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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-003689-24-GB

Enrollment

Registered

2008-07-16

Start date

2009-04-29

Completion date

Unknown

Last updated

2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Anterior Uveitis MedDRA version: 9.1 Level: LLT Classification code 10002709 Term: Anterior uveitis

Interventions

Trade Name: Lotemax Pharmaceutical Form: Eye drops, suspension Other descriptive name: Loteprednol Etabonate Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration n

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Patients with known sensitivity to the study medications 2. Pregnant or lactating women 3. Women of childbearing potential, unless using adequate birth control and test negative for pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: Exploratory study to examine whether Lotemax can be used for the management of patients with chronic anterior uveitis;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;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	—

Measure

Time frame

Main Objective: Exploratory study to examine whether Lotemax can be used for the management of patients with chronic anterior uveitis;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;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

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026