Eye DiseasesPhase 4SLNCT00913029
Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG)
A Phase 4 study testing iStent and latanoprost/timolol in people with Eye Diseases and Glaucoma, Open-Angle, run by Glaukos Corporation at 16 sites in 9 countries.
Trial summary
Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Diseases, Glaucoma, Open-Angle, Glaucoma
- What is being tested?
- iStent and latanoprost/timolol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 16 sitesin 9 countries
- Study dates
- May 2009to Sep 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary open-angle glaucoma
- Male or female at least 18 years of age and able to provide written informed consent
- Mean IOP (at baseline visit after washout of any medications) must be 22 mm Hg and no greater than 38 mm Hg
- Likely to be available and willing to attend follow-up visits
Who cannot join
- Angle closure glaucoma
- Secondary glaucomas
- Prior glaucoma procedures
- Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease
Trial locations and contacts
16 sites in 9 countries.
16 sites in 9 countries
Germany3 sites
Knapschaftskrankenhaus Bochum Langendreer
Bochum, 44892
Helios Cliniic
Erfurt, 99089
Universitatsklinkum Erlangen
Erlangen
Italy3 sites
Universita'degli Studi di Parma
Parma, 43100
Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica
Torino, 10128
Azienda Ospedaliera S. Maria della Misericordia
Udine, 33100
Spain3 sites
Hospital Torrevieja Salud, UTE
Alicante, 03186
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario Miguel Servet
Zaragoza
France2 sites
CHU de Lyon Hopital Edouard Herriot
Lyon, 69437
CHNO des Quinze-Vingts
Paris, 75012
About this study
Official title: A Prospective, Unmasked, Randomized Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-Angle Glaucoma
Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.
Read the detailed description
Two hundred patients will be enrolled in the study at up to 21 clinical sites; follow-up is through 1 year.
- Conditions
- Eye Diseases, Glaucoma, Open-Angle, Glaucoma
- Being tested
- iStent, latanoprost/timolol
- Keywords
- primary open angle glaucoma (POAG), OAG, glaucoma
- Medical subject headings
- Eye Diseases, Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iStentDevice
Also called stent, Trabecular micro bypass
iStent
latanoprost/timololDrug
Combination latanoprost/timolol
| Study group | Role | What they receive |
|---|---|---|
| Stent | Active comparator | One hundred patients will be randomized to implantation of two G2 stents in at least one eye. Receives: Device: iStent |
| Medication | Active comparator | One hundred patients will be randomized to receive a fixed combination ocular hypotensive medication. Receives: Drug: latanoprost/timolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean intraocular pressure (IOP)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Wells, PharmD, MBA, Study director, Glaukos Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913029
- Sponsor's protocol ID
- Second Line
- Other IDs
- Second Line Trial
- Acronym
- SL
- Status last verified
- May 2015
- First submitted
- 1 Jun 2009
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fea AM, Belda JI, Rekas M, Junemann A, Chang L, Pablo L, Voskanyan L, Katz LJ. Prospective unmasked randomized evaluation of the iStent inject ((R)) versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Clin Ophthalmol. 2014 May 7;8:875-82. doi: 10.2147/OPTH.S59932. eCollection 2014.
PubMed 24855336
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Unmasked, Randomized Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT00913029
- Acronym / sponsor ID
- SL / Second Line
- Conditions
- Eye Diseases, Glaucoma, Open-Angle, Glaucoma
- Keywords
- primary open angle glaucoma (POAG), OAG, glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.
Detailed description
Two hundred patients will be enrolled in the study at up to 21 clinical sites; follow-up is through 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent | Active comparator | Device: iStentOne hundred patients will be randomized to implantation of two G2 stents in at least one eye. |
| Medication | Active comparator | Drug: latanoprost/timololOne hundred patients will be randomized to receive a fixed combination ocular hypotensive medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of primary open-angle glaucoma
- Male or female at least 18 years of age and able to provide written informed consent
- Mean IOP (at baseline visit after washout of any medications) must be 22 mm Hg and no greater than 38 mm Hg
- Likely to be available and willing to attend follow-up visits
Key exclusion criteria (4 listed)
- Angle closure glaucoma
- Secondary glaucomas
- Prior glaucoma procedures
- Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iStentAlso: stent, Trabecular micro bypassiStent | Device | Stent |
| latanoprost/timololCombination latanoprost/timolol | Drug | Medication |
Primary outcome
Mean intraocular pressure (IOP)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
- Results publication: PubMed 24855336Fea AM, Belda JI, Rekas M, Junemann A, Chang L, Pablo L, Voskanyan L, Katz LJ. Prospective unmasked randomized evaluation of the iStent inject ((R)) versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Clin Ophthalmol. 2014 May 7;8:875-82. doi: 10.2147/OPTH.S59932. eCollection 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Wells, PharmD, MBA study director
Glaukos Corporation
16 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing iStent and latanoprost/timolol in people with Eye Diseases and Glaucoma, Open-Angle, run by Glaukos Corporation at 16 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, Italy, Spain, France, Armenia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean intraocular pressure (IOP) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00913029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.