Patients suffering from keratoconjunctivitis sicca (dry eye) and break-up-time (BUT) values < 10 sec
Conditions
Interventions
Trade Name: Vitagel
Pharmaceutical Form: Eye gel
INN or Proposed INN: retinol palmitate
CAS Number: 79-81-2
Concentration unit: IU/g international unit(s)/gram
Concentration type: equal
Concentration
Sponsors
Dr. Gerhard Mann, Chem-pharm. Fabrik GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients with keratoconjunctivitis sicca and BUT =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to investigate the tolerability of Vitagel in comparison to Liposic after repeated ocular applications over 12 months in patients with keratoconjunctivitis sicca as requested by the competent authority (BfArM) Primary objective Subjective assessment of tolerability (sum score of itching, burning and discomfort) at the 6 ± 1 week assessment time point, comparison between treatment groups (non-inferiority);Secondary Objective: Secondary objectives Subjective assessment of tolerability (sum score of itching, burning and discomfort) 14 ± 2 days, 16 ± 2 weeks, 32 ± 2 weeks and 12 months ± 2 weeks after start of treatment, comparison between treatment groups (non-inferiority) Signs for irritation (corneal stipples, chemosis and injection) at all assessment time points, comparison between treatment groups (non-inferiority) Subjective assessment of keratoconjunctivitis sicca by patients (dryness, sand grain feeling, burning, itching and pain) at all assessment time points, comparison between treatment groups (non-inferiority) Break-up-time (BUT) at all assessment time points, comparison between treatment groups (non-inferiority) Assessment of blurred vision at each assessment time point· Safety parameters;Primary end point(s): Primary endpoint: Tolerability Sum Score (itching, burning, discomfort) after six weeks of product application: Analysis of non-inferiority of Vitagel® with respect to Liposic® | — |
Countries
Germany
Outcome results
None listed