Glaucoma, Angle-ClosureNCT00567788
Comparison of Bimatoprost and Latanoprost in Patients With Chronic Angle-Closure Glaucoma: A Randomized Cross-Over Study
A study testing Latanoprost-Bimatoprost and Bimatoporost-Latanoprost in people with Glaucoma, Angle-Closure, run by Singapore National Eye Centre at 1 site in Singapore.
Trial summary
This is a randomized observer-masked cross-over study to compare the intraocular pressure (IOP) reducing effect of latanoprost with bimatoprost in subjects with chronic angle closure glaucoma (CACG) with raised IOP. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Glaucoma, Angle-Closure
- What is being tested?
- Latanoprost-Bimatoprost and Bimatoporost-Latanoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2006to Jul 2008
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral or bilateral CACG
- Age more than or equal to 40 years old
- Informed consent obtained at pre-study visit for all patients
Who cannot join
- Secondary glaucoma such as uveitic or neovascular glaucoma
- One eye eligible and fellow eye on unsuitable glaucoma treatment for this trial
- IOP > 36 mmHg at Pre-study visit
- Advanced glaucoma at risk of progression. This is defined as vertical cup-disc ratio > 0.9 and/or central visual field loss with a sensitivity of < 10 dB in any of the 4 visual field test points closest to fixation
- Ocular infection or inflammation (except when related to peripheral iridotomy) within 3 months of the prestudy visit
- On more than two anti-glaucoma medications
Show all 18Show fewer
- Previous intraocular surgery apart from laser peripheral iridotomy
- Previous trauma to the eye, with angle damage
- Ocular treatment with a steroid or non-steroidal anti-inflammatory medication within 1 month of the prestudy visit.
- Use of contact lens.
- Cornea infection or other cornea abnormalities.
- Ocular diseases such as dry eye or retinal pathology.
- Oral medications, such as diuretics, known to affect IOP.
- Cerebrovascular, hepatic, renal, metabolic disease.
- Known allergy to benzalkonium, or any other components of latanoprost/bimatoprost.
- History of non-compliance.
- Women who are pregnant, lactating, or of childbearing potential and not using adequate contraception.
- Participated in another therapeutic medication study within the last 1 month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Bimatoprost and Lataprost in Patients With Chronic Angle-Closure Glaucoma: A Randomized Cross-Over Study
This is a randomized observer-masked cross-over study to compare the intraocular pressure (IOP) reducing effect of latanoprost with bimatoprost in subjects with chronic angle closure glaucoma (CACG) with raised IOP. Study subjects will be randomized to receive either latanoprost once daily or bimatoprost once daily for 6 weeks, after which they will be crossed over to the other medication for another 6 weeks. The IOP-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. The study will be carried out in at least 2 Singapore hospitals.
Read the detailed description
Study eyes are defined as the eye(s) that fulfil all inclusion criteria but none of the exclusion criteria. The IOP will be measured by Goldmann applanation tonometry. The IOP at every visit will be taken by one examiner (masked) using the same slit lamp and tonometer. Three consecutive readings will be taken at each time and the mean of the three values used in the statistical analysis. The examiner will not be aware of the treatment the patient is on. The scale of the tonometer will be concealed to the examiner, and the IOP value read off by an assistant after the examiner determines the end point of tonometry.
At the Baseline visit and last visit of each Treatment period (Day 0, 42 and 84), IOP will be measured at 9 am and 5 pm. On Day 14 and 56, IOP will be measured only at 9 AM.
Thus, when the IOP is measured in the clinic at 9 AM, approximately 13 hours would have elapsed from the evening dose. This will coincide with the approximate peak effect of bimatoprost and latanoprost. The IOP reading at 5 PM will be the approximate trough for latanoprost and bimatoprost.
The IOP at the end of each Treatment period at 6 weeks (Day 42 and 84) will be utilized as the primary endpoint and a comparison of mean IOPs of the two treatment groups compared with the baseline (Day 0). For those who do not, for any reason, complete the 6-week assessment, their last IOP measure will be carried forward to provide the endpoint. However, the number of such cases within each treatment group will also be reported.
Prior to the trial, all patients will undergo clinical examinations and eye tests to determine eligibility.
After being enrolled into the trial, patients will be randomized to receive either latanoprost or bimatoprost. They will be subjected to a list of tests (details of schedule and procedures in Appendix A) on the baseline day (Day 0) and instructed that the first eye application will start at 8pm on the same day. For 6 weeks, patients assigned to the latanoprost treatment group will administer latanoprost 0.005% in the evening. Patients assigned to the bimatoprost group will administer 0.03% bimatoprost once daily (in the evening). Study visits will be on Day 14 (Visit 2) and Day 42 (Visit 3).
After 6 weeks, patients will be crossed over to the other medication. Patients will undergo exactly the same regimen of examination and clinic visits as in Treatment period I. Study visits will be on Day 56 (Visit 4) and Day 84 (Visit 5).
- Conditions
- Glaucoma, Angle-Closure
- Being tested
- Latanoprost-Bimatoprost, Bimatoporost-Latanoprost
- Keywords
- Glaucoma, angle-closure
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latanoprost-BimatoprostDrug
Also called Xalatan, Lumigan
latanoprost 0.005% once daily followed by bimatoprost 0.03%
Bimatoporost-LatanoprostDrug
Also called Xalatan, Lumigan
bimatoprost 0.03% once daily followed by latanoprost 0.005%
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Study subjects will be randomized to receive either latanoprost once daily or bimatoprost once daily for 6 weeks, after which they will be crossed over to the other medication for another 6 weeks. The IOP-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. Receives: Drug: Latanoprost-Bimatoprost |
| 2 | Active comparator | Study subjects will be randomized to receive either latanoprost once daily or bimatoprost once daily for 6 weeks, after which they will be crossed over to the other medication for another 6 weeks. The IOP-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. Receives: Drug: Bimatoporost-Latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is defined as IOP reduction from baseline measurement (week 0) to the measurement at week 6 at each treatment period.
Measured: 6 weeks
Secondary outcomes (1)
Incidence of side effects of each medication.
Measured: 6 weeks after each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startJul 2006
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Angle-ClosureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Collaborators
- Allergan
- Investigators
- Tin Aung, Principal investigator, SNEC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567788
- Sponsor's protocol ID
- R353/11/2004
- Other IDs
- SQGL08
- Status last verified
- Nov 2007
- First submitted
- 4 Dec 2007
- Last updated
- 5 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bimatoprost and Lataprost in Patients With Chronic Angle-Closure Glaucoma: A Randomized Cross-Over Study
- ClinicalTrials.gov ID
- NCT00567788
- Acronym / sponsor ID
- R353/11/2004
- Conditions
- Glaucoma, Angle-Closure
- Keywords
- Glaucoma, angle-closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Singapore National Eye CentreOther government
- Collaborators
- Allergan
- Study start
- Jul 2006
- Study completion
- Jul 2008 (estimated)
- First posted
- 5 Dec 2007 (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.
This is a randomized observer-masked cross-over study to compare the intraocular pressure (IOP) reducing effect of latanoprost with bimatoprost in subjects with chronic angle closure glaucoma (CACG) with raised IOP. Study subjects will be randomized to receive either latanoprost once daily or bimatoprost once daily for 6 weeks, after which they will be crossed over to the other medication for another 6 weeks. The IOP-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. The study will be carried out in at least 2 Singapore hospitals.
Detailed description
Study eyes are defined as the eye(s) that fulfil all inclusion criteria but none of the exclusion criteria. The IOP will be measured by Goldmann applanation tonometry. The IOP at every visit will be taken by one examiner (masked) using the same slit lamp and tonometer. Three consecutive readings will be taken at each time and the mean of the three values used in the statistical analysis. The examiner will not be aware of the treatment the patient is on. The scale of the tonometer will be concealed to the examiner, and the IOP value read off by an assistant after the examiner determines the end point of tonometry.
At the Baseline visit and last visit of each Treatment period (Day 0, 42 and 84), IOP will be measured at 9 am and 5 pm. On Day 14 and 56, IOP will be measured only at 9 AM.
Thus, when the IOP is measured in the clinic at 9 AM, approximately 13 hours would have elapsed from the evening dose. This will coincide with the approximate peak effect of bimatoprost and latanoprost. The IOP reading at 5 PM will be the approximate trough for latanoprost and bimatoprost.
The IOP at the end of each Treatment period at 6 weeks (Day 42 and 84) will be utilized as the primary endpoint and a comparison of mean IOPs of the two treatment groups compared with the baseline (Day 0). For those who do not, for any reason, complete the 6-week assessment, their last IOP measure will be carried forward to provide the endpoint. However, the number of such cases within each treatment group will also be reported.
Prior to the trial, all patients will undergo clinical examinations and eye tests to determine eligibility.
After being enrolled into the trial, patients will be randomized to receive either latanoprost or bimatoprost. They will be subjected to a list of tests (details of schedule and procedures in Appendix A) on the baseline day (Day 0) and instructed that the first eye application will start at 8pm on the same day. For 6 weeks, patients assigned to the latanoprost treatment group will administer latanoprost 0.005% in the evening. Patients assigned to the bimatoprost group will administer 0.03% bimatoprost once daily (in the evening). Study visits will be on Day 14 (Visit 2) and Day 42 (Visit 3).
After 6 weeks, patients will be crossed over to the other medication. Patients will undergo exactly the same regimen of examination and clinic visits as in Treatment period I. Study visits will be on Day 56 (Visit 4) and Day 84 (Visit 5).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Latanoprost-BimatoprostStudy subjects will be randomized to receive either latanoprost once daily or bimatoprost once daily for 6 weeks, after which they will be crossed over to the other medication for another 6 weeks. The IOP-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. |
| 2 | Active comparator | Drug: Bimatoporost-LatanoprostStudy subjects will be randomized to receive either latanoprost once daily or bimatoprost once daily for 6 weeks, after which they will be crossed over to the other medication for another 6 weeks. The IOP-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral or bilateral CACG
- Age more than or equal to 40 years old
- Informed consent obtained at pre-study visit for all patients
Key exclusion criteria (18 listed)
- Secondary glaucoma such as uveitic or neovascular glaucoma
- One eye eligible and fellow eye on unsuitable glaucoma treatment for this trial
- IOP > 36 mmHg at Pre-study visit
- Advanced glaucoma at risk of progression. This is defined as vertical cup-disc ratio > 0.9 and/or central visual field loss with a sensitivity of < 10 dB in any of the 4 visual field test points closest to fixation
- Ocular infection or inflammation (except when related to peripheral iridotomy) within 3 months of the prestudy 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 |
|---|---|---|
| Latanoprost-BimatoprostAlso: Xalatan, Lumiganlatanoprost 0.005% once daily followed by bimatoprost 0.03% | Drug | 1 |
| Bimatoporost-LatanoprostAlso: Xalatan, Lumiganbimatoprost 0.03% once daily followed by latanoprost 0.005% | Drug | 2 |
Primary outcome
The primary endpoint is defined as IOP reduction from baseline measurement (week 0) to the measurement at week 6 at each treatment period.
Time frame: 6 weeks
1 secondary outcome
Incidence of side effects of each medication.
Time frame: 6 weeks after each treatment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2007.
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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.
Tin Aung principal investigator
SNEC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Latanoprost-Bimatoprost and Bimatoporost-Latanoprost in people with Glaucoma, Angle-Closure, run by Singapore National Eye Centre at 1 site in Singapore.
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 3 inclusion and 18 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 Dec 2007. 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 Singapore. 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.
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?
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?
The primary endpoint is defined as IOP reduction from baseline measurement (week 0) to the measurement at week 6 at each treatment period. (time frame: 6 weeks). 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 Dec 2007.