Status:
COMPLETED
Alcon® Ex-PRESS® Glaucoma Filtration Device in Japanese Patients
Lead Sponsor:
Alcon Research
Conditions:
Glaucoma
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the efficacy and safety of the Alcon Ex-PRESS® Glaucoma Filtration Device (Ex-PRESS) in Japanese subjects with normal tension glaucoma.
Eligibility Criteria
Inclusion
- Diagnosis of normal tension glaucoma.
- Indicated for filtration surgery using Ex-PRESS®.
- Understand and provide Informed Consent.
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Women who are pregnant, lactating, or planning to be pregnant during the study period.
- Diagnosis of angle closure glaucoma or secondary glaucoma.
- History of glaucoma surgery.
- Ophthalmologic surgery within the past 6 months.
- Difficulty with applanation tonometry measurement.
- Corneal dystrophy.
- Infectious/non-infectious conjunctivitis, keratitis, or uveitis in either eye.
- Severe blepharitis or dry eye.
- History of metal allergy.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
February 26 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2016
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02246777
Start Date
February 26 2014
End Date
October 24 2016
Last Update
July 20 2018
Active Locations (1)
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1
Contact Alcon Japan, Ltd for Trial Locations
Tokyo, Japan, 107-0052