Open Angle GlaucomaNCT02295358
The Effect of Omega-3 Fatty Acid Supplementation on Intraocular Pressure & Ocular Surface
An observational study of Open Angle Glaucoma and Ocular Hypertension, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study is designed with the intention to further elucidate the effects of omega-3 fatty acids on intraocular pressure (IOP) and signs/symptoms of dry eye. Prior studies have shown statistically significant lowering of IOP with use of omega-3 fatty acids but have only been performed in animal models. Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Nov 2015
- Phase
- Observational
- 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 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosis of Ocular Hypertension or Open Angle Glaucoma of mild to moderate severity, with or without previously diagnosed dry eye syndrome, who are currently on monotherapy with a prostaglandin analog. Age 40-89 of either gender, of any race/ethnicity
Who may be able to join
- Diagnosis of Ocular Hypertension or Open Angle Glaucoma of mild to moderate severity, with or without previously diagnosed dry eye syndrome, who are currently on monotherapy with a prostaglandin analog.
- Age 40-89 of either gender, of any race/ethnicity
Who cannot join
- Females who are currently pregnant or planning to become pregnant during the study period
- Age <40 years old
- Diagnosis of any other form of glaucoma other than open-angle
- Patients with known hypersensitivity (i.e., anaphylactic reaction) to omega-3 fatty acids or any of its components
- Patients with cirrhosis or with known liver disease
- Patients with diagnosed celiac disease
Show all 12Show fewer
- Patients with a hypersensitivity to fish or shellfish
- Patients with paroxysmal or persistent atrial fibrillation
- Patients who are currently using medical or recreational marijuana
- Patients currently on any anticoagulation therapy including warfarin, dabigatran, apixaban, rivaroxaban, clopidogrel, cilostazol, dipyridamole, prasugrel, ticlopidine, ticagrelor
- Patients currently on Lovaza, an omega- 3 fatty acid supplement requiring a prescription
- Patients with any recent ocular surgery or laser treatment within 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Eye Center
Aurora, Colorado, 80045
About this study
This study is designed with the intention to further elucidate the effects of omega-3 fatty acids on intraocular pressure (IOP) and signs/symptoms of dry eye. Prior studies have shown statistically significant lowering of IOP with use of omega-3 fatty acids but have only been performed in animal models. This study will be the first to attempt replication in human models. A limited number of studies have shown an increase in tear production/volume as well as a decrease in the subjective symptoms of dry eye, but more studies are needed to better define these effects. Better understanding of the effects of this supplement on intraocular pressure and dry eye will contribute to the expanding knowledge about the pathophysiology of glaucoma/ocular hypertension and dry eye syndrome and potentially lead to further studies about new potential treatment options for these conditions.
Read the detailed description
The purpose of this research project is to determine the effects of omega-3 fatty acid supplementation on intraocular pressure (IOP) as well as the signs and symptoms of dry eye. We hypothesize that dietary omega-3 fatty acid supplementation will be associated with a significant change in intraocular pressure compared to baseline measurements prior to beginning supplementation. We further hypothesize that omega-3 fatty acid supplementation will be associated with a significant increase in tear production and volume as well as a significant change in patients' subjective complaints of dry eye.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Omega-3 Fatty Acid Supplementation on Intraocular Pressure
Intraocular pressure is measured at the study start, and after three month on supplementation.
Measured: Change in intraocular pressure from baseline over 3 month
Secondary outcomes (1)
The Effect of Omega-3 Fatty Acid Supplementation on Ocular Surface
Tear breakup time, corneal fluorescein staining, and tear osmolarity of Ocular Surface is measured at the study start, and after three month on supplementation
Measured: Change in Ocular Surface from baseline over 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Why it stopped: Project never got initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonard K Seibold, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295358
- Sponsor's protocol ID
- 14-0235
- Status last verified
- Jul 2015
- First submitted
- 13 Nov 2014
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Omega-3 Fatty Acid Supplementation on Intraocular Pressure & Ocular Surface
- ClinicalTrials.gov ID
- NCT02295358
- Acronym / sponsor ID
- 14-0235
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Project never got initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 20 Nov 2014 (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.
This study is designed with the intention to further elucidate the effects of omega-3 fatty acids on intraocular pressure (IOP) and signs/symptoms of dry eye. Prior studies have shown statistically significant lowering of IOP with use of omega-3 fatty acids but have only been performed in animal models. This study will be the first to attempt replication in human models. A limited number of studies have shown an increase in tear production/volume as well as a decrease in the subjective symptoms of dry eye, but more studies are needed to better define these effects. Better understanding of the effects of this supplement on intraocular pressure and dry eye will contribute to the expanding knowledge about the pathophysiology of glaucoma/ocular hypertension and dry eye syndrome and potentially lead to further studies about new potential treatment options for these conditions.
Detailed description
The purpose of this research project is to determine the effects of omega-3 fatty acid supplementation on intraocular pressure (IOP) as well as the signs and symptoms of dry eye. We hypothesize that dietary omega-3 fatty acid supplementation will be associated with a significant change in intraocular pressure compared to baseline measurements prior to beginning supplementation. We further hypothesize that omega-3 fatty acid supplementation will be associated with a significant increase in tear production and volume as well as a significant change in patients' subjective complaints of dry eye.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of Ocular Hypertension or Open Angle Glaucoma of mild to moderate severity, with or without previously diagnosed dry eye syndrome, who are currently on monotherapy with a prostaglandin analog. Age 40-89 of either gender, of any race/ethnicity
Key inclusion criteria (2 listed)
- Diagnosis of Ocular Hypertension or Open Angle Glaucoma of mild to moderate severity, with or without previously diagnosed dry eye syndrome, who are currently on monotherapy with a prostaglandin analog.
- Age 40-89 of either gender, of any race/ethnicity
Key exclusion criteria (12 listed)
- Females who are currently pregnant or planning to become pregnant during the study period
- Age <40 years old
- Diagnosis of any other form of glaucoma other than open-angle
- Patients with known hypersensitivity (i.e., anaphylactic reaction) to omega-3 fatty acids or any of its components
- Patients with cirrhosis or with known liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Effect of Omega-3 Fatty Acid Supplementation on Intraocular Pressure
Time frame: Change in intraocular pressure from baseline over 3 month
Intraocular pressure is measured at the study start, and after three month on supplementation.
1 secondary outcome
The Effect of Omega-3 Fatty Acid Supplementation on Ocular Surface
Time frame: Change in Ocular Surface from baseline over 3 month
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 9 Jul 2015.
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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.
Leonard K Seibold, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Angle Glaucoma and Ocular Hypertension, run by University of Colorado, Denver 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 2 inclusion and 12 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 9 Jul 2015. 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. 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?
The Effect of Omega-3 Fatty Acid Supplementation on Intraocular Pressure (time frame: Change in intraocular pressure from baseline over 3 month). 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 9 Jul 2015.