Dry Eye SyndromeNCT00344721
A Placebo Controlled Double Masked Clinical Assessment Study of Essential Fatty Acid Supplement and Its Effect on Patients With Apparent Aqueous Deficient Dry Eye Syndrome
A study testing Omega-3 fatty acid supplement in people with Dry Eye Syndrome, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
To determine the effect of Essential Fatty Acids (EFA's) on Meibomian Gland lipids and aqueous tear production in patients with "dry eyes". Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Omega-3 fatty acid supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Oct 2008
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Patient over 18 years of age, patient willing and able to comply with the protocol, no planned changes in diet, topical or systemic drugs during course of study. Ocular symptoms consistent with dry eye of insidious onset and greater than three months duration. Ocular surface vital staining consistent with aqueous deficient dry eyes with less than +1 conjunctival injection and no more than minimal lid inflammation -
Exclusion Criteria: Any patient that uses topical eye drops other than artificial tears. Any patient with punctual occlusion or punctual plugs. Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, history of retinal detachment, concurrent contact lens use during the trial period, ocular surgery within the past six months, patients with glaucoma, anterior membrane dystrophy, active trichiasis or any eyelid globe malposition abnormality, e.g., entropion, ectropion, etc. Patients with Epiphora (excessive tearing). Moreover, patients taking medications known to effect aqueous tear production or meibomian secretions. Patient must not have participated in (or be currently participating in) any investigational therapeutic drug or device trial within the previous 30 days prior to their start date for this trial. In addition, any patient suffering from organic brain syndromes or major psychiatric disorder that would interfere with compliance or subjective reporting will be discouraged from participating in this trial.
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Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8866
About this study
To determine the effect of Essential Fatty Acids (EFA's) on Meibomian Gland lipids and aqueous tear production in patients with "dry eyes".
Read the detailed description
The effects of essential fatty acids on Meibomian Gland lipid composition and aqueous tear production may be greater than previously thought. Dry Eye syndromes afflict millions of people worldwide, more than 10 million in the United States alone. Typically, symptoms that are associated with dry eye disease include ocular burning, foreign body sensation, photophobia and other symptoms that result in overall chronic discomfort in patients. Unfortunately, the effects of Essential Fatty Acids on aqueous tears or Meibomian lipids (AT) have not been established to date. The purpose of this study is to better understand the role essential fatty acids play in the maintenance of meibomian gland lipids and overall production or retention of aqueous tears.
Patients diagnosed with dry eye syndrome will be selected to participate in the study. Once qualified to take part in the trial, participants randomized to the active comparator arm will receive four oral doses of soft-gel capsules to be taken daily (QD). Omega-3 Fatty Acid daily content:
EPA (eicosapentaenoic acid) Dose: 450mg DHA (docosahexaenoic acid) Dose: 300mg Flaxseed Oil (organic) Dose: 1000mg
Patients on placebo will receive nutritional supplement capsules containing wheat germ oil but no EFA's. During the trial, patient will be encouraged not to change their diet, use of topical ophthalmics and systemic therapies other than the use of study treatment. Patient's topical therapy will be standardized after identification exam so that all patients will use TheraTears™ four times daily. Patients will be directed to take the masked capsules in the following manner: 4 soft-gels in the morning.
Masked medication, TheraTears™ and randomization tables will be provided by sponsor.
Subject will have the following tests performed during the first visit (before initiating treatment) and follow-up (after three months of treatment) visit,: a complete eye exam, (vital staining of ocular surface and tear break-up time); completion of questionnaires: Ocular Surface Index (OSDI) and Patient Symptomology Questionnaire will be presented to the patient to review and answer at both visits: Before initiating treatment and after three months on therapy, meibography, fluorophotometry will be performed in order to measure tear volume, flow and turnover, Schirmer test; and tear evaporation using an evaporimeter; meibomian gland drop out determined by infrared photography and meibomian gland secretion for biochemical analysis.
- Conditions
- Dry Eye Syndrome
- Being tested
- Omega-3 fatty acid supplement, Placebo
- Keywords
- Meibomian Gland Syndrome, Blepharitis
- Medical subject headings
- Dry Eye Syndromes, Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acid supplementDietary supplement
Participants receive four oral doses of soft-gel capsules to be taken daily (QD) for 3 months.
PlaceboDietary supplement
Participants receive four oral doses of soft-gel capsules containing wheat germ oil to be taken daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| EPA/DHA/flaxseed | Active comparator | Study patients in the active comparator arm will take four soft-gel capsules containing omega-3 fatty acids (a nutritional supplement) orally daily for 3 months. Each daily dose contains eicosapentaenoic acid (450 mg), docosahexaenoic acid (300 mg) and flaxseed oil (1000 mg). Receives: Dietary Supplement: Omega-3 fatty acid supplement |
| Wheat germ oil | Placebo comparator | Study patients in the placebo arm will take four doses of soft-gel capsules containing wheat germ oil orally daily for 3 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid biochemistry changes: pre and post treatment
Meibomian gland secretions will be subjected to biochemical analysis.
Measured: 3 months
Secondary outcomes (2)
Evaporometry changes: pre and post treatment
Tear evaporation rate will be measured using an evaporometer.
Measured: 3 months
Fluorophotometry changes:pre and post treatment
Clearance rate of the topically applied dye fluorescein will be measured by fluorophotometry.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startSep 2004
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Patients will be randomized to receive either omega-3 fatty acid or placebo soft-gel capsules.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Vision Research
- Responsible party
- Principal investigator, James McCulley, University of Texas Southwestern Medical Center
- Investigators
- James P. McCulley, M.D., Principal investigator, University of Texas, Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344721
- Sponsor's protocol ID
- 082004-008
- Status last verified
- May 2018
- First submitted
- 23 Jun 2006
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled Double Masked Clinical Assessment Study of Essential Fatty Acid Supplement and Its Effect on Patients With Apparent Aqueous Deficient Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT00344721
- Acronym / sponsor ID
- 082004-008
- Conditions
- Dry Eye Syndrome
- Keywords
- Meibomian Gland Syndrome, Blepharitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Advanced Vision Research
- Study start
- Sep 2004
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 27 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effect of Essential Fatty Acids (EFA's) on Meibomian Gland lipids and aqueous tear production in patients with "dry eyes".
Detailed description
The effects of essential fatty acids on Meibomian Gland lipid composition and aqueous tear production may be greater than previously thought. Dry Eye syndromes afflict millions of people worldwide, more than 10 million in the United States alone. Typically, symptoms that are associated with dry eye disease include ocular burning, foreign body sensation, photophobia and other symptoms that result in overall chronic discomfort in patients. Unfortunately, the effects of Essential Fatty Acids on aqueous tears or Meibomian lipids (AT) have not been established to date. The purpose of this study is to better understand the role essential fatty acids play in the maintenance of meibomian gland lipids and overall production or retention of aqueous tears.
Patients diagnosed with dry eye syndrome will be selected to participate in the study. Once qualified to take part in the trial, participants randomized to the active comparator arm will receive four oral doses of soft-gel capsules to be taken daily (QD). Omega-3 Fatty Acid daily content:
EPA (eicosapentaenoic acid) Dose: 450mg DHA (docosahexaenoic acid) Dose: 300mg Flaxseed Oil (organic) Dose: 1000mg
Patients on placebo will receive nutritional supplement capsules containing wheat germ oil but no EFA's. During the trial, patient will be encouraged not to change their diet, use of topical ophthalmics and systemic therapies other than the use of study treatment. Patient's topical therapy will be standardized after identification exam so that all patients will use TheraTears™ four times daily. Patients will be directed to take the masked capsules in the following manner: 4 soft-gels in the morning.
Masked medication, TheraTears™ and randomization tables will be provided by sponsor.
Subject will have the following tests performed during the first visit (before initiating treatment) and follow-up (after three months of treatment) visit,: a complete eye exam, (vital staining of ocular surface and tear break-up time); completion of questionnaires: Ocular Surface Index (OSDI) and Patient Symptomology Questionnaire will be presented to the patient to review and answer at both visits: Before initiating treatment and after three months on therapy, meibography, fluorophotometry will be performed in order to measure tear volume, flow and turnover, Schirmer test; and tear evaporation using an evaporimeter; meibomian gland drop out determined by infrared photography and meibomian gland secretion for biochemical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized to receive either omega-3 fatty acid or placebo soft-gel capsules.
| Arm | Type | Receives |
|---|---|---|
| EPA/DHA/flaxseed | Active comparator | Dietary Supplement: Omega-3 fatty acid supplementStudy patients in the active comparator arm will take four soft-gel capsules containing omega-3 fatty acids (a nutritional supplement) orally daily for 3 months. Each daily dose contains eicosapentaenoic acid (450 mg), docosahexaenoic acid (300 mg) and flaxseed oil (1000 mg). |
| Wheat germ oil | Placebo comparator | Dietary Supplement: PlaceboStudy patients in the placebo arm will take four doses of soft-gel capsules containing wheat germ oil orally daily for 3 months. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acid supplementParticipants receive four oral doses of soft-gel capsules to be taken daily (QD) for 3 months. | Dietary supplement | EPA/DHA/flaxseed |
| PlaceboParticipants receive four oral doses of soft-gel capsules containing wheat germ oil to be taken daily for 3 months. | Dietary supplement | Wheat germ oil |
Primary outcome
Lipid biochemistry changes: pre and post treatment
Time frame: 3 months
Meibomian gland secretions will be subjected to biochemical analysis.
2 secondary outcomes
Evaporometry changes: pre and post treatment
Time frame: 3 months
Fluorophotometry changes:pre and post treatment
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James P. McCulley, M.D. principal investigator
University of Texas, Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 fatty acid supplement in people with Dry Eye Syndrome, run by University of Texas Southwestern Medical Center at 1 site 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?
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 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Lipid biochemistry changes: pre and post treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2018.