Alcon® Ex-PRESS® Glaucoma Filtration Device in Japanese Patients

Glaucoma Clinical Trial

Official title:

Assessment of Efficacy and Safety of the EX-PRESS® Glaucoma Filtration Device in Patients With Normal Tension Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246777
• Other study ID #: ALJ-P2013-1
• Secondary ID: UMIN000013243
• Status: Completed
• Phase: N/A
• Start date: February 26, 2014
• Est. completion date: October 24, 2016

Study information

• Verified date: July 2018
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 24, 2016
• Est. primary completion date: October 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Ex-PRESS® Glaucoma Filtration Device, Model P50PL

Locations

Country	Name	City	State
Japan	Contact Alcon Japan, Ltd for Trial Locations	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Intraocular Pressure (IOP)	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.	Month 3, Month 6, Month 12 Post-Operative
Primary	Change From Baseline in IOP	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.	Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
Primary	Percent Change From Baseline in IOP	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.	Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
Primary	Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.	Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative
Primary	Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol.	Month 3, Month 6, Month 12 Post-Operative
Primary	Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP	IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Secondary surgical treatment included needling, laser suture lysis, and conjunctival and scleral flap sutures. For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol. An eye may have received more than one procedure.	Month 3, Month 6, Month 12 Post-Operative

External Links

•   Results from the Novartis Clinical Trial Results Website