GlaucomaPhase 4NCT01664039
An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®
A Phase 4 study testing Travoprost 0.004% ophthalmic solution and Bimatoprost 0.01% ophthalmic solution in people with Glaucoma and Ocular Hypertension, run by Alcon Research.
Trial summary
The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular pressure (IOP) and ocular surface and inflammatory biomarkers. 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 0.004% ophthalmic solution and Bimatoprost 0.01% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Jun 2014
- Phase
- Phase 4
- 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
- Diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment.
- Intraocular pressure (IOP) between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye.
- IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
- Able to follow instructions and be willing and able to attend all study visits.
- Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye.
- Must read, sign, and date an Ethics Committee-approved informed consent form.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Known medical history of allergy, hypersensitivity or poor tolerance to any components of the study medications to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
- Any abnormality preventing reliable applanation tonometry in either eye.
- Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
- Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids.
- History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications).
- Contact lens wear.
Show all 12Show fewer
- Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
- Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
- Women of childbearing potential not using reliable means of birth control, are pregnant, or lactating.
- Unwilling to risk the possibility of darkened iris or eyelash changes.
- Participation in any other investigational study within 30 days prior to the Screening Visit.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Assessing the Efficacy and Tolerability of TRAVATAN® Solution Without BAK, Containing Polyquad® Preservative (Travoprost 0.004%) Versus LUMIGAN® 0.01% Solution With BAK (Bimatoprost 0.01%) in Treatment Naïve Patients With Ocular Hypertension or Open Angle Glaucoma
The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular pressure (IOP) and ocular surface and inflammatory biomarkers.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Travoprost 0.004% ophthalmic solution, Bimatoprost 0.01% ophthalmic solution
- Keywords
- Glaucoma, Ocular hypertension
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travoprost 0.004% ophthalmic solutionDrug
Also called TRAVATAN®
Ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative
Bimatoprost 0.01% ophthalmic solutionDrug
Also called LUMIGAN®
Ophthalmic solution containing benzalkonium chloride (BAK)
| Study group | Role | What they receive |
|---|---|---|
| TRAVATAN | Experimental | Travoprost 0.004% ophthalmic solution with Polyquad®, 1 drop to the study eye(s), once a day in the evening, for 6 months Receives: Drug: Travoprost 0.004% ophthalmic solution |
| LUMIGAN | Active comparator | Bimatoprost 0.01% ophthalmic solution with BAK, 1 drop to the study eye(s), once a day in the evening, for 6 months Receives: Drug: Bimatoprost 0.01% ophthalmic solution |
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) at Month 6
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
Measured: Baseline (Day 0), Month 6
Secondary outcomes (7)
Mean Change From Baseline in IOP at Week 6 and Month 3
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
Measured: Baseline (Day 0), Week 6, Month 3
Percentage of Subjects Who Reached Target IOP at Each Visit
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
Measured: Week 6, Month 3, Month 6
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit
Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
Measured: Baseline (Day 0), Week 6, Month 3, Month 6
Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6
Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
Measured: Baseline (Day 0), Month 3, Month 6
Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6
Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
Measured: Baseline (Day 0), Month 3, Month 6
Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6
The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is "None of the time" and 4 is "All of the time." A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health.
Measured: Baseline (Day 0), Month 3, Month 6
Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6
TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
Measured: Baseline (Day 0), Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionJun 2014
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 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
- NCT01664039
- Sponsor's protocol ID
- RDG-11-244
- Other IDs
- 2012-002078-30
- Status last verified
- Jul 2015
- First submitted
- 10 Aug 2012
- Last updated
- 3 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy and Tolerability of TRAVATAN® Solution Without BAK, Containing Polyquad® Preservative (Travoprost 0.004%) Versus LUMIGAN® 0.01% Solution With BAK (Bimatoprost 0.01%) in Treatment Naïve Patients With Ocular Hypertension or Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT01664039
- Acronym / sponsor ID
- RDG-11-244
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Ocular hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Aug 2012 (estimated)
- Results
- Posted 14 Jul 2015
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 evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular pressure (IOP) and ocular surface and inflammatory biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRAVATAN | Experimental | Drug: Travoprost 0.004% ophthalmic solutionTravoprost 0.004% ophthalmic solution with Polyquad®, 1 drop to the study eye(s), once a day in the evening, for 6 months |
| LUMIGAN | Active comparator | Drug: Bimatoprost 0.01% ophthalmic solutionBimatoprost 0.01% ophthalmic solution with BAK, 1 drop to the study eye(s), once a day in the evening, for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment.
- Intraocular pressure (IOP) between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye.
- IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
- Able to follow instructions and be willing and able to attend all study visits.
- Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye.
Key exclusion criteria (12 listed)
- Known medical history of allergy, hypersensitivity or poor tolerance to any components of the study medications to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
- Any abnormality preventing reliable applanation tonometry in either eye.
- Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
- Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids.
- History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications).
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% ophthalmic solutionAlso: TRAVATAN®Ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative | Drug | TRAVATAN |
| Bimatoprost 0.01% ophthalmic solutionAlso: LUMIGAN®Ophthalmic solution containing benzalkonium chloride (BAK) | Drug | LUMIGAN |
Primary outcome
Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6
Time frame: Baseline (Day 0), Month 6
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
7 secondary outcomes
Mean Change From Baseline in IOP at Week 6 and Month 3
Time frame: Baseline (Day 0), Week 6, Month 3
Percentage of Subjects Who Reached Target IOP at Each Visit
Time frame: Week 6, Month 3, Month 6
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit
Time frame: Baseline (Day 0), Week 6, Month 3, Month 6
Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6
Time frame: Baseline (Day 0), Month 3, Month 6
Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6
Time frame: Baseline (Day 0), Month 3, Month 6
Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6
Time frame: Baseline (Day 0), Month 3, Month 6
Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6
Time frame: Baseline (Day 0), Month 3, Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Travoprost 0.004% ophthalmic solution and Bimatoprost 0.01% ophthalmic solution in people with 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 7 inclusion and 12 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 3 Aug 2015. 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?
Yes. Results are posted in the registry (first posted 14 Jul 2015). 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 Change From Baseline in Intraocular Pressure (IOP) at Month 6 (time frame: Baseline (Day 0), Month 6). 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 3 Aug 2015.