A randomized, double-blind, monocentric phase IV clinical study on the ocular tolerability of a topical ophthalmic product containing Retinolpalmitat 1000 I.U. in comparison to a reference product containing Carbomer 0.2 % with repeated ocular applications over 12 months in 120 patients with keratoconjunctivitis sicca - ocular tolerability of a topical ophthalmic product containing Retinolpalmitat 1000 I.U.

Dr. Gerhard Mann, Chem-pharm. Fabrik GmbH0 个研究点目标入组 120 人开始时间: 2006年3月6日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Male and female patients with keratoconjunctivitis sicca and BUT < 10 sec.
•Age 18 to 70
•willingness to actively participate in the study and to come to the scheduled visits
•willingness to adhere to the study procedures
•signed written informed consent to participate in the study
•negative urine pregnancy test (in female patients of child bearing potential)
•for female patients of childbearing potential: signed written confirmation to use safe contraception (hormonal contraceptive method, condom with spermicidal agent, IUD, diaphragm combined with spermicidal creams, sterilized partner, sexual abstinence)
•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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•any active ophthalmologic disease other than keratoconjunctivitis sicca
•patients using currently (at screening) ophthalmic medications
•artificial tear products 7 days prior to the start of the study and 7 days prior to the screening
•known allergy against peanuts or soy beans
•acute ocular infection and/or inflammation within one month prior to the start of the study
•patients who had ocular surgery within the last 6 months prior to the start of the study
•patients with a history of recurrent inflammatory diseases of the eyes
•patients wearing contact lenses
•pregnancy or lactation
•severe illness on account of which the patient should not participate in the study in the opinion of the investigator
•known incompatibility or allergy against the test or reference product
•psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing
•any history of drug addiction or alcoholism in the past 3 years
•infectious diseases (e.g. hepatitis or AIDS)
•patients with poor compliance
•participation in a clinical trial within the last 30 days prior to the start of this study
•patients underlying any other restrictions due to the participation in other tests / test institutes
•employees of the study sites or of the Sponsor company
•if in the opinion of the investigator the patient should not participate in the study for any reason

发起方

Dr. Gerhard Mann, Chem-pharm. Fabrik GmbH