015-005314-29-ES
- Lead Sponsor
- OMNIVISION GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Patients being
-male or female, of any race and ?18 years of age
-diagnosed of unilateral or bilateral primary open angle glaucoma or ocular hypertension
-on treatment with an IOP-lowering prostaglandin analogue for at least 6 months
-on treatment with an IOP ?21 mmHg measured as the mean of both eyes at two measurements at least one hour apart
-best-corrected visual acuity ?20 of 100 corresponding to logMAR of 0.7 in both eyes
-in case of women, postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or on use of effective birth control measures
-expected by the investigator that IOP would remain controlled with the new treatment without optic nerve damage or progression of visual field loss
-able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits;
-willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed.
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 126
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-a history of chronic or recurrent inflammatory eye disease, ocular trauma or infections;
-clinically significant or progressive retinal disease;
-intraocular surgery within the past 6 months;
-ocular laser surgery within the past 3 months;
-a change in glaucoma therapy within 1 month before the screening visit;
-history of bronchial asthma, or severe chronic obstructive pulmonary disease; reactive airway disease including bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease.
-treatment with local or systemic corticosteroids;
-inability to discontinue the use of glucocorticoid medications;
-not receiving stable doses of any medication that could affect IOP for 30 days before the beginning of the clinical trial (e.g. clonidine);
-a history of allergic hypersensitivity or poor tolerance to any component of the eye drop solution used in this clinical trial or a contraindication of ß-adrenergic receptor antagonists due to systemic disease;
-sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure or cardiogenic shock;
-pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control;
-current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s);
-unwillingness or inability to comply with the clinical trial procedures;
-unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons;
-who are legally incapacitated,
-who are legally detained in an official institute.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: It is the objective of the clinical trial to confirm the clinical non-inferiority of the preservative-free latanoprost eye drops compared with the marketed preservative-containing Xalatan? by the average decrease of diurnal IOP measured between the first and last visit;Secondary Objective: -The average decreases of diurnal IOP measured between baseline and day 7 <br>-The average decrease of diurnal IOP between baseline and day14 <br>-The proportion of patients with measured IOP <21 mmHg at the end of the clinical trial;Primary end point(s): - Diurnal IOP measured by ocular tonometry (Goldmann Applanation Tonometry) between baseline and the last visit;Timepoint(s) of evaluation of this end point: First and last visit (At Day 0 and Day 28)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Diurnal IOP measured by ocular tonometry (Goldmann Applanation Tonometry) between baseline and day 7 <br>-Diurnal IOP measured by ocular tonometry (Goldmann Applanation Tonometry) between baseline and day14 <br>-The proportion of patients with measured IOP <21 mmHg at the end of the clinical trial;Timepoint(s) of evaluation of this end point: Day 7 and day 14