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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

Tracking Information
First Submitted Date  ICMJE August 11, 2016
First Posted Date  ICMJE August 22, 2016
Last Update Posted Date December 18, 2017
Study Start Date  ICMJE March 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2016)
Mean intraocular pressure reduction of 20% or more versus baseline with reduction of 1 medication [ Time Frame: 12 months postoperative ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02873806 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2016)
Mean intraocular pressure of 18 mmHg or less versus baseline with reduction of 1 medication [ Time Frame: 12 months postoperative ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Open-angle Glaucoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Interventions:
  • Procedure: Implantation of two iStent inject micro-bypass stents
  • Drug: Topical travoprost
  • Device: Two iStent inject micro-bypass stents
  • Drug: Tobramycin
  • Drug: Dexamethasone
Publications * Berdahl J, Voskanyan L, Myers JS, Hornbeak DM, Giamporcaro JE, Katz LJ, Samuelson TW. Implantation of two second-generation trabecular micro-bypass stents and topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 18-month follow-up. Clin Exp Ophthalmol. 2017 Nov;45(8):797-802. doi: 10.1111/ceo.12958. Epub 2017 Jun 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 19, 2016)
53
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2019
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Armenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02873806
Other Study ID Numbers  ICMJE GCF-039
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Glaukos Corporation
Study Sponsor  ICMJE Glaukos Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lilit Voskanyan, MD, PhD S.V. Malayan Eye Center
PRS Account Glaukos Corporation
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP