Ocular HypertensionGASNCT00680329
Glaucoma Adherence Study, Spain
An observational study of Ocular Hypertension and Primary Open Angle Glaucoma, run by Alcon Research at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate adherence to DuoTrav® when reinforced by the use of the Travalert™ Dosing Aid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Primary Open Angle Glaucoma
- What is being tested?
- Travoprost 0.004%/timolol 0.05% fixed combination eye drops (DuoTrav) and Travalert Dosing Aid
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteSpain
- Study dates
- May 2008to Jul 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were selected from one study site in Spain.
Who may be able to join
- Provide informed consent.
- Able to follow instructions and be willing and able to attend required study visits.
- Able to read and complete study questionnaires.
- Clinical diagnosis of ocular hypertension, or primary open-angle, pigment dispersion or exfoliation glaucoma in at least one eye.
- Intraocular pressure considered safe, in both eyes, assuring clinical stability of vision and the optic nerve throughout the trial.
- Currently treated with DuoTrav alone, dosed in the evening for at least for 30 days, at Visit 1.
Show all 11Show fewer
- Best corrected visual acuity of 20/200 Snellen or better in each eye.
- Intraocular pressure ≤ 30 mm Hg in both eyes.
- Evidence causing the investigator to consider the patient to be non-adherent, at some level, to their glaucoma medication.
- Agree that their adherence could be improved by the intervention with the dosing aid described in this study.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Presence of other primary or secondary glaucoma not listed in inclusion criterion.
- Any abnormality preventing reliable applanation tonometry in the study eye(s).
- Any known opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of the study eye(s).
- Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
- Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to Visit 1.
- Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment.
Show all 17Show fewer
- Progressive retinal or optic nerve disease from any cause.
- Women of childbearing potential not using reliable means of birth control.
- Women who are pregnant or lactating.
- A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient.
- Participation in any other investigational study within 30 days prior to Visit 1.
- Known medical history of allergy, sensitivity or poor tolerance to any components of the preparations to be used in this trial that is deemed clinically significant in the opinion of the Principal Investigator.
- Unwillingness to risk the possibility of darkened irides, eyelash changes or periocular pigmentation.
- History of, or at risk for uveitis or cystoid macular edema (CME).
- Any physical disability which prevents the accurate use of the Travalert™ dosing aid.
- Unable to accurately instill the travoprost/timolol fixed combination in the evening.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Adherence Assessment With the Travalert™ Dosing Aid in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma Who Are Treated With the Travoprost/Timolol Maleate Fixed Combination Every Evening
The purpose of this study is to evaluate adherence to DuoTrav® when reinforced by the use of the Travalert™ Dosing Aid.
Read the detailed description
This study was conducted in Spain. An identical study was conducted in France, UK, Italy, and Netherlands under Protocol ID EMD-07-01. A combined enrollment number is presented.
- Conditions
- Ocular Hypertension, Primary Open Angle Glaucoma
- Being tested
- Travoprost 0.004%/timolol 0.05% fixed combination eye drops (DuoTrav), Travalert Dosing Aid
- Keywords
- Adherence, Compliance, Glaucoma, Ocular Hypertension
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle, Patient Compliance, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travoprost 0.004%/timolol 0.05% fixed combination eye drops (DuoTrav)Drug
Also called DuoTrav
One drop in study eye(s) once daily in the evening for four months
Travalert Dosing AidDevice
Approved device used with DuoTrav and intended to provide an objective system for quantifying dosing and improving patient adherence
| Study group | Role | What they receive |
|---|---|---|
| Travalert with DuoTrav | One drop in study eye(s) once daily in the evening for four months Receives: Drug: Travoprost 0.004%/timolol 0.05% fixed combination eye drops (DuoTrav); Device: Travalert Dosing Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in Intraocular Pressure at 4 months
As measured by Goldmann Applanation tonometry
Measured: Baseline, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680329
- Sponsor's protocol ID
- EMD-07-02
- Other IDs
- EMD-07-01
- Acronym
- GAS
- Status last verified
- May 2012
- First submitted
- 16 May 2008
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Adherence Assessment With the Travalert™ Dosing Aid in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma Who Are Treated With the Travoprost/Timolol Maleate Fixed Combination Every Evening
- ClinicalTrials.gov ID
- NCT00680329
- Acronym / sponsor ID
- GAS / EMD-07-02
- Conditions
- Ocular Hypertension, Primary Open Angle Glaucoma
- Keywords
- Adherence, Compliance, Glaucoma, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 20 May 2008 (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.
The purpose of this study is to evaluate adherence to DuoTrav® when reinforced by the use of the Travalert™ Dosing Aid.
Detailed description
This study was conducted in Spain. An identical study was conducted in France, UK, Italy, and Netherlands under Protocol ID EMD-07-01. A combined enrollment number is presented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Travalert with DuoTrav | – | Drug: Travoprost 0.004%/timolol 0.05% fixed combination eye drops (DuoTrav), Device: Travalert Dosing AidOne drop in study eye(s) once daily in the evening for four months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were selected from one study site in Spain.
Key inclusion criteria (11 listed)
- Provide informed consent.
- Able to follow instructions and be willing and able to attend required study visits.
- Able to read and complete study questionnaires.
- Clinical diagnosis of ocular hypertension, or primary open-angle, pigment dispersion or exfoliation glaucoma in at least one eye.
- Intraocular pressure considered safe, in both eyes, assuring clinical stability of vision and the optic nerve throughout the trial.
Key exclusion criteria (17 listed)
- Presence of other primary or secondary glaucoma not listed in inclusion criterion.
- Any abnormality preventing reliable applanation tonometry in the study eye(s).
- Any known opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of the study eye(s).
- Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
- Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to Visit 1.
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 0.004%/timolol 0.05% fixed combination eye drops (DuoTrav)Also: DuoTravOne drop in study eye(s) once daily in the evening for four months | Drug | Travalert with DuoTrav |
| Travalert Dosing AidApproved device used with DuoTrav and intended to provide an objective system for quantifying dosing and improving patient adherence | Device | Travalert with DuoTrav |
Primary outcome
Mean Change from Baseline in Intraocular Pressure at 4 months
Time frame: Baseline, 4 months
As measured by Goldmann Applanation tonometry
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 31 May 2012.
Related trials for Ocular Hypertension
Recruiting
Timing of Glaucoma Drainage Device With Boston Keratoprosthesis
Corneal Transplantation, Glaucoma
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Not yet recruitingPhase 2
VGFTe-(HD)-OD-2566: Adjunctive Aflibercept Ahmed Glaucoma Valve (AAA) Study
Glaucoma
Recruiting
Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears)
Glaucoma, Corneal Transplantation
RecruitingPhase 1/2
A Study About the Safety of ASP2767 and Whether it Helps People With Glaucoma-Related Optic Nerve Damage
Glaucoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ocular Hypertension and Primary Open Angle Glaucoma, run by Alcon Research at 1 site in Spain.
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 11 inclusion and 17 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 31 May 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 Spain. 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.
What does the primary outcome measure?
Mean Change from Baseline in Intraocular Pressure at 4 months (time frame: Baseline, 4 months). 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 31 May 2012.