Clinical trial NCT00883649: Efficacy and Safety Study of Nutritional Supplements for Treatments of Dry Eye
Official title: A Randomized, Parallel-Group, Placebo-Control, Double-Blind Trial Comparing the Efficacy and Safety of Nutritional Supplementation Containing Omega 3 Fatty Acids and Gamma Linoleic Acid, for Treatment of Keratoconjunctivitis Sicca in Post-Menopausal Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconjunctivitis Sicca
Keywords: Keratoconjunctivitis Sicca
Dry Eyes
Post-menopausal
Lead sponsor: Virginia Eye Consultants
Sponsor class: OTHER
Collaborators: name: ScienceBased Health
name: Baylor College of Medicine
First posted: 2009-04-20
Enrollment: 62
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of a nutritional supplement in post-menopausal women age 40 or older with moderate to severe dry eyes. This study is being conducted to determine if signs and symptoms of dry eye will improve with the use of this nutritional supplement.


Eligibility criteria: 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

Primary outcomes:
measure: Schirmer tear test
timeFrame: Screening, Week 4, Week 12, Week 24
measure: Ocular Surface Disease Index
timeFrame: Screening, Week 4, Week 12, Week 24
measure: Tear Breakup Time
timeFrame: Screening, Week 4, Week 12, Week 24
measure: Corneal Staining with Fluorescein
timeFrame: Screening, Week 4, Week 12, Week 24
measure: Impression Cytology
timeFrame: Screening, Week 12, Week 24
measure: Conjunctival staining with lissamine
timeFrame: Screening, Week 4, Week 12, Week 24
Secondary outcomes:
measure: Corneal Topography
timeFrame: Screening, Week 4, Week 12, Week 24
measure: Meibomian Gland Dysfunction
timeFrame: Screening, Week 4, Week 12, Week 24
measure: Facial Expression Subjective Scale
timeFrame: Screening, Week 4, Week 12, Week 24
measure: Frequency of Artificial Tear Usage
timeFrame: Screening, Week 4, Week 12, Week 24
measure: HLA-DR Staining of Impression Cytology
timeFrame: Screening, Week 12, Week 24
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: Virginia Eye Consultants
name: John D Sheppard, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Stephen C Pflugfelder, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: ScienceBased Health
name: Joe Wakil, M.D.
role: STUDY_CHAIR
affiliation: ScienceBased Health
name: Penelope Edwards, MPH, CNS
role: STUDY_CHAIR
References:
citation: Sheppard JD Jr, Singh R, McClellan AJ, Weikert MP, Scoper SV, Joly TJ, Whitley WO, Kakkar E, Pflugfelder SC. Long-term Supplementation With n-6 and n-3 PUFAs Improves Moderate-to-Severe Keratoconjunctivitis Sicca: A Randomized Double-Blind Clinical Trial. Cornea. 2013 Oct;32(10):1297-304. doi: 10.1097/ICO.0b013e318299549c.