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Completed

NCT Number: NCT02246777

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Alcon Japan, Ltd for Trial Locations

Tokyo, 107-0052, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ex-PRESS® Glaucoma Filtration Device, Model P50PL

Device

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 23, 2014
Registry last updated
Jul 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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