GlaucomaPhase 4BAKNCT01315574
Effects of Anti-Glaucoma Medications on the Ocular Surface
A Phase 4 study testing Travoprost and Latanoprost in people with Glaucoma, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
The purpose of the study is to compare the efficacy of FDA-approved Travoprost (Travatan Z) and Latanoprost (Xalatan)as anti-glaucoma treatment. Several studies indicate that glaucoma medications may be associated with decreased tear production and tear film break-up time (TBUT), and increased inflammatory cells in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Travoprost and Latanoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Dec 2013
- 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
- Subjects must be 18 years of age and may be of any race and either gender;
- Subjects must not have ever used topical prostaglandin anti-glaucomatous therapy;
- Subject has not used anti-glaucomatous treatment in the past 30 days and has not been using prescribed anti-glaucomatous medication for more than 6 months.
- Subject is using other topical anti-glaucomatous topical treatment and wants to switch to a prostaglandin (must have undergone 30 day washout period)
- The IRB Approved informed consent and the privacy document must be read, signed, and dated by the subject or legally authorized representative before enrollment. Additionally, the informed consent document must be signed and dated by the individual consenting the subject, as well as signed and dated by a witness, if applicable;
- Subjects must be generally healthy and have normal ocular health; and
- Subjects must be willing to follow the study procedures and visit schedule.
Who cannot join
- Subjects must not have known sensitivities to any ingredient in any of the test articles
- Subjects must not have any systemic or ocular disease or disorder (exc refractive error), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study:
- No prior (within 30 days of enrollment) or current ocular infections (bacterial, viral or fungal), active ocular inflammation (i.e., follicular conjunctivitis, allergic conjunctivitis, iritis), glaucoma, or preauricular lymphadenopathy.
- No clinically significant lash or lid abnormality (e.g., trichiasis, entropion or ectropion).
- No uncontrolled systemic disease or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis.).
- No prior (within 7 days of enrollment) or current, unstable active illness (e.g., upper respiratory infection).
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- Pregnant woman
- Subjects must not have history of ocular surgery/trauma within the last 6 months
- Subjects must not have used any topical ocular or systemic antibiotics within 30 days of enrollment continuing throughout the study
- Subjects must not have used any topical ocular or systemic corticosteroids within 30 days of enrollment continuing throughout the study
- Subjects must not have used immunomodulator medications within 30 days of enrollment continuing throughout the study
- Subjects must not have a immune cell density of >60/fame present at their baseline confocal scan
- Subjects must not have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
- Inability to cooperate with the confocal exam
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
About this study
Official title: In Vivo Effects of Antiglaucomatous Prostaglandin Therapy on Immune Cells, Epithelium, and Nerves of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study
The purpose of the study is to compare the efficacy of FDA-approved Travoprost (Travatan Z) and Latanoprost (Xalatan)as anti-glaucoma treatment. Several studies indicate that glaucoma medications may be associated with decreased tear production and tear film break-up time (TBUT), and increased inflammatory cells in the conjunctiva (membrane lining of the eye lids and the covering of the eye) leading to dry eye. Normal tear film (coating of the eye) is continuous and blinking maintains the tear film continuity. If you keep your eyes open long enough without blinking, the tear film will start breaking up. Your eye will feel uncomfortable forcing you to blink. In patients with dry eyes, the tear film is unstable, and breaks up faster. Therefore the tear break up time in patients who have dry eyes is shorter.
In this study, the investigators will be comparing the two previously mentioned FDA-approved eye drops Latanoprost and Travoprost. The difference between the two medications is a preservative called benzalkonium chloride (BAK). Latanoprost contains BAK while Travoprost does not. The investigators will be comparing the efficacy of each medication in lowering IOP as well as trying to track the density of immune cells across the corneal surface by taking photos of your eye. The investigators will also be assessing whether either drop leads to symptoms of dry eye by comparing results from ocular surface exam tests such as TBUT.
Read the detailed description
The purpose of the study is to compare the early effects of two anti-glaucoma eye drops on eye pressure and inflammation of the eye using a microscope. One of the eye drops contains a commonly used preservative, benzalkonium chloride (BAK), while the other is free of this preservative, instead it utilises a new ionic buffer system called SofZia. Prolonged use of BAK may be damaging to the eye surface and thus being investigated at a microscopic level in this study.
Specific aims are to assess the in vivo effect of topical BAK-containing and BAK-free prostaglandin analogue anti-glaucoma therapy on intraocular pressure (IOP), as well as on density and morphology of corneal immune cells, epithelial cells and sub-basal nerve plexus.
- Conditions
- Glaucoma
- Being tested
- Travoprost, Latanoprost
- Keywords
- Glaucoma, Xalatan, Travatan Z, Latanoprost, Travoprost, Dry Eye
- Medical subject headings
- Glaucoma, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TravoprostDrug
Also called Travatan Z
One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.
LatanoprostDrug
Also called Xalatan
One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.
| Study group | Role | What they receive |
|---|---|---|
| Latanoprost (Xalatan) | Active comparator | 7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma. Receives: Drug: Latanoprost |
| Travoprost (Travatan Z) | Active comparator | 7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma. Receives: Drug: Travoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness in Lowering Intraocular Pressure
Applanation tonometry will be used to measure patients' intraocular pressure
Measured: At the 6 month follow-up time point
Secondary outcomes (2)
Corneal Fluorescein Staining Score
Corneal Fluorescein Staining score was used in this study to quantify changes in dry eye symptoms. Corneal fluorescein staining scores range from 0 to 4 points: 0=non-staining to 4 =regional whole staining of the cornea. Higher scores indicate worse eye condition.
Measured: At the 6 month follow-up time point
Tear Film Break-Up Time
Tear Film Break-Up Time (TBUT) is a clinical test used to quantify changes in dry eye symptoms. The Tear Film Break-Up time is the number of seconds between the subjects last blink and the detection of the first dry spot in the tear film.
Measured: At the 6 month follow-up time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Slow Enrollment
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Pedram Hamrah, MD, Principal investigator, Mass Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315574
- Sponsor's protocol ID
- 11-007H
- Acronym
- BAK
- Status last verified
- Jan 2015
- First submitted
- 10 Mar 2011
- Last updated
- 16 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Effects of Antiglaucomatous Prostaglandin Therapy on Immune Cells, Epithelium, and Nerves of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study
- ClinicalTrials.gov ID
- NCT01315574
- Acronym / sponsor ID
- BAK / 11-007H
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Xalatan, Travatan Z, Latanoprost, Travoprost, Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Enrollment
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Feb 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Posted 3 Feb 2017
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 the study is to compare the efficacy of FDA-approved Travoprost (Travatan Z) and Latanoprost (Xalatan)as anti-glaucoma treatment. Several studies indicate that glaucoma medications may be associated with decreased tear production and tear film break-up time (TBUT), and increased inflammatory cells in the conjunctiva (membrane lining of the eye lids and the covering of the eye) leading to dry eye. Normal tear film (coating of the eye) is continuous and blinking maintains the tear film continuity. If you keep your eyes open long enough without blinking, the tear film will start breaking up. Your eye will feel uncomfortable forcing you to blink. In patients with dry eyes, the tear film is unstable, and breaks up faster. Therefore the tear break up time in patients who have dry eyes is shorter.
In this study, the investigators will be comparing the two previously mentioned FDA-approved eye drops Latanoprost and Travoprost. The difference between the two medications is a preservative called benzalkonium chloride (BAK). Latanoprost contains BAK while Travoprost does not. The investigators will be comparing the efficacy of each medication in lowering IOP as well as trying to track the density of immune cells across the corneal surface by taking photos of your eye. The investigators will also be assessing whether either drop leads to symptoms of dry eye by comparing results from ocular surface exam tests such as TBUT.
Detailed description
The purpose of the study is to compare the early effects of two anti-glaucoma eye drops on eye pressure and inflammation of the eye using a microscope. One of the eye drops contains a commonly used preservative, benzalkonium chloride (BAK), while the other is free of this preservative, instead it utilises a new ionic buffer system called SofZia. Prolonged use of BAK may be damaging to the eye surface and thus being investigated at a microscopic level in this study.
Specific aims are to assess the in vivo effect of topical BAK-containing and BAK-free prostaglandin analogue anti-glaucoma therapy on intraocular pressure (IOP), as well as on density and morphology of corneal immune cells, epithelial cells and sub-basal nerve plexus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Latanoprost (Xalatan) | Active comparator | Drug: Latanoprost7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma. |
| Travoprost (Travatan Z) | Active comparator | Drug: Travoprost7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must be 18 years of age and may be of any race and either gender;
- Subjects must not have ever used topical prostaglandin anti-glaucomatous therapy;
- The IRB Approved informed consent and the privacy document must be read, signed, and dated by the subject or legally authorized representative before enrollment. Additionally, the informed consent document must be signed and dated by the individual consenting the subject, as well as signed and dated by a witness, if applicable;
- Subjects must be generally healthy and have normal ocular health; and
- Subjects must be willing to follow the study procedures and visit schedule.
Key exclusion criteria (14 listed)
- Subjects must not have known sensitivities to any ingredient in any of the test articles
- Subjects must not have any systemic or ocular disease or disorder (exc refractive error), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study:
- Pregnant woman
- Subjects must not have history of ocular surgery/trauma within the last 6 months
- Subjects must not have used any topical ocular or systemic antibiotics within 30 days of enrollment continuing throughout the study
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 |
|---|---|---|
| TravoprostAlso: Travatan ZOne drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily. | Drug | Travoprost (Travatan Z) |
| LatanoprostAlso: XalatanOne drop Xalatan (0.005% ophthalmic solution) in affected eye once daily. | Drug | Latanoprost (Xalatan) |
Primary outcome
Effectiveness in Lowering Intraocular Pressure
Time frame: At the 6 month follow-up time point
Applanation tonometry will be used to measure patients' intraocular pressure
2 secondary outcomes
Corneal Fluorescein Staining Score
Time frame: At the 6 month follow-up time point
Tear Film Break-Up Time
Time frame: At the 6 month follow-up time point
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Pedram Hamrah, MD principal investigator
Mass Eye and Ear Infirmary
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 Travoprost and Latanoprost in people with Glaucoma, run by Massachusetts Eye and Ear Infirmary 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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 16 Mar 2017. 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 3 Feb 2017). 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?
Effectiveness in Lowering Intraocular Pressure (time frame: At the 6 month follow-up time point). 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 16 Mar 2017.