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Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents

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ClinicalTrials.gov Identifier: NCT02873806
Recruitment Status : Active, not recruiting
First Posted : August 22, 2016
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Brief Summary:
The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma Procedure: Implantation of two iStent inject micro-bypass stents Drug: Topical travoprost Device: Two iStent inject micro-bypass stents Drug: Tobramycin Drug: Dexamethasone Phase 4

Detailed Description:

The study design is as follows:

  • Prospective, single-arm study.
  • Subjects with open-angle glaucoma and medicated IOP > 18 mmHg and ≤ 30 mmHg.
  • Subjects on two topical ocular hypotensive medications (one a prostaglandin).
  • Implantation of two iStent inject devices (if IOP is < 6 mmHg, at any point during the postoperative follow-up, medication will not be prescribed or will be discontinued).
  • IOP will be measured by two (2) observers to minimize bias; observer 1 will look through the slit lamp and turn the dial with readings being masked, and observer 2 will document the IOP.
  • Follow-up through 60 months postoperative (or up to 61 months if subject needs to undergo terminal washout).
  • Descriptive statistics will be tabulated.
  • Medical therapy considered necessary for the subject's welfare can be implemented at any time during the study at the investigator's discretion.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medications (One a Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject) and a Postoperative Topical Prostaglandin
Study Start Date : March 2013
Actual Primary Completion Date : April 2015
Estimated Study Completion Date : April 2019


Arm Intervention/treatment
2 micro-bypass stents & travoprost

Two iStent inject micro-bypass stents and topical travoprost

Intervention:

  • Implantation of two iStent inject micro-bypass stents
  • Tobramycin
  • Dexamethasone
Procedure: Implantation of two iStent inject micro-bypass stents
- Implantation of two trabecular micro-bypass stents (iStent inject) in a standalone procedure (i.e., without cataract surgery).
Other Name: iStent inject

Drug: Topical travoprost
- Topical travoprost (0.004%, 1 drop each evening in study eye) started on postoperative Day 1.
Other Name: travoprost

Device: Two iStent inject micro-bypass stents
- Two trabecular micro-bypass stents (iStent inject) implanted in a standalone procedure.
Other Name: iStent inject

Drug: Tobramycin

Topical antibiotic (tobramycin):

1 drop four (4) times per day in the study eye for one week (in cases of allergy or contraindication, Polytrim (polymyxin B sulfate + trimethoprim sulfate ophthalmic solution, USP, or equivalent) may be used as an alternative medication) .


Drug: Dexamethasone

Topical anti-inflammatory medication (dexamethasone ophthalmic suspension 0.1%):

  • Week 1: 1 drop four (4) times per day in the study eye
  • Week 2: 1 drop three (3) times per day in the study eye
  • Week 3: 1 drop two (2) times per day in the study eye
  • Week 4: 1 drop one (1) time per day in the study eye




Primary Outcome Measures :
  1. Mean intraocular pressure reduction of 20% or more versus baseline with reduction of 1 medication [ Time Frame: 12 months postoperative ]

Secondary Outcome Measures :
  1. Mean intraocular pressure of 18 mmHg or less versus baseline with reduction of 1 medication [ Time Frame: 12 months postoperative ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Screening Exam Inclusion Criteria:

  • Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)
  • Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)
  • C/D ratio ≤ 0.9
  • Visual field defects, or nerve abnormality characteristic of glaucoma
  • Two topical hypotensive medications at time of screening exam
  • IOP > 18 mmHg and ≤ 30 mmHg (medicated) at screening exam
  • Study eye BCVA 20/100 or better
  • Normal angle anatomy as determined by gonioscopy
  • Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of stent

Baseline Exam Inclusion Criteria:

  • Subject has completed appropriate medication washout
  • Mean IOP > 22 mmHg and ≤ 38 mmHg after anti-glaucoma medication washout period
  • A 3mmHg IOP increase over screening mean IOP

Exclusion Criteria:

Screening Exam Exclusion Criteria:

  • Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)
  • Prior stent implantations (study eye)
  • Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
  • Functionally significant visual field loss, including severe nerve fiber bundle defects
  • Prior incisional glaucoma surgery
  • Prior SLT within 90 days prior to screening
  • Prior ALT
  • Iridectomy or laser iridotomy
  • Ineligibility for ocular hypotensive medication washout period as determined by the investigator.
  • Any active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)
  • Clinically significant corneal dystrophy (e.g., bullous keratopathy, Fuch's dystrophy); any guttata
  • Corneal surgery (prior or anticipated) of any type (including LASIK, LASEK, PRK, etc.) that may interfere with IOP measurement reliability
  • Corneal opacities that would inhibit visualization of the nasal angle
  • Congenital or traumatic cataract
  • Retinal or optic nerve disorders that are not associated with the existing glaucoma condition
  • Elevated episcleral venous pressure such as associated with: active thyroid orbitopathy; cavernous sinus fistula; Sturge-Weber syndrome; orbital tumors; orbital congestive disease
  • Clinically significant sequelae from trauma
  • Chronic ocular inflammatory disease or presence of active ocular inflammation

Baseline Exam Exclusion Criteria:

  • Subject did not complete medication washout
  • Mean IOP < 22 mmHg or > 38 mmHg after anti-glaucoma medication washout
  • Subject does not have a 3mmHg IOP increase over screening mean diurnal

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): NCT02873806


Locations
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Armenia
S.V. Malayan's Ophtalmology Centre
Yerevan, Armenia, 375108
Sponsors and Collaborators
Glaukos Corporation
Investigators
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Principal Investigator: Lilit Voskanyan, MD, PhD S.V. Malayan Eye Center

Publications:
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Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT02873806     History of Changes
Other Study ID Numbers: GCF-039
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases
Glaucoma
Glaucoma, Open-Angle
Dexamethasone
Dexamethasone acetate
BB 1101
Tobramycin
Travoprost
Antihypertensive Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents