| Criteria: |
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Inclusion Criteria:
- Signature on the written informed consent form
- Patient motivation and willingness to cooperate with the investigator by following
the required medication regimen
- Patient willingness and ability to return for all visits during the study
- Rapid tear film break up time of eight seconds or less in at least one eye AND/OR
- Signs of meibomian gland dysfunction (MGD) including at least grade one lid
notching, or the presence of orifice pustules
- At least grade one fluorescein superficial punctate keratitis (SPK) in at least one
corneal quadrant or at least grade one conjunctival lissamine green staining in at
least one eye.
- Ocular Surface Disease Index score of sixteen or greater.
- Willing to discontinue use of any current dry eye treatment (except artificial tears)
for four weeks prior to randomization, and during the course of the six month study
- Post-menopausal women aged 40 years old or above. Post menopause is defined as
absence of menstrual period for at least one year, or surgical hysterectomy with
bilateral oophorectomy no less than six months prior
- If using transdermal, vaginal or systemic estrogen, progesterone, or estrogen
derivatives, must be on a stable dose for at least 90 days, and be planning on
staying on same stable dose for duration of the study
Exclusion Criteria:
- Concurrent involvement in any other clinical trial involving an investigational drug
or device
- Compromised cognitive ability which may be expected to interfere with study
compliance
- Uncontrolled or poorly controlled systemic disease (e.g., hypertension, diabetes) or
the presence of any significant illness (e.g., serious gastrointestinal, renal,
hepatic, endocrine, pulmonary, cardiac, neurological disease, cancer, AIDS, or
cerebral dysfunction) that could, in the judgment of the investigator, jeopardize
subject safety or interfere with the interpretation of the results of the study
- Known hypersensitivity to any components of the study or procedural medication
- Anticipated contact lens wear during the study
- History of corneal transplant
- Active ocular infection, uveitis or non-KCS inflammation
- History of recurrent herpes keratitis or active disease within the last six months
- History of cataract surgery within 3 months prior to enrollment
- History of ocular surface surgery (i.e. refractive, lasik, pterygium) within 6 months
prior to enrollment
- corneal disorder or abnormality that affects corneal sensitivity or normal spreading
of the tear film [except superficial punctate keratitis (SPK)]
- Use of systemic cyclosporine within prior 3 months
- Initiation, discontinuation or change in dosage of antihistamines, cholinergic
agents, beta-blocking agents, tricyclic or SSRI antidepressants, phenothiazines, or
topical or systemic acne rosacea medications in two months prior to enrollment, or
anticipated change in dosage during course of study
- Topical ophthalmic medications within prior 4 weeks, or anticipated use of same
during the study (except artificial tears)
- Use of Coumadin or Plavix within prior 2 weeks, or anticipated use of same during
study. Stable dosing of aspirin 325mg or 85 mg per day is permitted.
- Use of fish oil, borage, evening primrose, flaxseed or black current seed oil
supplements in the past three months
- Routine, usual dietary intake of more than 12 ounces of cold water fatty fish (tuna,
salmon, mackerel, sea bass, sardines or herring) per week
- Occlusion of the lacrimal puncta either surgically or with temporary collagen punctal
plugs within one month prior to study, or anticipated use of same during study
- A patient condition or situation which, in the judgment of the investigator, may put
the patient at a significant risk, may confound the study results, or may interfere
with the patient's participation in the study |