Normal Tension GlaucomaPhase 4NCT01446497
Efficacy and Safety Study of Combigan and 0.5% Timoptic in Normal Tension Glaucoma
A Phase 4 study testing Brimonidine/Timolol mixed combination and Timolol in people with Normal Tension Glaucoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Purpose To evaluate efficacy and safety of combigan(Brimonidine/Timolol) and 0.5% Timoptic (Timolol) ophthalmic solutions in normal tension glaucoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Normal Tension Glaucoma
- What is being tested?
- Brimonidine/Timolol mixed combination and Timolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2010to Aug 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
- over 18 years old
- baseline IOP under 22 mmHg,both anterior chamber angle > Grade 3~4 by Shaffer grading system
Who cannot join
- IOP over 22 mmHg by Goldmann applanation tonometer
- other types of glaucoma except open angle
- other IOP lowering treatment
- chronic or recurrent Hx. of ocular inflammation
- using contact lens
- any other ocular disease that could affect visual field examination (diabetic retinopathy, macular disease, uveitis, scleritis, optic neuritis, anterior ischemic optic neuropathy)
Show all 16Show fewer
- intraocular or glaucoma surgery within 6 months
- Hx. of allergic reaction to timolol or brimonidine
- bronchial asthma
- moderate to severe chronic obstructive pulmonary disease
- heart failure
- 2~3 degree A-V block,
- MAO inhibitor use
- anti depressant use
- untreated pheochromocytoma
- pregnant
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Ki Ho Park, M.D., Ph.D., +82-2-2072-2438 ext. 3172, kihopark@snu.ac.kr
Jae Hoon Jeong, M.D., +82-2-2072-2438 ext. 3110, j2h23@hanmali.net
About this study
Official title: Randomized, Multicenter, Open-label, Parallel Group Study to Evaluate Efficacy and Safety of Combigan(Brimonidine/Timolol) and 0.5% Timoptic(Timolol) Ophthalmic Solutions in Normal Tension Glaucoma Patients
Purpose To evaluate efficacy and safety of combigan(Brimonidine/Timolol) and 0.5% Timoptic (Timolol) ophthalmic solutions in normal tension glaucoma patients.
Read the detailed description
- Normal tension glaucoma (NTG) is the major type of glaucoma in Korea. (over 90% of glaucoma type)
- Brimonidine (selective alpha 2 adrenergic agonist): neuroprotection effect by suppression of aqueous humor production and increasement of uveoscleral outflow
- Timolol (non selective beta blocker): suppression effect of aqueous humor production
- Combigan (fixed combination of brimonidine \& timolol): more lowering effect of intraocular pressure and enhancing the compliance of glaucoma patients
- Conditions
- Normal Tension Glaucoma
- Being tested
- Brimonidine/Timolol mixed combination, Timolol
- Keywords
- Normal tension glaucoma, Antiglaucoma ophthalmic solution, Brimonidine, Timolol, Combination drugs
- Medical subject headings
- Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine/Timolol mixed combinationDrug
Also called Combigan
Twice per day, 1 drop at each time
TimololDrug
Also called Timoptic XE
Twice per day, 1 drop at each time
| Study group | Role | What they receive |
|---|---|---|
| Timolol | Active comparator | non selective beta blocker, aqueous humor suppressant ophthalmic solution Receives: Drug: Brimonidine/Timolol mixed combination |
| Combigan (Timolol/Brimonidine) combination drug | Active comparator | Brimonidine: alpha-2 agonist Receives: Drug: Timolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in intraocular pressure at 12 weeks
Intraocular pressure (IOP) check by Goldmann applanation tonometry with topical anesthetic eyedrop
Measured: 12 weeks after the initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startOct 2010
- Primary completionAug 2011
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Tension GlaucomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ki Ho Park, M.D, Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446497
- Sponsor's protocol ID
- H-1008-059-327
- Other IDs
- KHP01
- Status last verified
- Oct 2011
- First submitted
- 25 Sep 2011
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicenter, Open-label, Parallel Group Study to Evaluate Efficacy and Safety of Combigan(Brimonidine/Timolol) and 0.5% Timoptic(Timolol) Ophthalmic Solutions in Normal Tension Glaucoma Patients
- ClinicalTrials.gov ID
- NCT01446497
- Acronym / sponsor ID
- H-1008-059-327
- Conditions
- Normal Tension Glaucoma
- Keywords
- Normal tension glaucoma, Antiglaucoma ophthalmic solution, Brimonidine, Timolol, Combination drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2012 (estimated)
- First posted
- 5 Oct 2011 (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.
Purpose To evaluate efficacy and safety of combigan(Brimonidine/Timolol) and 0.5% Timoptic (Timolol) ophthalmic solutions in normal tension glaucoma patients.
Detailed description
- Normal tension glaucoma (NTG) is the major type of glaucoma in Korea. (over 90% of glaucoma type)
- Brimonidine (selective alpha 2 adrenergic agonist): neuroprotection effect by suppression of aqueous humor production and increasement of uveoscleral outflow
- Timolol (non selective beta blocker): suppression effect of aqueous humor production
- Combigan (fixed combination of brimonidine \& timolol): more lowering effect of intraocular pressure and enhancing the compliance of glaucoma patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Timolol | Active comparator | Drug: Brimonidine/Timolol mixed combinationnon selective beta blocker, aqueous humor suppressant ophthalmic solution |
| Combigan (Timolol/Brimonidine) combination drug | Active comparator | Drug: TimololBrimonidine: alpha-2 agonist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 18 years old
- baseline IOP under 22 mmHg,both anterior chamber angle > Grade 3~4 by Shaffer grading system
Key exclusion criteria (16 listed)
- IOP over 22 mmHg by Goldmann applanation tonometer
- other types of glaucoma except open angle
- other IOP lowering treatment
- chronic or recurrent Hx. of ocular inflammation
- using contact lens
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 |
|---|---|---|
| Brimonidine/Timolol mixed combinationAlso: CombiganTwice per day, 1 drop at each time | Drug | Timolol |
| TimololAlso: Timoptic XETwice per day, 1 drop at each time | Drug | Combigan (Timolol/Brimonidine) combination drug |
Primary outcome
Change from baseline in intraocular pressure at 12 weeks
Time frame: 12 weeks after the initial treatment
Intraocular pressure (IOP) check by Goldmann applanation tonometry with topical anesthetic eyedrop
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
Related trials for Normal Tension Glaucoma
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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.
Ki Ho Park, M.D, Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brimonidine/Timolol mixed combination and Timolol in people with Normal Tension Glaucoma, run by Seoul National University Hospital at 1 site 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 2 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ki Ho Park, M.D., Ph.D. (+82-2-2072-2438 ext. 3172, kihopark@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in intraocular pressure at 12 weeks (time frame: 12 weeks after the initial 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 5 Oct 2011.