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Dry Eye DiseasePhase 4NCT00799682

Exploratory Study Comparing Signs and Symptoms in Patients With Ocular Hypertension or Glaucoma Using Xalatan R® or Travatan Z®

A Phase 4 study testing Xalatan and Travatan Z in people with Dry Eye Disease, run by Ophthalmic Consultants of Long Island at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if there is a difference in the ocular signs and symptoms of subjects' eyes using Xalatan® 0.005% versus Travatan Z® 0.004% based on the outcome of subject assessment and clinical assessment in patients with Ocular Hypertension or Glaucoma with mild to moderate dry eye at… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dry Eye Disease
What is being tested?
Xalatan and Travatan Z
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
5 sitesUnited States
Study dates
Oct 2008to Feb 2011
Phase
Phase 4
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or Female 18 years of age or older
  • Only patients who satisfy all informed consent requirements may be included in the study
  • Be likely to complete the entire course of study and comply with study drop regimen, guidelines and visits
  • Able to understand drop instructions and instill study drops
  • Patients must be on monotherapy for Ocular Hypertension or Glaucoma and agree to a washout period, as according to Appendix E
  • Patient has Ocular Hypertension, chronic Open-Angle Glaucoma, chronic Angle-Closure Glaucoma with patent iridotomy/iridectomy, Pseudo Exfoliate Glaucoma, or Pigmentary Glaucoma in each eye at screening visit.
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  • Patients using systemic non-glaucoma medications known to lower IOP may be included, if on stable dose >30 days prior to screening visit and agree to maintain the regimen throughout the course of the study.
  • Patients using non-prescription eye drops or prescription topical eye drops for dry eye may be included, if on stable dose 30 days prior to screening visit and agree to maintain the regimen throughout the course of the study.
  • Patients who wear contact lenses with a maintained wearing pattern for the duration of the study
  • Best Corrected LogMar VA of ≤0.70 =(20/100 Snellen equivalent)
  • Hyperemia Grading ≤2
  • IOP ≤ 30 mmHg
  • Shirmers 3mm - 9.75mm
  • Tear break-up time (TBUT) 4 seconds - 9seconds
  • Must meet the Biomicroscopic Criteria for both eyes as defined by the Oxford Grading Scale
  • Generally good and stable overall health

Who cannot join

  • Females of childbearing potential (those who are not surgically sterilized or defined as one-year post-menopausal) are excluded from participation in the study if they meet any one of the following conditions:They are currently pregnant,They have a positive result on the urine pregnancy test at the Screening Visit,They intend to become pregnant during the study period,They are breast-feeding,or They are not using highly effective birth control measures:
  • Hormonal-oral, implanted, transdermal or injected contraceptives;
  • Mechanical-spermicide in conjunction with a barrier such as a condom or diaphragm or IUD Note: All females of childbearing potential must consent to a urine pregnancy test at Screening. Females of childbearing potential are to be instructed to inform the investigator if they become pregnant during the study. Should this occur, the Investigator shall immediately contact the Sponsor. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the patient becomes sexually active during the study, she must agree to use adequate birth control methods as defined above for the remainder of the study.
  • Patients who are currently on an investigational agent or discontinued within 30 days prior to the Screening Visit
  • Uncontrolled systemic disease
  • Patients who have a known medical history of allergy or sensitivity to prostaglandin drugs (topical and/or systemic)
Show all 27Show fewer
  • Patient with any history of refractive surgery
  • History of ocular trauma within the past six months in either eye
  • History of ocular infection or ocular inflammation within the past three months in either eye
  • History of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye based on the assessment of the Investigator
  • History of any severe ocular pathology according to the Oxford Grading Scale
  • greater than Grade 4 dry eye) in either eye
  • Intraocular surgery within the past six months as determined by patient history and/or examination in either eye.
  • Ocular laser surgery or Punctal Cautery within the past three months as determined by patient history and/or examination in either eye
  • Punctal Plugs insertion ≤ 7 days prior to (Visit 1) Screening
  • Any abnormality preventing reliable applanation tonometry of either eye.
  • Contraindication to pupil dilation or patients with cycloplegia
  • Patients with best-corrected visual acuity score worse than 0.70 LogMar (20/100) score in either eye
  • Patients with ≤30 days stable dosing regimen before the Screening Visit of any medications or substances administered by any route and used on a chronic basis
  • History of Stevens-Johnson Syndrome or Ocular Pemphigoid
  • History of liver disease
  • Severe clinical vitamin deficiencies or history of vitamin overdose
  • Highly variable self-administration of over-the-counter vitamin/herbal products
  • Any steroid use within the past 30 days
  • Corneal pathology, which could, and of itself, cause an ocular surface disorder
  • Visual Field loss which in the opinion of the Investigator is functionally significant or evidence of progress visual field loss within the last year prior to the (Visit 2) Baseline/Randomization
  • Patient has a condition or is in a situation which, in the investigator's opinion, may put the subject at a significant risk, may confound study results, or may interfere significantly with the subject's participation in the study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Ophthalmic Consultants of Long Island

    East Meadow, New York, 11554

  • Ophthalmic Consultants of Long Island

    Lynbrook, New York, 11563

  • Ophthalmic Consultants of Long Island

    Rockville Centre, New York, 11570

  • Ophthalmic Consultants of Long Island

    Stony Brook, New York, 11790

  • Ophthalmic Consultants of Long Island

    Valley Stream, New York, 11581

Other trials in United States

About this study

Official title: An 8 Week, Single Masked, Parallel-Group, Exploratory Study Comparing Ocular Surface Signs and Symptoms in Monotherapy Ocular Hypertension or Glaucoma Patients Randomized to Either Xalatan® or Travatan Z®

The purpose of this study is to determine if there is a difference in the ocular signs and symptoms of subjects' eyes using Xalatan® 0.005% versus Travatan Z® 0.004% based on the outcome of subject assessment and clinical assessment in patients with Ocular Hypertension or Glaucoma with mild to moderate dry eye at baseline in accordance with the Oxford Grading Scale.

Conditions
Dry Eye Disease
Being tested
Xalatan, Travatan Z
Keywords
Dry Eye, Monotherapy for Ocular Hypertension, Glaucoma, Ocular Hypertension, Chronic Open-Angle Glaucoma, Chronic Angle-Closure Glaucoma, Iridotomy, Iridectomy, Pseudo Exfoliate, Pigmentary Glaucoma, Systemic Non-Glaucoma Medications, Hyperemia
Medical subject headings
Dry Eye Syndromes, Glaucoma, Ocular Hypertension, Glaucoma, Open-Angle, Hyperemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XalatanDrug

    Also called Topical Prostaglandin, Latanoprost Ophthalmic Solution

    0.005% 1 drop in each eye daily between 7:00 p.m. and 9:00 p.m.

  • Travatan ZDrug

    Also called Topical Prostaglandin, Travaprost Ophthalmic Solution

    0.004%, 1 drop in each eye daily between 7:00 p.m. and 9:00 p.m.

Study groups in NCT00799682
Study groupRoleWhat they receive
Xalatan®Active comparatorNot described
Receives: Drug: Xalatan
Travatan Z®Active comparatorNot described
Receives: Drug: Travatan Z

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OSDI scores (patient's subjective assessment)

    Measured: Eight Weeks

Secondary outcomes (1)

  1. Clinical Biomicroscopic changes as assessed by Masked Investigator

    Measured: Eight Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionJan 2011
  4. Study completionFeb 2011

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00799682
Sponsor's protocol ID
GA6111ZH
Status last verified
Jul 2011
First submitted
26 Nov 2008
Last updated
21 Jul 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Xalatan and Travatan Z in people with Dry Eye Disease, run by Ophthalmic Consultants of Long Island at 5 sites 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 16 inclusion and 27 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 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

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?

OSDI scores (patient's subjective assessment) (time frame: Eight Weeks). 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 NCT00799682.

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 21 Jul 2011.

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