Dry Eye SyndromesPhase 2/3DREAMNCT01102257
Dry Eye Assessment and Management: Feasibility Study
A Phase 2/3 study testing Omega-3 EFA Supplement and Olive Oil in people with Dry Eye Syndromes and Keratoconjunctivitis Sicca, run by Asbell, Penny, M.D. at 1 site in United States.
Trial summary
The purpose of this study is to test a protocol investigating the efficacy of omega-3 fatty acids in treating dry eye disease. The study is termed "feasibility" because its purpose is to demonstrate an ability to execute the proposed protocol with compliance at two sites rather than generate statistically relevant… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- What is being tested?
- Omega-3 EFA Supplement and Olive Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Mar 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign and date the informed consent form approved by the IRB.
- ≥ 18 years of age
- Demonstrate at least 2 of the 4 following signs in the same eye at two consecutive visits (Visit 1: 7 - 21 days prior to randomization, and Visit 2: day of randomization).
- Conjunctival staining present ≥ 1
- Corneal fluorescein staining present ≥ 1
- Tear film break up time (TFBUT) ≤ 7 seconds
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- Schirmer test ≤ 7 mm/5min
- Demonstrate symptoms of dry eye disease (OSDI score of at least 22 at screening visit and at least 15 at randomization visit).
- Use or desire to use artificial tears on average of 2 times per day in the 2 weeks preceding study entry (run in period). No newly diagnosed patients can be enrolled and if a new patient wants to participate, she/he must be put on tears and re-evaluated in 6 months.
- Intraocular pressure (IOP) ≥ 5 mmHg and ≤ 22 mmHg in each eye.
- Women of child-bearing potential must agree to use a reliable method of contraception during study participation, and must demonstrate a negative urine pregnancy test at screening visit.
- Be willing/able to return for all study visits and to follow instructions from the study investigator and his/her staff.
- Be able to swallow large, soft gelcaps
Who cannot join
- Patients who are allergic to ingredients of the active or placebo pills (fish, olive oil).
- Current diagnosis of ocular infection (e.g. bacterial, viral or fungal).
- History of ocular herpetic keratitis.
- Eye surgery (including cataract surgery) within 6 months prior to randomization.
- Previous LASIK surgery
- Pregnant or nursing/lactating
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- Participation in a study of an investigational drug or device within the past 30 days.
- Recent (≤ 3 months) initiation of use of systemic corticosteroids or other immunosuppressive agent and/or is planning to change treatment during study participation
- Cognitive or psychiatric deficit that precludes informed consent or ability to perform requirements of the investigation.
- Contact lens wearers
- Use of glaucoma medication or history of surgery for glaucoma.
- Recent (≤ 3 months) insertion of punctual plugs.
- Using punctual plugs but unwilling to commit to their use for the duration of the study.
- Unwilling to commit to same brand of artificial tears throughout the study.
- Current use of EPA/DHA supplements in excess of 1 gram/day.
- Recent (≤ 6 months) initiation of use of Restasis.
- Use of Restasis but unwilling to commit to use of Restasis for the duration of the study.
- Discontinued use of Restasis within the last 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: Clinical Trial of Essential Fatty Acids for Dry Eye Disease: Feasibility Study
The purpose of this study is to test a protocol investigating the efficacy of omega-3 fatty acids in treating dry eye disease. The study is termed "feasibility" because its purpose is to demonstrate an ability to execute the proposed protocol with compliance at two sites rather than generate statistically relevant data concerning the safety and efficacy of the supplement in patients with dry eye disease.
Read the detailed description
Dry eye disease (DED) is a common but often inadequately treated disease of the tears and surface of the eye. It can cause poor vision and chronic pain and is more frequent with increasing age. Inflammation may be an important component of this disease. This is supported by the observation that cyclosporine, a drug that targets the immune system, is approved for and effectively treats DED. Inflammatory processes likely produce ocular surface damage and contribute to chronic DED. Because not all people with DED respond to current anti-inflammatory treatments, other immune-modulating treatments would be of value. Furthermore, despite a great deal of evidence supporting DED as an inflammatory disease, not all researchers currently agree with this classification. More data that specifically measures inflammatory responses in DED needs to be collected in a well-characterized patient population and correlated with signs and symptoms of DED in order to improve our understanding and classification of the disease.
Essential Fatty Acids (EFA) have been shown to diminish inflammatory responses in many human inflammatory diseases, and interest in the use of omega-3 and omega-6 fatty acids for disease treatment has resulted in several small studies as well as the use (and over-the-counter availability) of EFA-containing nutritional supplements, including several specifically for the treatment of DED. Despite this interest in EFA for DED, there are no strong empirical data from a well-controlled randomized controlled trial RCT supporting the use of EFA for DED. We postulate that DED is an inflammatory disease and hypothesize that EFA can mediate immune responses, thus improving DED signs, symptoms and associated measures of inflammation. The proposed three month feasibility study allows us the chance to demonstrate our ability to successfully execute our own protocol with compliance from the study patients before we begin the process of initiating a full-scale multi-center trial.
- Conditions
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- Being tested
- Omega-3 EFA Supplement, Olive Oil
- Keywords
- Dry Eye Disease, DED, Keratoconjunctivitis Sicca, Omega-3
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 EFA SupplementDrug
Also called Fish oil supplements
The total daily dose from the 5 capsules in treatment group will be 3.0 grams of omega-3 EFAs comprised of:
2000 mg EPA 1000 mg DHA
Olive OilDrug
Placebo group will take 5 capsules a day containing 3.0 grams of olive oil
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 EFA Supplement | Experimental | The total daily dose from the 5 capsules in treatment group will be 3.0 grams of omega-3 esssential fatty acid i.e Omega-3 EFA supplement comprised of:
2000 mg EPA 1000 mg DHA Receives: Drug: Omega-3 EFA Supplement |
| Olive Oil | Placebo comparator | Gel Capsule Receives: Drug: Olive Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on Ocular Surface Disease Index (OSDI)
Measured: 90 +/- 14 days following initiation of drug regimen
Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content
Measured: Baseline and 3 Months
Secondary outcomes (6)
Change on Brief Ocular Discomfort Inventory (BODI)
Measured: 90 +/- 14 days following initiation of drug regimen
Change on Impact of Dry Eye on Everyday Life (IDEEL)
Measured: 90 +/- 14 days following initiation of drug regimen
Change in Quality of Life Associated With Chronic Pain
Measured: 90 +/- 14 days following initiation of drug regimen
Change in the Ocular Surface
Measured: 90 +/- 14 days following initiation of drug regimen
Change in Schirmer's
Measured: 90 +/- 14 days following initiation of drug regimen
Change in Relevant Biomarkers: HLA-DR, MUC 5A, Cytokines
Measured: 90 +/- 14 days following initiation of drug regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asbell, Penny, M.D.
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Penny Asbell, Asbell, Penny, M.D.
- Investigators
- Penny Asbell, • MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102257
- Sponsor's protocol ID
- 05-1099
- Other IDs
- 1R34EY017626
- Acronym
- DREAM
- Status last verified
- Jul 2012
- First submitted
- 9 Apr 2010
- Last updated
- 23 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Essential Fatty Acids for Dry Eye Disease: Feasibility Study
- ClinicalTrials.gov ID
- NCT01102257
- Acronym / sponsor ID
- DREAM / 05-1099
- Conditions
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
- Keywords
- Dry Eye Disease, DED, Keratoconjunctivitis Sicca, Omega-3
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Asbell, Penny, M.D.
- Collaborators
- National Eye Institute (NEI)
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Posted 23 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test a protocol investigating the efficacy of omega-3 fatty acids in treating dry eye disease. The study is termed "feasibility" because its purpose is to demonstrate an ability to execute the proposed protocol with compliance at two sites rather than generate statistically relevant data concerning the safety and efficacy of the supplement in patients with dry eye disease.
Detailed description
Dry eye disease (DED) is a common but often inadequately treated disease of the tears and surface of the eye. It can cause poor vision and chronic pain and is more frequent with increasing age. Inflammation may be an important component of this disease. This is supported by the observation that cyclosporine, a drug that targets the immune system, is approved for and effectively treats DED. Inflammatory processes likely produce ocular surface damage and contribute to chronic DED. Because not all people with DED respond to current anti-inflammatory treatments, other immune-modulating treatments would be of value. Furthermore, despite a great deal of evidence supporting DED as an inflammatory disease, not all researchers currently agree with this classification. More data that specifically measures inflammatory responses in DED needs to be collected in a well-characterized patient population and correlated with signs and symptoms of DED in order to improve our understanding and classification of the disease.
Essential Fatty Acids (EFA) have been shown to diminish inflammatory responses in many human inflammatory diseases, and interest in the use of omega-3 and omega-6 fatty acids for disease treatment has resulted in several small studies as well as the use (and over-the-counter availability) of EFA-containing nutritional supplements, including several specifically for the treatment of DED. Despite this interest in EFA for DED, there are no strong empirical data from a well-controlled randomized controlled trial RCT supporting the use of EFA for DED. We postulate that DED is an inflammatory disease and hypothesize that EFA can mediate immune responses, thus improving DED signs, symptoms and associated measures of inflammation. The proposed three month feasibility study allows us the chance to demonstrate our ability to successfully execute our own protocol with compliance from the study patients before we begin the process of initiating a full-scale multi-center trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 EFA Supplement | Experimental | Drug: Omega-3 EFA SupplementThe total daily dose from the 5 capsules in treatment group will be 3.0 grams of omega-3 esssential fatty acid i.e Omega-3 EFA supplement comprised of: 2000 mg EPA 1000 mg DHA |
| Olive Oil | Placebo comparator | Drug: Olive OilGel Capsule |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Sign and date the informed consent form approved by the IRB.
- ≥ 18 years of age
- Demonstrate at least 2 of the 4 following signs in the same eye at two consecutive visits (Visit 1: 7 - 21 days prior to randomization, and Visit 2: day of randomization).
- Demonstrate symptoms of dry eye disease (OSDI score of at least 22 at screening visit and at least 15 at randomization visit).
- Use or desire to use artificial tears on average of 2 times per day in the 2 weeks preceding study entry (run in period). No newly diagnosed patients can be enrolled and if a new patient wants to participate, she/he must be put on tears and re-evaluated in 6 months.
Key exclusion criteria (18 listed)
- Patients who are allergic to ingredients of the active or placebo pills (fish, olive oil).
- Current diagnosis of ocular infection (e.g. bacterial, viral or fungal).
- History of ocular herpetic keratitis.
- Eye surgery (including cataract surgery) within 6 months prior to randomization.
- Previous LASIK surgery
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 EFA SupplementAlso: Fish oil supplementsThe total daily dose from the 5 capsules in treatment group will be 3.0 grams of omega-3 EFAs comprised of: 2000 mg EPA 1000 mg DHA | Drug | Omega-3 EFA Supplement |
| Olive OilPlacebo group will take 5 capsules a day containing 3.0 grams of olive oil | Drug | Olive Oil |
Primary outcome
Change on Ocular Surface Disease Index (OSDI)
Time frame: 90 +/- 14 days following initiation of drug regimen
Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content
Time frame: Baseline and 3 Months
6 secondary outcomes
Change on Brief Ocular Discomfort Inventory (BODI)
Time frame: 90 +/- 14 days following initiation of drug regimen
Change on Impact of Dry Eye on Everyday Life (IDEEL)
Time frame: 90 +/- 14 days following initiation of drug regimen
Change in Quality of Life Associated With Chronic Pain
Time frame: 90 +/- 14 days following initiation of drug regimen
Change in the Ocular Surface
Time frame: 90 +/- 14 days following initiation of drug regimen
Change in Schirmer's
Time frame: 90 +/- 14 days following initiation of drug regimen
Change in Relevant Biomarkers: HLA-DR, MUC 5A, Cytokines
Time frame: 90 +/- 14 days following initiation of drug regimen
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Penny Asbell, • MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Omega-3 EFA Supplement and Olive Oil in people with Dry Eye Syndromes and Keratoconjunctivitis Sicca, run by Asbell, Penny, M.D. 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?
The sponsor lists 13 inclusion and 18 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 23 Aug 2012. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change on Ocular Surface Disease Index (OSDI) (time frame: 90 +/- 14 days following initiation of drug regimen). The study lists 2 primary outcomes in all. 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 23 Aug 2012.