Effects of Anti-Glaucoma Medications on the Ocular Surface (BAK)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Massachusetts Eye and Ear Infirmary
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01315574
First received: March 10, 2011
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Glaucoma
Drug: Travoprost
Drug: Latanoprost

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • Effectiveness in Lowering Intraocular Pressure [ Time Frame: 6 months of follow-up ] [ Designated as safety issue: No ]
    Applanation tonometry will be used to measure patients' intraocular pressure


Secondary Outcome Measures:
  • Observation of Dry Eye Symptoms Across the Cornea [ Time Frame: 6 months of follow-up ] [ Designated as safety issue: Yes ]
    Schirmer's Test, Corneal Staining, Conjunctival Staining, and Tear Film Break-Up Time (TBUT) will be used to quantify changes in dry eye symptoms


Estimated Enrollment: 40
Study Start Date: February 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Latanoprost (Xalatan)
20 Patients will be randomized to receive BAK-containing Xalatan for treatment of their glaucoma.
Drug: Latanoprost
One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.
Other Name: Xalatan
Active Comparator: Travoprost (Travatan Z)
20 Patients will be randomized to receive BAK-free Travatan Z for treatment of their glaucoma.
Drug: Travoprost
One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.
Other Name: Travatan Z

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be 18 years of age and may be of any race and either gender;
  • Subjects must not have ever used topical 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.

Exclusion Criteria:

  • 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 (except 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).
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315574

Contacts
Contact: Cornea Research 617-573-3313 Cornea_Research@meei.harvard.edu
Contact: Nicholas Simms 617-573-3173 Nicholas_Simms@meei.harvard.edu

Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Cornea Research    617-573-3313    cornea_research@meei.harvard.edu   
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Alcon Research
Investigators
Principal Investigator: Pedram Hamrah, MD Mass Eye and Ear Infirmary
  More Information

No publications provided

Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01315574     History of Changes
Other Study ID Numbers: 11-007H
Study First Received: March 10, 2011
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts Eye and Ear Infirmary:
Glaucoma
Xalatan
Travatan Z
Latanoprost
Travoprost
Dry Eye

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Latanoprost
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014