Ocular Surface DiseaseNCT01630551
Omega 3 Supplementation and Ocular Surface Disease in Glaucoma
A study testing Fishoil supplement and Olive Oil in people with Ocular Surface Disease, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Ocular surface disease (OSD) is a significant health problem that affects more than 10 million persons in the United States alone. OSD is highly prevalent among medically treated patients with glaucoma and is associated with the number of intraocular pressure (IOP)-lowering medications used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Surface Disease
- What is being tested?
- Fishoil 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Feb 2017
- 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
- Age > 18 years
- Typical symptoms of dry eye (photophobia, burning, foreign body sensation, blurred vision improved with blinking)
- OSDI score > 12
- Schirmer Test with Anesthesia < 8 mm/5 minutes
- Fluorescein tear break-up time < 8 seconds
- No current use of dry eye treatment (except artificial lubrication)
Who cannot join
- Infectious keratoconjunctivitis or inflammatory disease unrelated to dry eye or topical glaucoma medication use
- Patients with severe tear deficiency (defined as Schirmer tes <5 mm/5 min)
- Concomitant ocular pathology
- History of ocular surgery
- Eyelid or eyelash abnormalities
- Alteration of the nasolacrimal apparatus
Show all 14Show fewer
- Treatment with drugs affecting tearing
- Treatment with vitamin supplements
- Concomitant ocular therapies
- Topical ophthalmic steroids taken during the 4 weeks before the study
- Pregnant/breast-feeding women
- Women who may be pregnant at the baseline visit or may become pregnant during the 90 days of therapy
- Diabetes
- History of fish and/or shellfish allergy or hypersensitivity
Trial locations and contacts
1 site in 1 country.
United States1 site
Glaucoma Service, Department of Ophthalmology and Visual Science
Chicago, Illinois, 60612
About this study
Official title: Omega-3 Fatty Acid Nutritional Supplementation in the Treatment of Ocular Surface Disease Associated With Intraocular Pressure-Lowering Medications
Ocular surface disease (OSD) is a significant health problem that affects more than 10 million persons in the United States alone. OSD is highly prevalent among medically treated patients with glaucoma and is associated with the number of intraocular pressure (IOP)-lowering medications used.
The purpose of this study is to determine the potential effectiveness of anoritega-3 fatty acid nutritional supplement in the treatment of ocular surface disease associated"with the use of glaucoma eye drops
Read the detailed description
Description of procedures/methods:
BASELINE VISIT Once the treating ophthalmologist has made the diagnosis of OSD, subjects will be asked to participate in the research study. Informed consent will be obtained for all subjects willing to participate in the study. Afterwards, the treating ophthalmologist will administer a dry eye questionnaire to each subject. After completion of the questionnaire, subjects will be given 90-day supply of the study drug/placebo. Based on a pre-determined randomization list, each subjects will be randomized to receive either the study medication (TheraTears nutritional supplementation) or a placebo drug (olive oil capsules). All subjects will be instructed to continue using artificial lubrication as needed while taking part in this study.
We hypothesize that therapy with an oral fish oil nutritional supplement containing 450mg EPA, 300 mg DHA, and 1000 mg flaxseed oil (TheraTears Nutrition; Advanced Vision Research, Woburn, MA) will decrease OSD-related symptoms as well as clinical markers associated with OSD (Schirmer test values, positive vital staining with lissamine green, fluorescein tear break-up time, and tear film osmolarity) when compared to administration of placebo.
FOLLOW-UP VISIT Approximately 90 days after the baseline visit, subjects are scheduled to come to the clinic for their routine• eye check. At that visit, subject's O.SD will be re-assessed by the same examination techniques as the baseline visit. After the examination, the questionnaire will be administered for a second time. The study drug will be discontinued at that visit and standard therapy for the subject's OSO, as deemed necessary by the treating ophthalmologist, will be instituted.
Statement of duration of subject participation:
Subject will be in the study for 3 months. There will be two visits, one is the baseline and second is the follow-up visit. All visits will coincide with their regular clinic visit. The total hours of study participation is no more than 2 hours.
- Conditions
- Ocular Surface Disease
- Being tested
- Fishoil supplement, Olive Oil
- Keywords
- tears, dry eyes, ocular surface disease
- Medical subject headings
- Lacerations, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fishoil supplementDietary supplement
1 capsule per day
Olive OilDietary supplement
1 capsule per day
| Study group | Role | What they receive |
|---|---|---|
| Fishoil nutritional supplement | Active comparator | 90 day supply of daily oral administration of a fish oil nutritional supplement (TheraTears Nutrition; Advanced Vision Research, Woburn, MA) Receives: Dietary Supplement: Fishoil supplement |
| Olive oil capsules | Placebo comparator | 90 day supply of a daily dose of placebo olive oil capsules Receives: Dietary Supplement: Olive Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index Score
Ocular surface disease validated questionnaire regarding ocular symptoms
Measured: 90 Days
Secondary outcomes (3)
Schirmer test score
Scoring of tear production over 5 minutes
Measured: 90 days
Lissamine Green Staining Score
Ocular staining pattern for significant ocular surface disease
Measured: 90 Days
Fluorescein tear break-up time
Clinical measure of tear film stability
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface DiseaseStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Omega 3 fatty acid
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- American Glaucoma Society
- Responsible party
- Principal investigator, Ahmad A. Aref, MD, University of Illinois Chicago
- Investigators
- Ahmad A Aref, MD, Principal investigator, University of Illinois at Chicago College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630551
- Sponsor's protocol ID
- 2011-1136
- Status last verified
- Feb 2017
- First submitted
- 31 May 2012
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acid Nutritional Supplementation in the Treatment of Ocular Surface Disease Associated With Intraocular Pressure-Lowering Medications
- ClinicalTrials.gov ID
- NCT01630551
- Acronym / sponsor ID
- 2011-1136
- Conditions
- Ocular Surface Disease
- Keywords
- tears, dry eyes, ocular surface disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- American Glaucoma Society
- Study start
- Apr 2012
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 28 Jun 2012 (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.
Ocular surface disease (OSD) is a significant health problem that affects more than 10 million persons in the United States alone. OSD is highly prevalent among medically treated patients with glaucoma and is associated with the number of intraocular pressure (IOP)-lowering medications used.
The purpose of this study is to determine the potential effectiveness of anoritega-3 fatty acid nutritional supplement in the treatment of ocular surface disease associated"with the use of glaucoma eye drops
Detailed description
Description of procedures/methods:
BASELINE VISIT Once the treating ophthalmologist has made the diagnosis of OSD, subjects will be asked to participate in the research study. Informed consent will be obtained for all subjects willing to participate in the study. Afterwards, the treating ophthalmologist will administer a dry eye questionnaire to each subject. After completion of the questionnaire, subjects will be given 90-day supply of the study drug/placebo. Based on a pre-determined randomization list, each subjects will be randomized to receive either the study medication (TheraTears nutritional supplementation) or a placebo drug (olive oil capsules). All subjects will be instructed to continue using artificial lubrication as needed while taking part in this study.
We hypothesize that therapy with an oral fish oil nutritional supplement containing 450mg EPA, 300 mg DHA, and 1000 mg flaxseed oil (TheraTears Nutrition; Advanced Vision Research, Woburn, MA) will decrease OSD-related symptoms as well as clinical markers associated with OSD (Schirmer test values, positive vital staining with lissamine green, fluorescein tear break-up time, and tear film osmolarity) when compared to administration of placebo.
FOLLOW-UP VISIT Approximately 90 days after the baseline visit, subjects are scheduled to come to the clinic for their routine• eye check. At that visit, subject's O.SD will be re-assessed by the same examination techniques as the baseline visit. After the examination, the questionnaire will be administered for a second time. The study drug will be discontinued at that visit and standard therapy for the subject's OSO, as deemed necessary by the treating ophthalmologist, will be instituted.
Statement of duration of subject participation:
Subject will be in the study for 3 months. There will be two visits, one is the baseline and second is the follow-up visit. All visits will coincide with their regular clinic visit. The total hours of study participation is no more than 2 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Omega 3 fatty acid
| Arm | Type | Receives |
|---|---|---|
| Fishoil nutritional supplement | Active comparator | Dietary Supplement: Fishoil supplement90 day supply of daily oral administration of a fish oil nutritional supplement (TheraTears Nutrition; Advanced Vision Research, Woburn, MA) |
| Olive oil capsules | Placebo comparator | Dietary Supplement: Olive Oil90 day supply of a daily dose of placebo olive oil capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years
- Typical symptoms of dry eye (photophobia, burning, foreign body sensation, blurred vision improved with blinking)
- OSDI score > 12
- Schirmer Test with Anesthesia < 8 mm/5 minutes
- Fluorescein tear break-up time < 8 seconds
Key exclusion criteria (14 listed)
- Infectious keratoconjunctivitis or inflammatory disease unrelated to dry eye or topical glaucoma medication use
- Patients with severe tear deficiency (defined as Schirmer tes <5 mm/5 min)
- Concomitant ocular pathology
- History of ocular surgery
- Eyelid or eyelash abnormalities
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 |
|---|---|---|
| Fishoil supplement1 capsule per day | Dietary supplement | Fishoil nutritional supplement |
| Olive Oil1 capsule per day | Dietary supplement | Olive oil capsules |
Primary outcome
Ocular Surface Disease Index Score
Time frame: 90 Days
Ocular surface disease validated questionnaire regarding ocular symptoms
3 secondary outcomes
Schirmer test score
Time frame: 90 days
Lissamine Green Staining Score
Time frame: 90 Days
Fluorescein tear break-up time
Time frame: 90 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
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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.
Ahmad A Aref, MD principal investigator
University of Illinois at Chicago College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fishoil supplement and Olive Oil in people with Ocular Surface Disease, run by University of Illinois Chicago 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 6 inclusion and 14 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: withdrawn, as of the sponsor's last update on 28 Feb 2017. 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 withdrawn before enrolling participants, so there are no results.
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?
Ocular Surface Disease Index Score (time frame: 90 Days). 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 28 Feb 2017.