A Trial of the Safety and Therapeutic Effects of ILYX-002 Versus Vehicle Control for Treatment of Dry-Eye Disease in Patients with Autoimmune Disease
- Conditions
- Dry-Eye DiseaseEye - Diseases / disorders of the eye
- Registration Number
- ACTRN12623001230640
- Lead Sponsor
- Iolyx Australia Pty Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 110
1. Male or Female >=18 and <=85 years
2. History of autoimmune disease
3. BCVA of 20/100 or better in trial eye
4. Moderate to severe Dry Eye Disease
5.. Use of artificial tears at least 2 times per days for at least 30 days prior to screening
1. Known hypersensitivity or contraindications to the trial treatment or its components
2. Within 30 days prior to screening have taken contraindicated medications or investigational treatments
3. Contact lens use during the trial
4. Ocular surface or anterior segment surgery within 12 months of screening
5. Change in dose or frequency within 90 days prior to screening, or anticipated during trial, of chronic medications
6. History of uncontrolled glaucoma or actively being treated for glaucoma
7. History of punctal cautery
8. Current use of punctal plugs
9. Hepatic insufficiency
10. Currently pregnant or lactating.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method