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

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.

Study Overview

• Status: Terminated
• Conditions: Glaucoma
• Intervention / Treatment: Drug: Latanoprost; Drug: Travoprost

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts Eye and Ear Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Travatan Z

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness in Lowering Intraocular Pressure	Applanation tonometry will be used to measure patients' intraocular pressure	At the 6 month follow-up time point

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At the 6 month follow-up time point

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Pedram Hamrah, MD, Mass Eye and Ear Infirmary

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: March 10, 2011
• First Submitted That Met QC Criteria: March 14, 2011
• First Posted (Estimate): March 15, 2011

Study Record Updates

• Last Update Posted (Actual): March 16, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Glaucoma; Dry Eye; Xalatan; Latanoprost; Travoprost; Travatan Z
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Antihypertensive Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Travoprost; Latanoprost
• Other Study ID Numbers: 11-007H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No