Keratoconjunctivitis SiccaNCT01213342
Omega-3 Fatty Acid Supplements and Dry Eye
A study testing Omega-3 Fatty Acid and Soybean Soft Gels in people with Keratoconjunctivitis Sicca, run by Ohio State University at 1 site in United States.
Trial summary
Omega-3 fatty acids have been associated with a decline in inflammation. As dry eye disease is associated with inflammation of the ocular surface (DEWS report, Ocular Surface, 2007), the investigators hypothesize that the omega-3 fatty acid supplements used in this study will help to improve dry eye signs, such as eye… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconjunctivitis Sicca
- What is being tested?
- Omega-3 Fatty Acid and Soybean Soft Gels
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each qualified participant will have an eye doctor's diagnosis of dry eye disease.
- Answers to both questions: "How often do your eyes feel dry, how often do your eyes feel irritated" will either be "Often or Constant." (Schaumberg)
- ≥ 18 years of age
- The current use of artificial tears at least one time per week.
- Be willing/able to return for all study visits and to follow instructions from the study investigator and his/her staff.
- Stable dosage for one month time of all ocular medications and systemic medications (includes Restasis).
- Be able to swallow large, soft gels.
Who cannot join
- Patients who are allergic to ingredients of the treatment or placebo soft gels (fish, soybean oil, citrus).
- Current diagnosis of ocular infection (e.g. bacterial, viral or fungal).
- History of ocular herpetic keratitis.
- Past or current history of liver disease.
- Current use of blood thinners.
- Eye surgery (including cataract surgery) within 6 months prior to randomization.
Show all 19Show fewer
- Previous LASIK surgery.
- Pregnant or nursing/lactating.
- Participation in a study of an investigational drug or device within the past 30 days.
- Cognitive or psychiatric deficit that precludes informed consent or ability to perform requirements of the investigation.
- Changes in ocular or systemic medications in the past 30 days.
- Contact lens wearers.
- Glaucoma diagnosis and/or use of glaucoma medications.
- Current use of punctual plugs.
- Current use of EPA/DHA supplements in excess of 1 gram/day.
- Use of ocular steroids currently or in the past 7 days.
- Patients planning on changing dosage of eye medications during the study.
- Patients who have an allergy to fluorescein.
- Patients who take aspirin daily.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Optometry
Columbus, Ohio, 43210
About this study
Official title: Omega-3 Fatty Acid Supplementation and Dry Eye
Omega-3 fatty acids have been associated with a decline in inflammation. As dry eye disease is associated with inflammation of the ocular surface (DEWS report, Ocular Surface, 2007), the investigators hypothesize that the omega-3 fatty acid supplements used in this study will help to improve dry eye signs, such as eye surface irritation (staining) and tear film osmolarity, which is an overall measure of tear film stability and dry eye status. Further, the investigators hypothesize that dry eye symptoms, the end result of dry eye disease, such as discomfort and burning, will also improve with supplementation.
Read the detailed description
Dry Eye is a disorder of the tear film due to tear deficiency or excessive tear evaporation which causes damage to the exposed ocular surface and is associated with symptoms of ocular discomfort. If left untreated, severe dry eyes can lead to desiccation of the corneal epithelium, increased discomfort and sometimes loss of vision. Abundant evidence from animal models and clinical evaluations confirm that inflammation is an integral part of all moderate and severe Dry Eye Disease (DED) states and is likely to be significant in the pathogenesis leading to the chronicity of DED. Omega-3 essential fatty acids (EFAs) have been shown to have anti-inflammatory effects and inhibit multiple aspects of inflammatory response.
DED is a common and growing problem as our population ages, causing chronic pain and visual disturbance that is not adequately treated with current approaches. If left untreated, severe dry eyes can lead to desiccation of the corneal epithelium, increased discomfort and sometimes loss of vision.The benefits are the possibility of alleviating or eliminating these symptoms of DED and the clinical data that will be gained on the safety and efficacy of omega-3s, which are already being marketed over-the-counter for the treatment of DED without any hard scientific data. The potential benefits of treatment outweigh the minimal risk of participation.
This study hopes to discover more about the efficacy and tolerability of omega-3 EFA's in the treatment of dry eye and ocular surface disease.
- Conditions
- Keratoconjunctivitis Sicca
- Being tested
- Omega-3 Fatty Acid, Soybean Soft Gels
- Keywords
- dry eye disease
- 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.
Omega-3 Fatty AcidDietary supplement
Also called Fish Oil Soft Gels, ProOmega
Each patient will be instructed to take 4 soft gel capsules per day (2 with the morning meal and 2 with the evening meal). They will continue this regimen for 8 weeks. The total daily amount included in 4 soft gels includes:
- EPA (Eicosapentaenoic Acid) 1300mg
- DHA (Docosahexaenoic Acid) 900 mg
- Other Omega-3's 360mg
- Total Omega 3's 2560 mg
Soybean Soft GelsDietary supplement
Also called Placebo Soft Gels
Each patient will be instructed to take 4 soft gel capsules per day (2 with the morning meal and 2 with the evening meal. The main ingredient in the placebos is soybean oil (95.6%).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | This group will receive Omega-3 EFA supplements for 8 weeks. They will take 4 capsules/day. Receives: Dietary Supplement: Omega-3 Fatty Acid |
| Placebo Group | Placebo comparator | This group will receive placebo supplements for 8 weeks. They will take 4 capsules a day. Receives: Dietary Supplement: Soybean Soft Gels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ocular Surface Disease Index (OSDI)
Based on previous unpublished work by our group (and others), it is suggestive that a 10 unit change in OSDI score may be clinically meaningful. There currently is no accepted survey instrument to monitor change in DED clinical trials, although the OSDI has wide acceptance clinically. This study will help define what unit of change may be clinically and statistically acceptable for future trials.
Measured: Baseline, 4 weeks into treatment, 8 weeks into treatment
Secondary outcomes (3)
Changes in Osmolarity (TearLab) value
The TearLab also has limited use in DED clinical trials. Our best estimate of a clinically meaningful change is 7 mOsm/kg (reported dry eye, 315mOsm/kg - reported normal, 308 mOsm/kg). Again, as this has never been assessed, these results here are pilot in nature.
Measured: Baseline, 4 weeks, 12 weeks
Changes in Staining scores
Changes in average staining scores (average of 5 corneal regions; 6 conjunctival regions) and sum staining scores will be evaluated.
Measured: Baseline, 4 weeks, 8 weeks
Changes in Tear proteomics
This portion of the study is exploratory in nature. iTRAQ proteomics using mass spectrometry and RayBiotech quantibody microarrays will be used evaluate changes in inflammatory mediators for future biomarker search and pathway analysis.
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Researchers left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Keratoconjunctivitis SiccaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Nordic Naturals
- Investigators
- Kelly K Nichols, OD, MPH, PhD, Principal investigator, The Ohio State University College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213342
- Sponsor's protocol ID
- 2010H0014
- Status last verified
- Mar 2012
- First submitted
- 30 Sep 2010
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Barabino S, Rolando M, Camicione P, Ravera G, Zanardi S, Giuffrida S, Calabria G. Systemic linoleic and gamma-linolenic acid therapy in dry eye syndrome with an inflammatory component. Cornea. 2003 Mar;22(2):97-101. doi: 10.1097/00003226-200303000-00002.
PubMed 12605039Macri A, Giuffrida S, Amico V, Iester M, Traverso CE. Effect of linoleic acid and gamma-linolenic acid on tear production, tear clearance and on the ocular surface after photorefractive keratectomy. Graefes Arch Clin Exp Ophthalmol. 2003 Jul;241(7):561-566. doi: 10.1007/s00417-003-0685-x. Epub 2003 May 27.
PubMed 12768289Roncone M, Bartlett H, Eperjesi F. Essential fatty acids for dry eye: A review. Cont Lens Anterior Eye. 2010 Apr;33(2):49-54; quiz 100. doi: 10.1016/j.clae.2009.11.002. Epub 2009 Dec 23.
PubMed 20031476Massi D, Franchi A, Alos L, Cook M, Di Palma S, Enguita AB, Ferrara G, Kazakov DV, Mentzel T, Michal M, Panelos J, Rodriguez-Peralto JL, Santucci M, Tragni G, Zioga A, Dei Tos AP. Primary cutaneous leiomyosarcoma: clinicopathological analysis of 36 cases. Histopathology. 2010 Jan;56(2):251-62. doi: 10.1111/j.1365-2559.2009.03471.x.
PubMed 20102404Miljanovic B, Trivedi KA, Dana MR, Gilbard JP, Buring JE, Schaumberg DA. Relation between dietary n-3 and n-6 fatty acids and clinically diagnosed dry eye syndrome in women. Am J Clin Nutr. 2005 Oct;82(4):887-93. doi: 10.1093/ajcn/82.4.887.
PubMed 16210721
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acid Supplementation and Dry Eye
- ClinicalTrials.gov ID
- NCT01213342
- Acronym / sponsor ID
- 2010H0014
- Conditions
- Keratoconjunctivitis Sicca
- Keywords
- dry eye disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Researchers left institution
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Nordic Naturals
- Study start
- May 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Oct 2010 (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.
Omega-3 fatty acids have been associated with a decline in inflammation. As dry eye disease is associated with inflammation of the ocular surface (DEWS report, Ocular Surface, 2007), the investigators hypothesize that the omega-3 fatty acid supplements used in this study will help to improve dry eye signs, such as eye surface irritation (staining) and tear film osmolarity, which is an overall measure of tear film stability and dry eye status. Further, the investigators hypothesize that dry eye symptoms, the end result of dry eye disease, such as discomfort and burning, will also improve with supplementation.
Detailed description
Dry Eye is a disorder of the tear film due to tear deficiency or excessive tear evaporation which causes damage to the exposed ocular surface and is associated with symptoms of ocular discomfort. If left untreated, severe dry eyes can lead to desiccation of the corneal epithelium, increased discomfort and sometimes loss of vision. Abundant evidence from animal models and clinical evaluations confirm that inflammation is an integral part of all moderate and severe Dry Eye Disease (DED) states and is likely to be significant in the pathogenesis leading to the chronicity of DED. Omega-3 essential fatty acids (EFAs) have been shown to have anti-inflammatory effects and inhibit multiple aspects of inflammatory response.
DED is a common and growing problem as our population ages, causing chronic pain and visual disturbance that is not adequately treated with current approaches. If left untreated, severe dry eyes can lead to desiccation of the corneal epithelium, increased discomfort and sometimes loss of vision.The benefits are the possibility of alleviating or eliminating these symptoms of DED and the clinical data that will be gained on the safety and efficacy of omega-3s, which are already being marketed over-the-counter for the treatment of DED without any hard scientific data. The potential benefits of treatment outweigh the minimal risk of participation.
This study hopes to discover more about the efficacy and tolerability of omega-3 EFA's in the treatment of dry eye and ocular surface disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Dietary Supplement: Omega-3 Fatty AcidThis group will receive Omega-3 EFA supplements for 8 weeks. They will take 4 capsules/day. |
| Placebo Group | Placebo comparator | Dietary Supplement: Soybean Soft GelsThis group will receive placebo supplements for 8 weeks. They will take 4 capsules a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Each qualified participant will have an eye doctor's diagnosis of dry eye disease.
- Answers to both questions: "How often do your eyes feel dry, how often do your eyes feel irritated" will either be "Often or Constant." (Schaumberg)
- ≥ 18 years of age
- The current use of artificial tears at least one time per week.
- Be willing/able to return for all study visits and to follow instructions from the study investigator and his/her staff.
Key exclusion criteria (19 listed)
- Patients who are allergic to ingredients of the treatment or placebo soft gels (fish, soybean oil, citrus).
- Current diagnosis of ocular infection (e.g. bacterial, viral or fungal).
- History of ocular herpetic keratitis.
- Past or current history of liver disease.
- Current use of blood thinners.
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 AcidAlso: Fish Oil Soft Gels, ProOmegaEach patient will be instructed to take 4 soft gel capsules per day (2 with the morning meal and 2 with the evening meal). They will continue this regimen for 8 weeks. The total daily amount included in 4 soft gels includes: * EPA (Eicosapentaenoic Acid) 1300mg * DHA (Docosahexaenoic Acid) 900 mg * Other Omega-3's 360mg * Total Omega 3's 2560 mg | Dietary supplement | Treatment Group |
| Soybean Soft GelsAlso: Placebo Soft GelsEach patient will be instructed to take 4 soft gel capsules per day (2 with the morning meal and 2 with the evening meal. The main ingredient in the placebos is soybean oil (95.6%). | Dietary supplement | Placebo Group |
Primary outcome
Change in Ocular Surface Disease Index (OSDI)
Time frame: Baseline, 4 weeks into treatment, 8 weeks into treatment
Based on previous unpublished work by our group (and others), it is suggestive that a 10 unit change in OSDI score may be clinically meaningful. There currently is no accepted survey instrument to monitor change in DED clinical trials, although the OSDI has wide acceptance clinically. This study will help define what unit of change may be clinically and statistically acceptable for future trials.
3 secondary outcomes
Changes in Osmolarity (TearLab) value
Time frame: Baseline, 4 weeks, 12 weeks
Changes in Staining scores
Time frame: Baseline, 4 weeks, 8 weeks
Changes in Tear proteomics
Time frame: Baseline, 4 weeks, 8 weeks
Results and safety
The study was stopped early (reason given: Researchers left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
- Background: PubMed 12605039Barabino S, Rolando M, Camicione P, Ravera G, Zanardi S, Giuffrida S, Calabria G. Systemic linoleic and gamma-linolenic acid therapy in dry eye syndrome with an inflammatory component. Cornea. 2003 Mar;22(2):97-101. doi: 10.1097/00003226-200303000-00002.
- Background: PubMed 12768289Macri A, Giuffrida S, Amico V, Iester M, Traverso CE. Effect of linoleic acid and gamma-linolenic acid on tear production, tear clearance and on the ocular surface after photorefractive keratectomy. Graefes Arch Clin Exp Ophthalmol. 2003 Jul;241(7):561-566. doi: 10.1007/s00417-003-0685-x. Epub 2003 May 27.
- Background: PubMed 20031476Roncone M, Bartlett H, Eperjesi F. Essential fatty acids for dry eye: A review. Cont Lens Anterior Eye. 2010 Apr;33(2):49-54; quiz 100. doi: 10.1016/j.clae.2009.11.002. Epub 2009 Dec 23.
- Background: PubMed 20102404Massi D, Franchi A, Alos L, Cook M, Di Palma S, Enguita AB, Ferrara G, Kazakov DV, Mentzel T, Michal M, Panelos J, Rodriguez-Peralto JL, Santucci M, Tragni G, Zioga A, Dei Tos AP. Primary cutaneous leiomyosarcoma: clinicopathological analysis of 36 cases. Histopathology. 2010 Jan;56(2):251-62. doi: 10.1111/j.1365-2559.2009.03471.x.
- Background: PubMed 16210721Miljanovic B, Trivedi KA, Dana MR, Gilbard JP, Buring JE, Schaumberg DA. Relation between dietary n-3 and n-6 fatty acids and clinically diagnosed dry eye syndrome in women. Am J Clin Nutr. 2005 Oct;82(4):887-93. doi: 10.1093/ajcn/82.4.887.
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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.
Kelly K Nichols, OD, MPH, PhD principal investigator
The Ohio State University College of Optometry
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 and Soybean Soft Gels in people with Keratoconjunctivitis Sicca, run by Ohio State University 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 7 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: stopped early, as of the sponsor's last update on 20 Mar 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.
Are results available for this study?
The study was stopped early (reason given: Researchers left institution). Results are not available in the source record.
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 in Ocular Surface Disease Index (OSDI) (time frame: Baseline, 4 weeks into treatment, 8 weeks into treatment). 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 NCT01213342, which also lists 5 linked publications.
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 Mar 2012.