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Dry Eye Assessment and Management: Feasibility Study (DREAM)

Primary Purpose

Dry Eye Syndromes, Keratoconjunctivitis Sicca

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Omega-3 EFA Supplement

Olive Oil

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Dry Eye Disease, DED, Keratoconjunctivitis Sicca, Omega-3

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).
1. Conjunctival staining present ≥ 1
2. Corneal fluorescein staining present ≥ 1
3. Tear film break up time (TFBUT) ≤ 7 seconds
4. 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

Exclusion Criteria:

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
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.

Sites / Locations

Mount Sinai School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Omega-3 EFA Supplement

Olive Oil

Arm Description

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

Gel Capsule

Outcomes

Primary Outcome Measures

Change on Ocular Surface Disease Index (OSDI)

Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content

Secondary Outcome Measures

Change on Brief Ocular Discomfort Inventory (BODI)

Change on Impact of Dry Eye on Everyday Life (IDEEL)

Change in Quality of Life Associated With Chronic Pain

Change in the Ocular Surface

Change in Schirmer's

Change in Relevant Biomarkers: HLA-DR, MUC 5A, Cytokines

Full Information

NCT ID

NCT01102257

First Posted

April 9, 2010

Last Updated

July 20, 2012

Sponsor

Asbell, Penny, M.D.

Collaborators

National Eye Institute (NEI)

1. Study Identification

Unique Protocol Identification Number

NCT01102257

Brief Title

Dry Eye Assessment and Management: Feasibility Study

Acronym

DREAM

Official Title

Clinical Trial of Essential Fatty Acids for Dry Eye Disease: Feasibility Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asbell, Penny, M.D.

Collaborators

National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndromes, Keratoconjunctivitis Sicca

Keywords

Dry Eye Disease, DED, Keratoconjunctivitis Sicca, Omega-3

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Omega-3 EFA Supplement

Arm Type

Experimental

Arm Description

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

Arm Title

Olive Oil

Arm Type

Placebo Comparator

Arm Description

Gel Capsule

Intervention Type

Drug

Intervention Name(s)

Omega-3 EFA Supplement

Other Intervention Name(s)

Fish oil supplements

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Olive Oil

Intervention Description

Placebo group will take 5 capsules a day containing 3.0 grams of olive oil

Primary Outcome Measure Information:

Title

Change on Ocular Surface Disease Index (OSDI)

Time Frame

90 +/- 14 days following initiation of drug regimen

Title

Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content

Time Frame

Baseline and 3 Months

Secondary Outcome Measure Information:

Title

Change on Brief Ocular Discomfort Inventory (BODI)

Time Frame

90 +/- 14 days following initiation of drug regimen

Title

Change on Impact of Dry Eye on Everyday Life (IDEEL)

Time Frame

90 +/- 14 days following initiation of drug regimen

Title

Change in Quality of Life Associated With Chronic Pain

Time Frame

90 +/- 14 days following initiation of drug regimen

Title

Change in the Ocular Surface

Time Frame

90 +/- 14 days following initiation of drug regimen

Title

Change in Schirmer's

Time Frame

90 +/- 14 days following initiation of drug regimen

Title

Change in Relevant Biomarkers: HLA-DR, MUC 5A, Cytokines

Time Frame

90 +/- 14 days following initiation of drug regimen

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Penny Asbell, • MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

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Dry Eye Assessment and Management: Feasibility Study

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