EUCTR2006-000991-34-DE
Active, not recruiting
Not Applicable
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 sites120 target enrollmentMarch 6, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients suffering from keratoconjunctivitis sicca (dry eye) and break-up-time (BUT) values < 10 sec
- Sponsor
- Dr. Gerhard Mann, Chem-pharm. Fabrik GmbH
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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