Phase I study of a Prostaglandin Ocular Implant for treatment of Open Angle Glaucoma
Not Applicable
Completed
- Conditions
- Open Angle GlaucomaEye - Diseases / disorders of the eye
- Registration Number
- ACTRN12618001026213
- Lead Sponsor
- PolyActiva Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
Open Angle Glaucoma classified as grade 3 or 4 on the modified Shaffer-Etienne Scale
A pseudophakic intent to treat eye
At least one eye with irreversible sight of Snellen 6/60 or worse
Currently administering combination eye drop therapy for open angle glaucoma
Exclusion Criteria
Intraocular surgery or cornea/refractive surgery within past 6 months
Participants with current uveitis, cystoid macular oedema, cornea oedema or retinal detachment
Current Aphakic eyes
Significant corneal guttatae
Only one eye
Uncontrolled infection of the eye
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of PA5108 ocular implant in adults with Open Angle Glaucoma. Assessments are undertaken by a qualified ophthalmologist and include standard ophthalmic assessments for visual acuity, intraocular pressure, slit-lamp biomicroscopy and gonioscopy. [Patients are assessed until the ocular implant has completely biodegraded. It is anticipated that the implant will completely degrade no sooner than 20 weeks and no later than 12 months after the date of administration.]
- Secondary Outcome Measures
Name Time Method Assess by examination with slit-lamp biomicroscopy and gonioscopy for the presence of the Pa5108 ocular implant to determine the period required for complete biodegradation.[Assessed at 4 weeks, 3, 4.5, 6, 9 and 12 months until the implant has completely degraded]