Ocular HypertensionPhase 2NCT00670033
Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension
A Phase 2 study testing Travoprost ophthalmic solution (new formulation) and Travoprost ophthalmic solution, 0.004% in people with Ocular Hypertension and Open-angle Glaucoma, run by Alcon Research.
Trial summary
The purpose of this study was to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Open-angle Glaucoma
- What is being tested?
- Travoprost ophthalmic solution (new formulation) and Travoprost ophthalmic solution, 0.004%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Sep 2008
- 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
- Satisfy all informed consent requirements;
- Diagnosed with open-angle glaucoma or ocular hypertension;
- Able to discontinue use of all IOP-lowering medications for a minimum of 5 to 28 days prior to the Eligibility 1 Visit;
- IOP measurements in at least 1 eye as specified in protocol;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Females of childbearing potential if pregnant, breastfeeding, or not using highly effective birth control measures;
- Any form of glaucoma other than open-angle glaucoma;
- Severe central visual field loss in either eye;
- Chronic, recurrent or severe inflammatory eye disease;
- Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment, in the opinion of the Investigator;
- Best-corrected visual acuity (BCVA) worse than 0.60 logarithm of the miniminum angle of resolution (logMAR);
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- Intraocular surgery within the past 6 months;
- Ocular laser surgery within the past 3 months;
- Any abnormality preventing reliable applanation tonometry;
- Severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study;
- Other protocol-specified exclusion criteria may apply.
About this study
Official title: Comparison of Safety and IOP-Lowering Efficacy of Three Alternative Travoprost Formulations to Vehicle and TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension
The purpose of this study was to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or ocular hypertension.
- Conditions
- Ocular Hypertension, Open-angle Glaucoma
- Being tested
- Travoprost ophthalmic solution (new formulation), Travoprost ophthalmic solution, 0.004%, Vehicle
- Keywords
- IOP, Open-angle glaucoma, Ocular Hypertension
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travoprost ophthalmic solution (new formulation)Drug
Travoprost ophthalmic solution, 0.004%Drug
Also called TRAVATAN®, TRAVATAN Z®
VehicleDrug
Inactive ingredients used as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Travoprost new formulation | Experimental | Travoprost ophthalmic solution (new formulation), 1 of 3 dose levels, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks Receives: Drug: Travoprost ophthalmic solution (new formulation) |
| TRAVATAN | Active comparator | Travoprost ophthalmic solution 0.004%, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks Receives: Drug: Travoprost ophthalmic solution, 0.004% |
| Vehicle | Placebo comparator | Inactive ingredients, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in intraocular pressure (IOP)
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.
Measured: Baseline, Up to Week 4
Secondary outcomes (2)
Mean intraocular pressure
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Measured: Baseline, Up to Week 4
Mean percent change from baseline in IOP
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change indicates a greater amount of improvement.
Measured: Baseline, Up to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2008
- Study completionSep 2008
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.
- 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
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theresa Landry, PhD, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670033
- Sponsor's protocol ID
- C-07-46
- Status last verified
- Jun 2014
- First submitted
- 29 Apr 2008
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and IOP-Lowering Efficacy of Three Alternative Travoprost Formulations to Vehicle and TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00670033
- Acronym / sponsor ID
- C-07-46
- Conditions
- Ocular Hypertension, Open-angle Glaucoma
- Keywords
- IOP, Open-angle glaucoma, Ocular Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 1 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 was to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Travoprost new formulation | Experimental | Drug: Travoprost ophthalmic solution (new formulation)Travoprost ophthalmic solution (new formulation), 1 of 3 dose levels, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks |
| TRAVATAN | Active comparator | Drug: Travoprost ophthalmic solution, 0.004%Travoprost ophthalmic solution 0.004%, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks |
| Vehicle | Placebo comparator | Drug: VehicleInactive ingredients, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Satisfy all informed consent requirements;
- Diagnosed with open-angle glaucoma or ocular hypertension;
- Able to discontinue use of all IOP-lowering medications for a minimum of 5 to 28 days prior to the Eligibility 1 Visit;
- IOP measurements in at least 1 eye as specified in protocol;
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (11 listed)
- Females of childbearing potential if pregnant, breastfeeding, or not using highly effective birth control measures;
- Any form of glaucoma other than open-angle glaucoma;
- Severe central visual field loss in either eye;
- Chronic, recurrent or severe inflammatory eye disease;
- Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment, in the opinion of the Investigator;
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 (new formulation) | Drug | Travoprost new formulation |
| Travoprost ophthalmic solution, 0.004%Also: TRAVATAN®, TRAVATAN Z® | Drug | TRAVATAN |
| VehicleInactive ingredients used as a placebo | Drug | Vehicle |
Primary outcome
Mean change from baseline in intraocular pressure (IOP)
Time frame: Baseline, Up to Week 4
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.
2 secondary outcomes
Mean intraocular pressure
Time frame: Baseline, Up to Week 4
Mean percent change from baseline in IOP
Time frame: Baseline, Up to Week 4
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 10 Jul 2014.
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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.
Theresa Landry, PhD study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Travoprost ophthalmic solution (new formulation) and Travoprost ophthalmic solution, 0.004% in people with Ocular Hypertension and Open-angle Glaucoma, 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 11 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 Jul 2014. 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?
Mean change from baseline in intraocular pressure (IOP) (time frame: Baseline, Up to Week 4). 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 Jul 2014.