Open Angle GlaucomaPhase 4NCT00539526
Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues
A Phase 4 study testing Bimatoprost 0.03%, travoprost 0.004% and latanoprost 0.005% eye drops in people with Open Angle Glaucoma and Ocular Hypertension, run by Allergan at 1 site in United States.
Trial summary
This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues 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?
- Bimatoprost 0.03%, travoprost 0.004% and latanoprost 0.005% eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2008
- 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
- Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension
Who cannot join
- Known contraindication to latanoprost, bimatoprost or travoprost
- Uncontrolled systemic disease
- Active ocular disease other than glaucoma or ocular hypertension
- Pregnant or lactating women or women of childbearing potential NOT utilizing a medically acceptable form of birth control
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Bimatoprost 0.03%, travoprost 0.004%, latanoprost 0.005% eye drops
- 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.
Bimatoprost 0.03%Drug
Also called Lumigan®
bimatoprost 0.03%, 1 drop nightly for 3 months
travoprost 0.004%Drug
Also called Travatan® Z
travoprost 0.004% eye drops, 1 drop nightly for 3 months
latanoprost 0.005% eye dropsDrug
Also called Xalatan®
latanoprost 0.005%, 1 drop nightly for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | bimatoprost 0.03% Receives: Drug: Bimatoprost 0.03% |
| 2 | Active comparator | travoprost 0.004% Receives: Drug: travoprost 0.004% |
| 3 | Active comparator | latanoprost 0.005% Receives: Drug: latanoprost 0.005% eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3
Change from baseline in mean conjunctival hyperemia scores at month 3. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded using a 5-point scale in which 0=no redness and +3=deep, diffuse redness. A negative number change from baseline indicates improvement.
Measured: Baseline, Month 3
Secondary outcomes (2)
Change From Baseline in Corneal Staining With Fluorescein at Month 3
Change from baseline in corneal staining with fluorescein at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0 equals no puncta (best), and 3 equals too many puncta to count (worst). A negative number change from baseline indicates improvement.
Measured: Baseline, Month 3
Change From Baseline in Tear Break-Up Time (TBUT) at Month 3
Change from baseline in TBUT at month 3. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionJul 2008
- Study completionSep 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Angle GlaucomaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539526
- Sponsor's protocol ID
- MA-LUM-07-003
- Status last verified
- Apr 2019
- First submitted
- 2 Oct 2007
- Last updated
- 24 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Whitson JT, Trattler WB, Matossian C, Williams J, Hollander DA. Ocular surface tolerability of prostaglandin analogs in patients with glaucoma or ocular hypertension. J Ocul Pharmacol Ther. 2010 Jun;26(3):287-92. doi: 10.1089/jop.2009.0134.
PubMed 20578283
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues
- ClinicalTrials.gov ID
- NCT00539526
- Acronym / sponsor ID
- MA-LUM-07-003
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 4 Oct 2007 (estimated)
- Results
- Posted 31 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bimatoprost 0.03%bimatoprost 0.03% |
| 2 | Active comparator | Drug: travoprost 0.004%travoprost 0.004% |
| 3 | Active comparator | Drug: latanoprost 0.005% eye dropslatanoprost 0.005% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension
Key exclusion criteria (4 listed)
- Known contraindication to latanoprost, bimatoprost or travoprost
- Uncontrolled systemic disease
- Active ocular disease other than glaucoma or ocular hypertension
- Pregnant or lactating women or women of childbearing potential NOT utilizing a medically acceptable form of birth control
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 |
|---|---|---|
| Bimatoprost 0.03%Also: Lumigan®bimatoprost 0.03%, 1 drop nightly for 3 months | Drug | 1 |
| travoprost 0.004%Also: Travatan® Ztravoprost 0.004% eye drops, 1 drop nightly for 3 months | Drug | 2 |
| latanoprost 0.005% eye dropsAlso: Xalatan®latanoprost 0.005%, 1 drop nightly for 3 months | Drug | 3 |
Primary outcome
Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3
Time frame: Baseline, Month 3
Change from baseline in mean conjunctival hyperemia scores at month 3. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded using a 5-point scale in which 0=no redness and +3=deep, diffuse redness. A negative number change from baseline indicates improvement.
2 secondary outcomes
Change From Baseline in Corneal Staining With Fluorescein at Month 3
Time frame: Baseline, Month 3
Change From Baseline in Tear Break-Up Time (TBUT) at Month 3
Time frame: Baseline, Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20578283Whitson JT, Trattler WB, Matossian C, Williams J, Hollander DA. Ocular surface tolerability of prostaglandin analogs in patients with glaucoma or ocular hypertension. J Ocul Pharmacol Ther. 2010 Jun;26(3):287-92. doi: 10.1089/jop.2009.0134.
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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.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bimatoprost 0.03%, travoprost 0.004% and latanoprost 0.005% eye drops in people with Open Angle Glaucoma and Ocular Hypertension, run by Allergan 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 1 inclusion and 4 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 24 Apr 2019. 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. 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 31 Oct 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?
Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3 (time frame: Baseline, Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00539526, which also lists 1 linked publication.
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 24 Apr 2019.