Effects of Anti-Glaucoma Medications on the Ocular Surface

NCT01315574 | Terminated Phase 4 Results

• 1 other identifier: 11-007H
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Effectiveness in Lowering Intraocular Pressure

  Applanation tonometry will be used to measure patients' intraocular pressure

  At the 6 month follow-up time point

Secondary Outcomes (2)

• Corneal Fluorescein Staining Score

  At the 6 month follow-up time point

• Tear Film Break-Up Time

  At the 6 month follow-up time point

Study Arms (2)

Latanoprost (Xalatan)

ACTIVE COMPARATOR

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

Drug: Latanoprost

Travoprost (Travatan Z)

ACTIVE COMPARATOR

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

Drug: Travoprost

Interventions

Travoprost DRUG

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

Also known as: Travatan Z

Travoprost (Travatan Z)

Latanoprost DRUG

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

Also known as: Xalatan

Latanoprost (Xalatan)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• Alcon Research: collaborator

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Glaucoma; Dry Eye Syndromes

Interventions

Travoprost; Latanoprost

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Limitations and Caveats

Early termination due to very slow rate of recruitment, hence reduced power of the study (small sample size); some patients lost to follow-up.

Results Point of Contact

• Title: Dr. Pedram Hamrah
• Organization: Massachusetts Eye and Ear Infirmary

ophthalmologyclinicalresearch@meei.harvard.edu

617-573-6060

Study Officials

• Pedram Hamrah, MD

  Mass Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 15, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 16, 2017
• Results First Posted: February 3, 2017

Record last verified: 2015-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)