Omega-3s from fish oil supplements no better than placebo for dry eye15 Apr 2018
NIH-funded study finds omega-3 fails to yield beneficial results in the clinic.
Omega-3 fatty acid supplements taken orally proved no better than placebo at relieving symptoms or signs of dry eye, according to the findings of a well-controlled trial funded by the National Eye Institute (NEI), part of the National Institutes of Health.
“The trial provides the most reliable and generalizable evidence thus far on omega-3 supplementation for dry eye disease,” said Maryann Redford, program officer for clinical research at NEI. Despite insufficient evidence establishing the effectiveness of omega-3s, clinicians and their patients have been inclined to try the supplements for a variety of conditions with inflammatory components, including dry eye. “This well-controlled investigation conducted by the independently-led Dry Eye Assessment and Management (DREAM) Research Group shows that omega-3 supplements are no better than placebo for typical patients who suffer from dry eye.”
The 27-center trial enrolled 535 participants with at least a 6-month history of moderate to severe dry eye. Among them, 349 people were randomly assigned to receive 3 g daily of fish-derived omega-3 fatty acids in five capsules. Each daily dose contained 2000 mg eicosapentaenoic acid (EPA) and 1000 mg docosahexaenoic acid (DHA). This dose of omega-3 is the highest ever tested for treating dry eye disease. The 186 people randomly assigned to the placebo group received 5 g daily of olive oil (about 1 teaspoon) in identical capsules. Study participants and the researchers did not know their group assignment.
Blood tests at 12 months confirmed that 85% of people in the omega-3 group were still compliant with the therapy. In the omega-3 group, mean EPA levels quadrupled versus no change in the placebo group. Mean levels of oleic acid, the constituent of olive oil, remained stable in both treatment groups.
Importantly, unlike in most industry-sponsored trials, all participants were free to continue taking their previous medications for dry eye, such as artificial tears and prescription anti-inflammatory eye drops.
“Omega-3s are generally used as an add-on therapy. The study results are in the context of this real-world experience of treating symptomatic dry eye patients who request additional treatment,” said study chair for the trial, Penny A. Asbell, of the Department of Ophthalmology at the Icahn School of Medicine at Mount Sinai in New York City.
Patient-reported symptoms were measured as change from baseline in the Ocular Surface Disease Index, a 100-point scale for assessing dry eye symptoms, with higher values representing greater severity. After 12 months, mean symptoms scores for people in both groups had improved substantially, but there was no significant difference in the degree of symptom improvement between the groups. Symptom scores improved by a mean of 13.9 points in the omega-3 group and 12.5 points in the placebo group. A reduction of at least 10 points on the index is considered significant enough for a person to notice improvement. Overall, 61% of people in the omega-3 group and 54% of those in the control group achieved at least a 10-point improvement in their symptom score, but the difference between the groups was not statistically significant.
Likewise, there were no significant differences between the groups in terms of improvement in signs of dry eye. Signs of dry eye were evaluated by the clinician using standardized tests that measure the amount and quality of tears and the integrity of the cornea and the conjunctiva, the surface tissue that covers the front of the eye.
“The findings also emphasize the difficulty in judging whether a treatment really helps a particular dry eye patient,” said the leader of the coordinating center for the study, Maureen G. Maguire, of the Department of Ophthalmology at the Perelman School of Medicine at the University of Pennsylvania, Philadelphia. “More than half the people taking placebo reported substantial symptom improvement during the year-long study.”
“The results of the DREAM study do not support use of omega-3 supplements for patients with moderate to severe dry eye disease,“ Dr. Asbell concluded.
Dry eye disease occurs when the film that coats the eye no longer maintains a healthy ocular surface, which can lead to discomfort and visual impairment. The condition affects an estimated 14% of adults in the US. The paper was published online April 13 in the New England Journal of Medicine.
EU FMD - time is running out!
13 Nov 2018
Companies that have left it too late to implement their own solution will have to rely on support from providers, whose resources are already in high demand as the deadline approaches.Read more
Proprietary nasal delivery formulation of diazepam reaches NDA
7 Nov 2018
The absolute bioavailability of the Valtoco intranasal formulation was 96% of intravenous diazepam in a Phase I cross-over trial.Read more
DSCSA one-month countdown!
30 Oct 2018
With only a month to go, it really is too late to start trying to develop an in-house solution.Read more
Global pharma set for strong year
23 Oct 2018
Eight of the top ten pharma nations reporting improving market conditions.Read more
Generics companies to move away from "little white pills"
14 Oct 2018
Accepting more complexity and risk is key for those generics companies seeking competitive differentiation by diversifying their product portfolios.Read more
CMOs to benefit from double digit approvals for ADCs in the next 3 years
9 Oct 2018
Therapeutic ADC market expected to reach $4 billion by 2023.Read more
Movement on the market reflected at CPhI Worldwide 2018
3 Oct 2018
Companies new to CPhI to showcase an exciting range of products and services ranging from electroceuticals to refrigerant alternatives.Read more
Sanofi to refocus two global business units
19 Sep 2018
The new Primary Care and China & Emerging Markets global business units are expected to launch at the beginning of 2019.Read more
Moulds & Tooling: A European success story
19 Sep 2018
While not quite an endangered species, the past fifteen years have not been easy ones for many European mould makers. Many, but not all, and IGS GeboJagema is a case in point – a case that shows the difference automation and focus can make. By Karen La...Read more
Experts warn trade and patent changes could increase healthcare cost by $100bn over next 5 years
18 Sep 2018
China is harmonizing to ICH standards at feverish pace and will force poor quality manufacturers out of market.Read more
Are you a supplier
Here's what we can do for you
- Generate quality leads for your business
- Stay visible for 365 days of the year
- Receive product inquiries and respond to meeting requests directly
- Improve company online presence through Search Engine Optimisation