Open-angle GlaucomaPhase 2NCT01298687
Divided Dose of TRAVATAN®
A Phase 2 study testing Travoprost Ophthalmic Solution, 0.00013%, Travoprost Ophthalmic Solution, 0.00033% and Travoprost Ophthalmic Solution, 0.001% in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research.
Trial summary
The purpose of this study is to compare the incremental dosing of travoprost ophthalmic solution versus once a day dosing of TRAVATAN® in lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma, Ocular Hypertension
- What is being tested?
- Travoprost Ophthalmic Solution, 0.00013%, Travoprost Ophthalmic Solution, 0.00033% and Travoprost Ophthalmic Solution, 0.001%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Apr 2011
- Phase
- Phase 2
- 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
- Patients with open-angle glaucoma or ocular hypertension who meet the following IOP criteria:
- Mean IOP ≥ 24 mmHg in at least 1 eye, with the same eye qualifying at 8 AM at both Day 0 and Day 1;
- Mean IOP ≤ 36 mmHg in both eyes at all time points on Day 0 and Day 1.
- Must sign an informed consent form.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Females of childbearing potential who are pregnant, test positive on urine pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast-feeding, or are not using highly effective birth control measures.
- Current or history of ocular inflammation or infection in either eye within the past 3 months.
- Corneal thickness greater than 620 µm as determined by pachymetry in either eye.
- Severe visual field loss.
- Cup to disc ratio greater than 0.8 in either eye.
- Intraocular surgery within the past 6 months in either eye.
- Other protocol-defined exclusion criteria may apply.
About this study
The purpose of this study is to compare the incremental dosing of travoprost ophthalmic solution versus once a day dosing of TRAVATAN® in lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Being tested
- Travoprost Ophthalmic Solution, 0.00013%, Travoprost Ophthalmic Solution, 0.00033%, Travoprost Ophthalmic Solution, 0.001%, Travoprost Ophthalmic Solution, 0.00267%, Travoprost Ophthalmic Solution, 0.004%
- Keywords
- open-angle glaucoma, ocular hypertension, divided dose
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travoprost Ophthalmic Solution, 0.00013%Drug
Cumulative daily dose is below the travoprost ophthalmic solution, 0.004% once daily dose
Travoprost Ophthalmic Solution, 0.00033%Drug
Cumulative daily dose equals the travoprost ophthalmic solution, 0.004% once daily dose
Travoprost Ophthalmic Solution, 0.001%Drug
Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
Travoprost Ophthalmic Solution, 0.00267%Drug
Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
Travoprost Ophthalmic Solution, 0.004%Drug
Also called TRAVATAN®
Travoprost VehicleDrug
Inactive ingredients used as an active comparator
| Study group | Role | What they receive |
|---|---|---|
| Trav 0.00013% | Experimental | Travoprost Ophthalmic Solution, 0.00013%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days Receives: Drug: Travoprost Ophthalmic Solution, 0.00013% |
| Trav 0.00033% | Experimental | Travoprost Ophthalmic Solution, 0.00033%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days Receives: Drug: Travoprost Ophthalmic Solution, 0.00033% |
| Trav 0.001% | Experimental | Travoprost Ophthalmic Solution, 0.001%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days Receives: Drug: Travoprost Ophthalmic Solution, 0.001% |
| Trav 0.00267% | Experimental | Travoprost Ophthalmic Solution, 0.00267%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days Receives: Drug: Travoprost Ophthalmic Solution, 0.00267% |
| TRAVATAN | Active comparator | Travoprost Ophthalmic Solution, 0.004%, 1 drop administered in each eye at 8 pm for 5 days, with 1 drop of vehicle administered at all other timepoints (2-hour intervals) Receives: Drug: Travoprost Ophthalmic Solution, 0.004% |
| Vehicle | Placebo comparator | Travoprost vehicle, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days Receives: Drug: Travoprost Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour Area Under the Curve (AUC) in IOP Reduction
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matt Walker, PhD, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298687
- Sponsor's protocol ID
- C-10-081
- Status last verified
- Jul 2014
- First submitted
- 16 Feb 2011
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Divided Dose of TRAVATAN®
- ClinicalTrials.gov ID
- NCT01298687
- Acronym / sponsor ID
- C-10-081
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Keywords
- open-angle glaucoma, ocular hypertension, divided dose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 18 Feb 2011 (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 compare the incremental dosing of travoprost ophthalmic solution versus once a day dosing of TRAVATAN® in lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Trav 0.00013% | Experimental | Drug: Travoprost Ophthalmic Solution, 0.00013%Travoprost Ophthalmic Solution, 0.00013%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days |
| Trav 0.00033% | Experimental | Drug: Travoprost Ophthalmic Solution, 0.00033%Travoprost Ophthalmic Solution, 0.00033%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days |
| Trav 0.001% | Experimental | Drug: Travoprost Ophthalmic Solution, 0.001%Travoprost Ophthalmic Solution, 0.001%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days |
| Trav 0.00267% | Experimental | Drug: Travoprost Ophthalmic Solution, 0.00267%Travoprost Ophthalmic Solution, 0.00267%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days |
| TRAVATAN | Active comparator | Drug: Travoprost Ophthalmic Solution, 0.004%Travoprost Ophthalmic Solution, 0.004%, 1 drop administered in each eye at 8 pm for 5 days, with 1 drop of vehicle administered at all other timepoints (2-hour intervals) |
| Vehicle | Placebo comparator | Drug: Travoprost VehicleTravoprost vehicle, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with open-angle glaucoma or ocular hypertension who meet the following IOP criteria:
- Must sign an informed consent form.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (7 listed)
- Females of childbearing potential who are pregnant, test positive on urine pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast-feeding, or are not using highly effective birth control measures.
- Current or history of ocular inflammation or infection in either eye within the past 3 months.
- Corneal thickness greater than 620 µm as determined by pachymetry in either eye.
- Severe visual field loss.
- Cup to disc ratio greater than 0.8 in either eye.
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 Ophthalmic Solution, 0.00013%Cumulative daily dose is below the travoprost ophthalmic solution, 0.004% once daily dose | Drug | Trav 0.00013% |
| Travoprost Ophthalmic Solution, 0.00033%Cumulative daily dose equals the travoprost ophthalmic solution, 0.004% once daily dose | Drug | Trav 0.00033% |
| Travoprost Ophthalmic Solution, 0.001%Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose | Drug | Trav 0.001% |
| Travoprost Ophthalmic Solution, 0.00267%Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose | Drug | Trav 0.00267% |
| Travoprost Ophthalmic Solution, 0.004%Also: TRAVATAN® | Drug | TRAVATAN |
| Travoprost VehicleInactive ingredients used as an active comparator | Drug | Vehicle |
Primary outcome
24-hour Area Under the Curve (AUC) in IOP Reduction
Time frame: Day 5
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 5 May 2017.
Related trials for Open-angle Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle 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.
Matt Walker, PhD study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Travoprost Ophthalmic Solution, 0.00013%, Travoprost Ophthalmic Solution, 0.00033% and Travoprost Ophthalmic Solution, 0.001% in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research.
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 5 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 5 May 2017. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
24-hour Area Under the Curve (AUC) in IOP Reduction (time frame: Day 5). 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 May 2017.