Lotemax in the treatment of chronic anterior uveitis: a pilot study

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2008
INTERVENTION: Trade Name: Lotemax Pharmaceutical Form: Eye drops, suspension Other descriptive name: Loteprednol Etabonate Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5‐ Trade Name: Maxidex Pharmaceutical Form: Eye drops, suspension Other descriptive name: Dexamethasone Concentration unit: % (W/V) percent weight/volume Concentration type: equal Concentration number: 0.1‐ Trade Name: Pred Forte Pharmaceutical Form: Eye drops* Other descriptive name: Prednisolone Acetate Concentration unit: % (W/V) percent weight/volume Concentration type: equal Concentration number: 1‐ CONDITION: Chronic Anterior Uveitis ; MedDRA version: 9.1 Level: LLT Classification code 10002709 Term: Anterior uveitis PRIMARY OUTCOME: Main Objective: Exploratory study to examine whether Lotemax can be used for the management of patients with chronic anterior uveitis Primary end point(s): 1. Inflammation as quantified by laser flare meter and flare readings; 2. Intraocular pressure as measured with Goldmann applanation tonometry; 3. Recruitment rates; 4. Drop‐outs Secondary Objective: To assess safety measures associated with the use of topical steroids.; To assess the control of inflammation without inducing an increase in intraocular pressure INCLUSION CRITERIA: 1. Patients 18 ‐ 75 years with a clinical diagnosis of chronic anterior uveitis, who require long‐term use of steroids 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) yes F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 5be9ed534420517ad7709387e95725bf113fe198
First added on: Aug 21, 2024