Cataract, Dry Eye DiseasePhase 2/3NCT02260973
The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity
A Phase 2/3 study testing Omega-3 (Triglyceride form) in people with Cataract, Dry Eye Disease, run by Physician Recommended Nutriceuticals at 2 sites in United States.
Trial summary
This is a randomized, masked, placebo controlled study to assess the effect on visual acuity, if any, of the PRN omega-3 nutritional supplement in subjects undergoing cataract surgery. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Cataract, Dry Eye Disease
- What is being tested?
- Omega-3 (Triglyceride form)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2014to Dec 2016
- Phase
- Phase 2/3
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of nuclear or cortical lens opacities in one/both eyes
- Physician diagnosis of age related cataract
- Good overall physical constitution
- All participants must be follow the same regimen for surgery related medications, both pre and post surgery. (Antibiotic, NSAID and Steroid eye drops)
Who cannot join
- Subjects requiring Premium IOLs/multifocal implants
- Advanced cataract
- Severe Age-Related Macular Degeneration Presence or history of Glaucoma
- Presence or history of Diabetes Mellitus
- Any Retinal pathology - retinal detachment, retinitis pigmentosa, diabetic retinopathy, etc
- Vision loss due to Central retinal artery occlusion or Central retinal vein occlusion
Show all 15Show fewer
- Vision loss due to presence of large pituitary tumors or aneurysms
- Vision loss due to optic tract lesions
- Vision loss due to bleeding into aqueous or vitreous chamber
- Vision loss due to drug toxicity: Amiodarone, anti-tuberculosis drugs, hydroxychloroquine, tamoxifen
- Major cardiovascular or cerebral events in the past 12 months
- Allergy to fish oil or safflower oil
- Pregnancy or lactation at any time during the study
- Newly started or increased the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of Screening or at any time during the study
- Participation in any other study involving an investigational drug or device within the past 30 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Southern Eye Associates
Greenville, South Carolina, 29605
Kim Williams, kim.williams@innovativeclinicalresearch.net
- Recruiting
Cincinnati Eye Institute
Lexington, Kentucky, 41017
Rachel Crabtree, 859-331-9000 ext. 4120
About this study
Official title: The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity Outcomes In Cases Undergoing Cataract Surgery: A Pilot Study.
This is a randomized, masked, placebo controlled study to assess the effect on visual acuity, if any, of the PRN omega-3 nutritional supplement in subjects undergoing cataract surgery.
- Conditions
- Cataract, Dry Eye Disease
- Being tested
- Omega-3 (Triglyceride form)
- Medical subject headings
- Cataract, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 (Triglyceride form)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Active comparator | re esterified TG omega-3 Receives: Dietary Supplement: Omega-3 (Triglyceride form) |
| Safflower Oil | Placebo comparator | vegetable oil Receives: Dietary Supplement: Omega-3 (Triglyceride form) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract, Dry Eye DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Physician Recommended Nutriceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bradley Williams, MD, Principal investigator, Southern Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260973
- Sponsor's protocol ID
- PRN 20145
- Status last verified
- Aug 2016
- First submitted
- 6 Oct 2014
- Last updated
- 4 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity Outcomes In Cases Undergoing Cataract Surgery: A Pilot Study.
- ClinicalTrials.gov ID
- NCT02260973
- Acronym / sponsor ID
- PRN 20145
- Conditions
- Cataract, Dry Eye Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Physician Recommended NutriceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Oct 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 is a randomized, masked, placebo controlled study to assess the effect on visual acuity, if any, of the PRN omega-3 nutritional supplement in subjects undergoing cataract surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Active comparator | Dietary Supplement: Omega-3 (Triglyceride form)re esterified TG omega-3 |
| Safflower Oil | Placebo comparator | Dietary Supplement: Omega-3 (Triglyceride form)vegetable oil |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of nuclear or cortical lens opacities in one/both eyes
- Physician diagnosis of age related cataract
- Good overall physical constitution
- All participants must be follow the same regimen for surgery related medications, both pre and post surgery. (Antibiotic, NSAID and Steroid eye drops)
Key exclusion criteria (15 listed)
- Subjects requiring Premium IOLs/multifocal implants
- Advanced cataract
- Severe Age-Related Macular Degeneration Presence or history of Glaucoma
- Presence or history of Diabetes Mellitus
- Any Retinal pathology - retinal detachment, retinitis pigmentosa, diabetic retinopathy, etc
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 (Triglyceride form) | Dietary supplement | Omega-3, Safflower Oil |
Primary outcome
Visual Acuity
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
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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.
Bradley Williams, MD principal investigator
Southern Eye Associates
2 sites 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 (Triglyceride form) in people with Cataract, Dry Eye Disease, run by Physician Recommended Nutriceuticals at 2 sites 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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: 8 weeks). 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 4 Aug 2016.