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

This study has been terminated.
(Slow Enrollment)
Alcon Research
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary Identifier:
First received: March 10, 2011
Last updated: February 7, 2017
Last verified: January 2015

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 Phase
Drug: Travoprost
Drug: Latanoprost
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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: At the 6 month follow-up time point ]
    Applanation tonometry will be used to measure patients' intraocular pressure

Secondary Outcome Measures:
  • Corneal Fluorescein Staining Score [ Time Frame: At the 6 month follow-up time point ]
    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.

  • Tear Film Break-Up Time [ Time Frame: At the 6 month follow-up time point ]
    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.

Enrollment: 14
Study Start Date: February 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Latanoprost (Xalatan)
7 Patients were 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)
7 Patients were 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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.

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 (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).
  • 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 identifier: NCT01315574

United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Alcon Research
Principal Investigator: Pedram Hamrah, MD Mass Eye and Ear Infirmary
  More Information

Responsible Party: Massachusetts Eye and Ear Infirmary Identifier: NCT01315574     History of Changes
Other Study ID Numbers: 11-007H
Study First Received: March 10, 2011
Results First Received: August 15, 2016
Last Updated: February 7, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Massachusetts Eye and Ear Infirmary:
Travatan Z
Dry Eye

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Antihypertensive Agents
Pharmaceutical Solutions processed this record on May 25, 2017