Effects of Anti-Glaucoma Medications on the Ocular Surface
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Travoprost; Latanoprost
Intervention description: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.; One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.
Intervention MeSH terms: Travoprost; Latanoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma; Xalatan; Travatan Z; Latanoprost; Travoprost; Dry Eye

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.
    

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