Open Angle GlaucomaPhase 4NCT01055366
ELAZOP Switching Study in Korea
A Phase 4 study testing Elazop (Azarga) in people with Open Angle Glaucoma, run by Alcon Research at 10 sites in South Korea.
Trial summary
The purpose of this study is to assess the safety and efficacy of switching to ELAZOP from prior pharmacotherapy in patients with open-angled glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Elazop (Azarga)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Mar 2010to Dec 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
- Must be on a stable regimen of Intraocular Pressure (IOP) lowering medication (i.e., either a single therapeutic agent or two separate ocular hypotensive agents) for at least one month prior to the Screening Visit.
- Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
- Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in the study that is deemed clinically significant in the opinion of the Principal Investigator.
- Intraocular conventional surgery or laser surgery in either eye less than three months prior to the Screening visit.
- History of ocular herpes simplex.
- Pregnant or lactating.
- Participation in any other investigational study within 30 days of Screening visit.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Youngnam Univ. Hospital
Daegu, Daegu, 705-707
Seoul National University Hospital
Seoul, 110-744
Yonsei University Severance Hospital
Seoul, 120-752
Samsung Medical Center
Seoul, 135-710
Yonsei University Kangnam Severance Hospital
Seoul, 135-720
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, 137-040
Asan Medical Center
Seoul, 138-706
Kim's Eye Hospital
Seoul, 150-034
St. Mary's Hospital, The Catholic University of Korea
Seoul, 150-703
Seoul National University Bundang Hospital
Sungnam, Gyounggi, 463-707
About this study
The purpose of this study is to assess the safety and efficacy of switching to ELAZOP from prior pharmacotherapy in patients with open-angled glaucoma.
- Conditions
- Open Angle Glaucoma
- Being tested
- Elazop (Azarga)
- Keywords
- Open angle glaucoma, OAG, Elazop, Azarga, Brinzolamide/Timolol combination
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elazop (Azarga)Drug
Administer one drop of ELAZOP in treated eye(s) twice a day for up to 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Elazop (Azarga) | Experimental | Elazop Treatment arm Receives: Drug: Elazop (Azarga) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure (IOP) change from baseline at final visit.
Measured: 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055366
- Sponsor's protocol ID
- RM-09-06
- Status last verified
- May 2012
- First submitted
- 22 Jan 2010
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELAZOP Switching Study in Korea
- ClinicalTrials.gov ID
- NCT01055366
- Acronym / sponsor ID
- RM-09-06
- Conditions
- Open Angle Glaucoma
- Keywords
- Open angle glaucoma, OAG, Elazop, Azarga, Brinzolamide/Timolol combination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Jan 2010 (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.
The purpose of this study is to assess the safety and efficacy of switching to ELAZOP from prior pharmacotherapy in patients with open-angled glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elazop (Azarga) | Experimental | Drug: Elazop (Azarga)Elazop Treatment arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older.
- Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
- Must be on a stable regimen of Intraocular Pressure (IOP) lowering medication (i.e., either a single therapeutic agent or two separate ocular hypotensive agents) for at least one month prior to the Screening Visit.
- Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
- Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
Key exclusion criteria (6 listed)
- Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in the study that is deemed clinically significant in the opinion of the Principal Investigator.
- Intraocular conventional surgery or laser surgery in either eye less than three months prior to the Screening visit.
- History of ocular herpes simplex.
- Pregnant or lactating.
- Participation in any other investigational study within 30 days of Screening visit.
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 |
|---|---|---|
| Elazop (Azarga)Administer one drop of ELAZOP in treated eye(s) twice a day for up to 12 weeks | Drug | Elazop (Azarga) |
Primary outcome
Mean Intraocular Pressure (IOP) change from baseline at final visit.
Time frame: 12 weeks after treatment
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 17 Dec 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elazop (Azarga) in people with Open Angle Glaucoma, run by Alcon Research at 10 sites in South Korea.
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 6 inclusion and 6 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 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. 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) change from baseline at final visit. (time frame: 12 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2012.