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

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ClinicalTrials.gov Identifier: NCT02246777
Recruitment Status : Completed
First Posted : September 23, 2014
Results First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

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.

Condition or disease Intervention/treatment Phase
Glaucoma Device: Ex-PRESS® Glaucoma Filtration Device, Model P50PL Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Efficacy and Safety of the EX-PRESS® Glaucoma Filtration Device in Patients With Normal Tension Glaucoma
Actual Study Start Date : February 26, 2014
Actual Primary Completion Date : October 24, 2016
Actual Study Completion Date : October 24, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Ex-PRESS
Ex-PRESS® Glaucoma Filtration Device, Model P50PL, implanted in the anterior chamber of the study eye during glaucoma surgery intended for the lifetime of the patient
Device: Ex-PRESS® Glaucoma Filtration Device, Model P50PL



Primary Outcome Measures :
  1. Mean Intraocular Pressure (IOP) [ Time Frame: Month 3, Month 6, Month 12 Post-Operative ]
    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.

  2. Change From Baseline in IOP [ Time Frame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative ]
    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.

  3. Percent Change From Baseline in IOP [ Time Frame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative ]
    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.

  4. Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12 [ Time Frame: Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative ]
    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.

  5. Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP [ Time Frame: Month 3, Month 6, Month 12 Post-Operative ]
    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.

  6. Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP [ Time Frame: Month 3, Month 6, Month 12 Post-Operative ]
    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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246777


Locations
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Japan
Contact Alcon Japan, Ltd for Trial Locations
Tokyo, Japan, 107-0052
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Alcon, A Novartis Division Alcon Japan, Ltd.

Additional Information:
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02246777     History of Changes
Other Study ID Numbers: ALJ-P2013-1
UMIN000013243 ( Registry Identifier: UMIN )
First Posted: September 23, 2014    Key Record Dates
Results First Posted: July 20, 2018
Last Update Posted: July 20, 2018
Last Verified: July 2018

Keywords provided by Alcon Research:
Glaucoma

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases