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

Primary Purpose

Glaucoma

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Travoprost

Latanoprost

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Xalatan, Travatan Z, Latanoprost, Travoprost, Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts Eye and Ear Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Latanoprost (Xalatan)

Travoprost (Travatan Z)

Arm Description

7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.

7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.

Outcomes

Primary Outcome Measures

Effectiveness in Lowering Intraocular Pressure

Applanation tonometry will be used to measure patients' intraocular pressure

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT01315574

First Posted

March 10, 2011

Last Updated

February 7, 2017

Sponsor

Massachusetts Eye and Ear Infirmary

Collaborators

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT01315574

Brief Title

Effects of Anti-Glaucoma Medications on the Ocular Surface

Acronym

BAK

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Terminated

Why Stopped

Slow Enrollment

Study Start Date

February 2011 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Massachusetts Eye and Ear Infirmary

Collaborators

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

Glaucoma, Xalatan, Travatan Z, Latanoprost, Travoprost, Dry Eye

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Latanoprost (Xalatan)

Arm Type

Active Comparator

Arm Description

7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.

Arm Title

Travoprost (Travatan Z)

Arm Type

Active Comparator

Arm Description

7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.

Intervention Type

Drug

Intervention Name(s)

Travoprost

Other Intervention Name(s)

Travatan Z

Intervention Description

One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.

Intervention Type

Drug

Intervention Name(s)

Latanoprost

Other Intervention Name(s)

Xalatan

Intervention Description

One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.

Primary Outcome Measure Information:

Title

Effectiveness in Lowering Intraocular Pressure

Description

Applanation tonometry will be used to measure patients' intraocular pressure

Time Frame

At the 6 month follow-up time point

Secondary Outcome Measure Information:

Title

Corneal Fluorescein Staining Score

Description

Time Frame

At the 6 month follow-up time point

Title

Tear Film Break-Up Time

Description

Time Frame

At the 6 month follow-up time point

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pedram Hamrah, MD

Organizational Affiliation

Mass Eye and Ear Infirmary

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts Eye and Ear Infirmary

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Effects of Anti-Glaucoma Medications on the Ocular Surface

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