GlaucomaNCT00347126
Results of Mass Switch From Latanoprost to Travoprost
An observational study of Glaucoma, run by Singapore National Eye Centre at 1 site in Singapore.
Trial summary
Prostaglandin analogs are a leading class of glaucoma drugs with a proven safety and efficacy for controlling IOP. They include latanoprost, bimatoprost, travoprost and unoprostone. Recently, the Singapore National Eye Center (SNEC) awarded a tender for prostaglandin analogues to Alcon, the manufacturer of travoprost. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma
- How many people
- 372 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2006to Apr 2008
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients on treatment with latanoprost who are switched to travoprost therapy
Who may be able to join
- Patients on treatment with latanoprost for at least 12 weeks; patients who are on additional beta-blockers topically will also be eligible.
- Written informed consent. -
Who cannot join
- Patients on 3 or more topical medications.
- Recorded history of intolerance to travoprost.
- Recorded history of inefficacy of travoprost in controlling IOP.
- Patients on any additional topical medication other than beta-blockers.
- History of non-compliance.
- Involvement in any other concomitant study. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of a Systematic Switch From Latanoprost to Travoprost in Patients With Glaucoma
Prostaglandin analogs are a leading class of glaucoma drugs with a proven safety and efficacy for controlling IOP. They include latanoprost, bimatoprost, travoprost and unoprostone. Recently, the Singapore National Eye Center (SNEC) awarded a tender for prostaglandin analogues to Alcon, the manufacturer of travoprost. Since then, all subsidized patients previously treated with latanoprost were systematically switched to travoprost and this process will continue for the rest of this year. In this study, we propose to prospectively study the efficacy and safety of switching from latanoprost to travoprost in a large series of glaucoma patients at SNEC. A total of 372 consecutive patients being switched from latanoprost to travoprost will be followed up for 12 weeks following the switch. In addition to intraocular pressure, the safety and tolerability (with particular emphasis on hyperemia) of travoprost will be examined.
Read the detailed description
Aims:
- To assess the feasibility of switching a large group of patients on treatment with latanoprost to travoprost.
- To assess the efficacy and safety of travoprost compared to latanoprost after the switch.
Intraocular pressure (IOP) is currently the only proven modifiable risk factor in the management of glaucoma.1 Either medical or surgical management can achieve the control of IOP. Prostaglandin analogs are the newer class of drugs among the various topical ocular hypotensive medications, with a proven safety and efficacy for controlling IOP.2 Their potency and once a day dosing and lower incidence of systemic side effects have made them popular for use as monotherapeutic and first-line agents. They include latanoprost, bimatoprost, travoprost and unoprostone. All of them have a similar molecular structure and they work by increasing the aqueous drainage via trabecular meshwork and the uveoscleral pathway.3 It has been shown that the efficacy of latanoprost, bimatoprost and travoprost in reducing IOP in ocular hypertension and primary open angle glaucoma is comparable.4 Conjunctival hyperemia is one of the most common ocular side effects. There has been a reported higher incidence of hyperemia with bimatoprost and travoprost as compared to latanoprost.4 However, this hyperemia is usually benign and usually abates as the drug is used long term. The incidence of discontinuation of therapy due to hyperemia is very low and not different among the various prostaglandins.5 Among the prostaglandin analogues, latanoprost has been the market leader in Singapore for the past few years. However, the Singapore National Eye Center (SNEC) pharmacy recently accepted tenders from various drug companies for prostaglandin analogs. Alcon, the manufacturer of travoprost was awarded the tender. Since then, all subsidized patients previously treated with latanoprost were systematically switched to travoprost and this process will continue for the rest of this year. The switch is a systematic switch and is not based on intolerance or poor response to latanoprost.
To date, there has been a single report regarding the feasibility and efficacy of a mass switch from latanoprost to bimatoprost.5 The study reported a high switch rate and good IOP control with minimal switch back. However, similar data on switching from latanoprost to travoprost is lacking. In this study, we propose to prospectively study the efficacy and safety of switching from latanoprost to travoprost in a large series of glaucoma patients at SNEC. A total of 372 consecutive patients being switched from latanoprost to travoprost will be followed up for 12 weeks following the switch. In addition to IOP, safety and tolerability (with particular emphasis on hyperemia) of travoprost will be examined.
References:
- Leske MC, Heijl A, Hussein M et al. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch Ophthalmol. 2003 Jan;121(1):48-56.
- Alexander CL, Miller SJ, Abel SR. Prostaglandin analog treatment of glaucoma and ocular hypertension. Ann Pharmacother. 2002 Mar;36(3):504-11.3.
- Eisenberg DL, Toris CB, Camras CB. Bimatoprost and travoprost: a review of recent studies of two new glaucoma drugs. Surv Ophthalmol. 2002 Aug;47 Suppl 1:S105-15.
- Parrish RK, Palmberg P, Sheu WP; XLT Study Group. A comparison of latanoprost, bimatoprost, and travoprost in patients with elevated intraocular pressure: a 12-week, randomized, masked-evaluator multicenter study. Am J Ophthalmol. 2003 May;135(5):688-703.
- Law SK, Song BJ, Fang E, Caprioli J. Feasibility and efficacy of a mass switch from latanoprost to bimatoprost in glaucoma patients in a prepaid Health Maintenance Organization. Ophthalmology. 2005 Dec;112(12):2123-30.
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Latanoprost, Travoprost, Intraocular pressure, Hyperemia
- Medical subject headings
- Glaucoma, Hyperemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startApr 2006
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Investigators
- Tin Aung, FRCS, PhD, Principal investigator, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347126
- Sponsor's protocol ID
- R463/12/2006
- Status last verified
- May 2010
- First submitted
- 30 Jun 2006
- Last updated
- 12 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Systematic Switch From Latanoprost to Travoprost in Patients With Glaucoma
- ClinicalTrials.gov ID
- NCT00347126
- Acronym / sponsor ID
- R463/12/2006
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Latanoprost, Travoprost, Intraocular pressure, Hyperemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- Apr 2006
- Study completion
- Apr 2008 (actual)
- First posted
- 4 Jul 2006 (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.
Prostaglandin analogs are a leading class of glaucoma drugs with a proven safety and efficacy for controlling IOP. They include latanoprost, bimatoprost, travoprost and unoprostone. Recently, the Singapore National Eye Center (SNEC) awarded a tender for prostaglandin analogues to Alcon, the manufacturer of travoprost. Since then, all subsidized patients previously treated with latanoprost were systematically switched to travoprost and this process will continue for the rest of this year. In this study, we propose to prospectively study the efficacy and safety of switching from latanoprost to travoprost in a large series of glaucoma patients at SNEC. A total of 372 consecutive patients being switched from latanoprost to travoprost will be followed up for 12 weeks following the switch. In addition to intraocular pressure, the safety and tolerability (with particular emphasis on hyperemia) of travoprost will be examined.
Detailed description
Aims:
- To assess the feasibility of switching a large group of patients on treatment with latanoprost to travoprost.
- To assess the efficacy and safety of travoprost compared to latanoprost after the switch.
Intraocular pressure (IOP) is currently the only proven modifiable risk factor in the management of glaucoma.1 Either medical or surgical management can achieve the control of IOP. Prostaglandin analogs are the newer class of drugs among the various topical ocular hypotensive medications, with a proven safety and efficacy for controlling IOP.2 Their potency and once a day dosing and lower incidence of systemic side effects have made them popular for use as monotherapeutic and first-line agents. They include latanoprost, bimatoprost, travoprost and unoprostone. All of them have a similar molecular structure and they work by increasing the aqueous drainage via trabecular meshwork and the uveoscleral pathway.3 It has been shown that the efficacy of latanoprost, bimatoprost and travoprost in reducing IOP in ocular hypertension and primary open angle glaucoma is comparable.4 Conjunctival hyperemia is one of the most common ocular side effects. There has been a reported higher incidence of hyperemia with bimatoprost and travoprost as compared to latanoprost.4 However, this hyperemia is usually benign and usually abates as the drug is used long term. The incidence of discontinuation of therapy due to hyperemia is very low and not different among the various prostaglandins.5 Among the prostaglandin analogues, latanoprost has been the market leader in Singapore for the past few years. However, the Singapore National Eye Center (SNEC) pharmacy recently accepted tenders from various drug companies for prostaglandin analogs. Alcon, the manufacturer of travoprost was awarded the tender. Since then, all subsidized patients previously treated with latanoprost were systematically switched to travoprost and this process will continue for the rest of this year. The switch is a systematic switch and is not based on intolerance or poor response to latanoprost.
To date, there has been a single report regarding the feasibility and efficacy of a mass switch from latanoprost to bimatoprost.5 The study reported a high switch rate and good IOP control with minimal switch back. However, similar data on switching from latanoprost to travoprost is lacking. In this study, we propose to prospectively study the efficacy and safety of switching from latanoprost to travoprost in a large series of glaucoma patients at SNEC. A total of 372 consecutive patients being switched from latanoprost to travoprost will be followed up for 12 weeks following the switch. In addition to IOP, safety and tolerability (with particular emphasis on hyperemia) of travoprost will be examined.
References:
- Leske MC, Heijl A, Hussein M et al. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch Ophthalmol. 2003 Jan;121(1):48-56.
- Alexander CL, Miller SJ, Abel SR. Prostaglandin analog treatment of glaucoma and ocular hypertension. Ann Pharmacother. 2002 Mar;36(3):504-11.3.
- Eisenberg DL, Toris CB, Camras CB. Bimatoprost and travoprost: a review of recent studies of two new glaucoma drugs. Surv Ophthalmol. 2002 Aug;47 Suppl 1:S105-15.
- Parrish RK, Palmberg P, Sheu WP; XLT Study Group. A comparison of latanoprost, bimatoprost, and travoprost in patients with elevated intraocular pressure: a 12-week, randomized, masked-evaluator multicenter study. Am J Ophthalmol. 2003 May;135(5):688-703.
- Law SK, Song BJ, Fang E, Caprioli J. Feasibility and efficacy of a mass switch from latanoprost to bimatoprost in glaucoma patients in a prepaid Health Maintenance Organization. Ophthalmology. 2005 Dec;112(12):2123-30.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients on treatment with latanoprost who are switched to travoprost therapy
Key inclusion criteria (2 listed)
- Patients on treatment with latanoprost for at least 12 weeks; patients who are on additional beta-blockers topically will also be eligible.
- Written informed consent. -
Key exclusion criteria (6 listed)
- Patients on 3 or more topical medications.
- Recorded history of intolerance to travoprost.
- Recorded history of inefficacy of travoprost in controlling IOP.
- Patients on any additional topical medication other than beta-blockers.
- History of non-compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 12 May 2010.
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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, FRCS, PhD principal investigator
Singapore National Eye Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, 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 2 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 12 May 2010. 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?
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.
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 12 May 2010.