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.

• Conditions: Patients suffering from keratoconjunctivitis sicca (dry eye) and break-up-time (BUT) values < 10 sec

• Registration Number: EUCTR2006-000991-34-DE
• Lead Sponsor: Dr. Gerhard Mann, Chem-pharm. Fabrik GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified