GlaucomaPhase 4NCT00224289
Effect of Age on Latanoprost 0.005% in Patients With Glaucoma
A Phase 4 study testing Latanoprost 0.005% in people with Glaucoma, run by Yale University at 1 site in United States.
Trial summary
Latanoprost is a commonly used treatment for glaucoma. Because of its mechanism of action, it is plausible that the age of a patient using the medication may affect its efficacy and time of onset. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Latanoprost 0.005%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Apr 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis of open angle glaucoma,
- pseudoexfoliation glaucoma, pigmentary glaucoma or ocular hypertension in one or both eyes;
- IOP above their target pressure as determined by a glaucoma specialist;
- willingness to participate in the study.
Who cannot join
- hypersensitivity to any of the components of the treatment medication;
- previous use of topical prostaglandins;
- documented ocular infection or intraocular inflammation within the past year;
- previous filtering surgery or complicated cataract surgery;
- active corneal disease;
- presence of cystoid macular edema;
- laser trabeculoplasty or any other ocular laser procedure within the past three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Age on Efficacy and Response Time of Latanoprost 0.005% in Patients With Glaucoma
Latanoprost is a commonly used treatment for glaucoma. Because of its mechanism of action, it is plausible that the age of a patient using the medication may affect its efficacy and time of onset.
We are going to study the effectiveness of Latanoprost in people of different ages, to see if it changes based on the age of the patient.
Read the detailed description
Latanoprost is a topical ocular hypotensive medication with a well established safety and efficacy profile. Its effect is mediated by an increase in uveoscleral outflow, due to enzymatic degradation of the extracellular matrix within the ciliary muscle. Since the amount of extracellular matrix within the human eye increases with age, and uveoscleral outflow decreases with age, it would be expected that there should be a difference in the efficacy of latanoprost in patients of different ages. This has not been demonstrated in studies assessing the overall effect of latanoprost across adult age groups using multivariate analysis. (Camras CB et al, 1996).
However, a difference in timing of onset of drug effect may get overlooked in clinical studies and in clinical practice as well, as patients tend to be seen from two to eight weeks after initiation of treatment, by which time any differences in response time may have already occurred and leveled off.
To our knowledge, there are no studies specifically looking at the timing of onset of drug effect of latanoprost in different age groups. Because of the theoretical plausibility of this effect based on the mechanism of action of latanoprost, this represents an opportunity to further elucidate the characteristics of this medication in a manner which has clinical and scientific relevance.
Our aim is thus to determine if there is a difference in timing of onset of the ocular hypotensive effect of latanoprost in glaucoma patients of different age groups.
- Conditions
- Glaucoma
- Being tested
- Latanoprost 0.005%
- Keywords
- Latanoprost, Glaucoma, Intraocular pressure
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latanoprost 0.005%Drug
Also called Xalatan
Latanoprost 0.005% ophthalmic solution QHS 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | All participants will be taking Latanoprost; This study compares efficacy within age groups. Receives: Drug: Latanoprost 0.005% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Treatment IOP (Intraocular Pressure)
Subjects applied topical latanoprost at bedtime for 8 weeks
Measured: At baseline (before treatment)
Post-Treatment IOP (Intraocular Pressure)
Subjects applied topical latanoprost at bedtime for 8 weeks
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Bruce Shields, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224289
- Sponsor's protocol ID
- 27390
- Status last verified
- Nov 2012
- First submitted
- 16 Sep 2005
- Last updated
- 10 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Age on Efficacy and Response Time of Latanoprost 0.005% in Patients With Glaucoma
- ClinicalTrials.gov ID
- NCT00224289
- Acronym / sponsor ID
- 27390
- Conditions
- Glaucoma
- Keywords
- Latanoprost, Glaucoma, Intraocular pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Mar 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 10 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Latanoprost is a commonly used treatment for glaucoma. Because of its mechanism of action, it is plausible that the age of a patient using the medication may affect its efficacy and time of onset.
We are going to study the effectiveness of Latanoprost in people of different ages, to see if it changes based on the age of the patient.
Detailed description
Latanoprost is a topical ocular hypotensive medication with a well established safety and efficacy profile. Its effect is mediated by an increase in uveoscleral outflow, due to enzymatic degradation of the extracellular matrix within the ciliary muscle. Since the amount of extracellular matrix within the human eye increases with age, and uveoscleral outflow decreases with age, it would be expected that there should be a difference in the efficacy of latanoprost in patients of different ages. This has not been demonstrated in studies assessing the overall effect of latanoprost across adult age groups using multivariate analysis. (Camras CB et al, 1996).
However, a difference in timing of onset of drug effect may get overlooked in clinical studies and in clinical practice as well, as patients tend to be seen from two to eight weeks after initiation of treatment, by which time any differences in response time may have already occurred and leveled off.
To our knowledge, there are no studies specifically looking at the timing of onset of drug effect of latanoprost in different age groups. Because of the theoretical plausibility of this effect based on the mechanism of action of latanoprost, this represents an opportunity to further elucidate the characteristics of this medication in a manner which has clinical and scientific relevance.
Our aim is thus to determine if there is a difference in timing of onset of the ocular hypotensive effect of latanoprost in glaucoma patients of different age groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Latanoprost 0.005%All participants will be taking Latanoprost; This study compares efficacy within age groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of open angle glaucoma,
- pseudoexfoliation glaucoma, pigmentary glaucoma or ocular hypertension in one or both eyes;
- IOP above their target pressure as determined by a glaucoma specialist;
- willingness to participate in the study.
Key exclusion criteria (7 listed)
- hypersensitivity to any of the components of the treatment medication;
- previous use of topical prostaglandins;
- documented ocular infection or intraocular inflammation within the past year;
- previous filtering surgery or complicated cataract surgery;
- active corneal 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 |
|---|---|---|
| Latanoprost 0.005%Also: XalatanLatanoprost 0.005% ophthalmic solution QHS 8 weeks | Drug | 1 |
Primary outcome
Pre-Treatment IOP (Intraocular Pressure)
Time frame: At baseline (before treatment)
Subjects applied topical latanoprost at bedtime for 8 weeks
Post-Treatment IOP (Intraocular Pressure)
Time frame: 8 Weeks
Subjects applied topical latanoprost at bedtime for 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bruce Shields, MD principal investigator
Yale University
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 Latanoprost 0.005% in people with Glaucoma, run by Yale University at 1 site in United States.
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 7 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 10 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 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 10 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pre-Treatment IOP (Intraocular Pressure) (time frame: At baseline (before treatment)). The study lists 2 primary outcomes in all. 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 10 Dec 2012.