Open-angle Glaucoma (OAG)Phase 2NCT01114893
Travoprost Five Day Posology Study
A Phase 2 study testing Travoprost 0.004% and Travoprost (Groups A, B and C) in people with Open-angle Glaucoma (OAG) and Ocular Hypertension, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of three concentrations of travoprost ophthalmic solution (Groups A, B and C) administered eight times daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma (OAG), Ocular Hypertension
- What is being tested?
- Travoprost 0.004% and Travoprost (Groups A, B and C)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to May 2010
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- either sex and any race/ethnicity, ≥18 years old
- diagnosed with open-angle glaucoma, and/or ocular hypertension
- meets the following IOP entry criteria:
- Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
- Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
- satisfies all informed consent requirements; able to read, sign and date the informed consent
Who cannot join
- females of childbearing potential not meeting protocol conditions
- angle grade less than Grade 2 in either eye
- cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
- severe central visual field loss in either eye
- any abnormality preventing reliable applanation tonometry in either eye
- hypersensitivity to prostaglandin analogues or to any component of the study medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, 76134
About this study
The purpose of this study is to determine the safety and efficacy of three concentrations of travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.
- Conditions
- Open-angle Glaucoma (OAG), Ocular Hypertension
- Being tested
- Travoprost 0.004%, Travoprost Vehicle, Travoprost (Groups A, B and C)
- 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 0.004%Drug
1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days
Travoprost VehicleDrug
1 drop in each eye 8 times daily for 5 days
Travoprost (Groups A, B and C)Drug
1 drop in each eye 8 times daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| TRAVATAN | Active comparator | TRAVATAN 0.004% once daily Receives: Drug: Travoprost 0.004% |
| Travoprost Vehicle | Placebo comparator | Travoprost Vehicle Receives: Drug: Travoprost Vehicle |
| Travoprost Group A | Experimental | Travoprost Group A Receives: Drug: Travoprost (Groups A, B and C) |
| Travoprost Group B | Experimental | Travoprost Group B Receives: Drug: Travoprost (Groups A, B and C) |
| Travoprost Group C | Experimental | Travoprost Group C Receives: Drug: Travoprost (Groups A, B and C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5
Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment
Measured: 5 days
Secondary outcomes (1)
IOP Change From Baseline at 8 PM on Day 5
Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment
Measured: 5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2010
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 Open-angle Glaucoma (OAG)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114893
- Sponsor's protocol ID
- C-09-075
- Status last verified
- May 2011
- First submitted
- 30 Apr 2010
- Last updated
- 23 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Travoprost Five Day Posology Study
- ClinicalTrials.gov ID
- NCT01114893
- Acronym / sponsor ID
- C-09-075
- Conditions
- Open-angle Glaucoma (OAG), Ocular Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- May 2010 (actual)
- First posted
- 3 May 2010 (estimated)
- Results
- Posted 23 Jun 2011
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 determine the safety and efficacy of three concentrations of travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TRAVATAN | Active comparator | Drug: Travoprost 0.004%TRAVATAN 0.004% once daily |
| Travoprost Vehicle | Placebo comparator | Drug: Travoprost VehicleTravoprost Vehicle |
| Travoprost Group A | Experimental | Drug: Travoprost (Groups A, B and C)Travoprost Group A |
| Travoprost Group B | Experimental | Drug: Travoprost (Groups A, B and C)Travoprost Group B |
| Travoprost Group C | Experimental | Drug: Travoprost (Groups A, B and C)Travoprost Group C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- either sex and any race/ethnicity, ≥18 years old
- diagnosed with open-angle glaucoma, and/or ocular hypertension
- meets the following IOP entry criteria:
- satisfies all informed consent requirements; able to read, sign and date the informed consent
Key exclusion criteria (6 listed)
- females of childbearing potential not meeting protocol conditions
- angle grade less than Grade 2 in either eye
- cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
- severe central visual field loss in either eye
- any abnormality preventing reliable applanation tonometry 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 0.004%1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days | Drug | TRAVATAN |
| Travoprost Vehicle1 drop in each eye 8 times daily for 5 days | Drug | Travoprost Vehicle |
| Travoprost (Groups A, B and C)1 drop in each eye 8 times daily for 5 days | Drug | Travoprost Group A, Travoprost Group B, Travoprost Group C |
Primary outcome
Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5
Time frame: 5 days
Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment
1 secondary outcome
IOP Change From Baseline at 8 PM on Day 5
Time frame: 5 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
- 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.
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?
A Phase 2 study testing Travoprost 0.004% and Travoprost (Groups A, B and C) in people with Open-angle Glaucoma (OAG) and Ocular Hypertension, run by Alcon Research 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 6 inclusion and 6 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 23 Jun 2011. 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. 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?
Yes. Results are posted in the registry (first posted 23 Jun 2011). 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?
Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5 (time frame: 5 days). 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 23 Jun 2011.