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Keratoconjunctivitis SiccaNCT00883649

Efficacy and Safety Study of Nutritional Supplements for Treatments of Dry Eye

A study testing Hydroeye and Inactive Capsule in people with Keratoconjunctivitis Sicca, run by Virginia Eye Consultants at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older, women only
Conditions the study is for
Keratoconjunctivitis Sicca
What is being tested?
Hydroeye and Inactive Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
2 sitesUnited States
Study dates
Sep 2008to Dec 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Virginia Eye Consultants

    Norfolk, Virginia, 23502

Other trials in United States

About this study

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

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.

Being tested
Hydroeye, Inactive Capsule
Keywords
Keratoconjunctivitis Sicca, Dry Eyes, Post-menopausal
Medical subject headings
Keratoconjunctivitis Sicca, Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HydroeyeDietary supplement

    2 Capsules BID

  • Inactive CapsuleOther

    2 Capsules BID

Study groups in NCT00883649
Study groupRoleWhat they receive
1Placebo comparatorNot described
Receives: Other: Inactive Capsule
2Active comparatorNot described
Receives: Dietary Supplement: Hydroeye

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Schirmer tear test

    Measured: Screening, Week 4, Week 12, Week 24

  2. Ocular Surface Disease Index

    Measured: Screening, Week 4, Week 12, Week 24

  3. Tear Breakup Time

    Measured: Screening, Week 4, Week 12, Week 24

  4. Corneal Staining with Fluorescein

    Measured: Screening, Week 4, Week 12, Week 24

  5. Impression Cytology

    Measured: Screening, Week 12, Week 24

  6. Conjunctival staining with lissamine

    Measured: Screening, Week 4, Week 12, Week 24

Secondary outcomes (5)

  1. Corneal Topography

    Measured: Screening, Week 4, Week 12, Week 24

  2. Meibomian Gland Dysfunction

    Measured: Screening, Week 4, Week 12, Week 24

  3. Facial Expression Subjective Scale

    Measured: Screening, Week 4, Week 12, Week 24

  4. Frequency of Artificial Tear Usage

    Measured: Screening, Week 4, Week 12, Week 24

  5. HLA-DR Staining of Impression Cytology

    Measured: Screening, Week 12, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2009 (estimated)
  2. Study startSep 2008
  3. Primary completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00883649
Sponsor's protocol ID
SBH2005-01
Status last verified
Feb 2012
First submitted
17 Apr 2009
Last updated
20 Feb 2012
Results posted
No

Publications

  • 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.

    PubMed 23884332

Questions about this trial

What is this clinical trial studying?

A study testing Hydroeye and Inactive Capsule in people with Keratoconjunctivitis Sicca, run by Virginia Eye Consultants at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Schirmer tear test (time frame: Screening, Week 4, Week 12, Week 24). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00883649, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2012.

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