GlaucomaPhase 4NCT00329095
An Evaluation of Use of Topical Ocular Hypotensive Medication by Compliance
A Phase 4 study testing travoprost, latanoprost, or bimatoprost and Additional ocular hypotensive medication in people with Glaucoma and Ocular Hypertension, run by Robin, Alan L., M.D..
Trial summary
This is an open-label study in patients who are currently using either a topical prostaglandin as sole ocular hypotensive medical therapy q.d., or a topical prostaglandin plus an adjunctive topical ocular hypotensive marketed product either q.d., or b.i.d. in the same eye(s). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- travoprost, latanoprost, or bimatoprost and Additional ocular hypotensive medication
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Apr 2006
- 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
- Currently using one or two topical ocular hypotensive medications
Who cannot join
- Hypersensitivity to any component of medication
About this study
Official title: An Evaluation of Use of Topical Ocular Hypotensive Medication by Electronic Compliance Measures
This is an open-label study in patients who are currently using either a topical prostaglandin as sole ocular hypotensive medical therapy q.d., or a topical prostaglandin plus an adjunctive topical ocular hypotensive marketed product either q.d., or b.i.d. in the same eye(s). Compliance will be measured over the two months of participation.
Read the detailed description
This is an open-label study in patients who are currently using either a topical prostaglandin as sole ocular hypotensive medical therapy q.d., or a topical prostaglandin plus an adjunctive topical ocular hypotensive marketed product either q.d., or b.i.d. in the same eye(s). Compliance will be measured over the two months of participation.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- travoprost, latanoprost, or bimatoprost, Additional ocular hypotensive medication
- Keywords
- Glaucoma, Compliance
- Medical subject headings
- Glaucoma, Ocular Hypertension, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
travoprost, latanoprost, or bimatoprostDrug
Additional ocular hypotensive medicationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startDec 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Robin, Alan L., M.D.
- Investigators
- Alan L. Robin, MD, Principal investigator, Alan L. Robin, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329095
- Sponsor's protocol ID
- GMED-01
- Status last verified
- May 2006
- First submitted
- 19 May 2006
- Last updated
- 24 May 2006
- Results posted
- No
Publications
Robin AL, Novack GD, Covert DW, Crockett RS, Marcic TS. Adherence in glaucoma: objective measurements of once-daily and adjunctive medication use. Am J Ophthalmol. 2007 Oct;144(4):533-40. doi: 10.1016/j.ajo.2007.06.012. Epub 2007 Aug 8.
PubMed 17686450
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Use of Topical Ocular Hypotensive Medication by Electronic Compliance Measures
- ClinicalTrials.gov ID
- NCT00329095
- Acronym / sponsor ID
- GMED-01
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Compliance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Robin, Alan L., M.D.
- Study start
- Dec 2005
- Study completion
- Apr 2006
- First posted
- 24 May 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.
This is an open-label study in patients who are currently using either a topical prostaglandin as sole ocular hypotensive medical therapy q.d., or a topical prostaglandin plus an adjunctive topical ocular hypotensive marketed product either q.d., or b.i.d. in the same eye(s). Compliance will be measured over the two months of participation.
Detailed description
This is an open-label study in patients who are currently using either a topical prostaglandin as sole ocular hypotensive medical therapy q.d., or a topical prostaglandin plus an adjunctive topical ocular hypotensive marketed product either q.d., or b.i.d. in the same eye(s). Compliance will be measured over the two months of participation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Currently using one or two topical ocular hypotensive medications
Key exclusion criteria (1 listed)
- Hypersensitivity to any component of medication
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 |
|---|---|---|
| travoprost, latanoprost, or bimatoprost | Drug | – |
| Additional ocular hypotensive medication | Drug | – |
Primary outcome
Compliance.
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 24 May 2006.
- Derived from this study: PubMed 17686450Robin AL, Novack GD, Covert DW, Crockett RS, Marcic TS. Adherence in glaucoma: objective measurements of once-daily and adjunctive medication use. Am J Ophthalmol. 2007 Oct;144(4):533-40. doi: 10.1016/j.ajo.2007.06.012. Epub 2007 Aug 8.
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
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.
Alan L. Robin, MD principal investigator
Alan L. Robin, M.D.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing travoprost, latanoprost, or bimatoprost and Additional ocular hypotensive medication in people with Glaucoma and Ocular Hypertension, run by Robin, Alan L., M.D..
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 1 inclusion and 1 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 24 May 2006. Status can change between updates, so confirm with the study contact before making plans.
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?
Compliance.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00329095, which also lists 1 linked publication.
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 24 May 2006.