Omega-3s from fish oil supplements no better than placebo for dry eye

15 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.

Omega-3s from fish oil supplements no better than placebo for dry eye

“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.

Read More

Related news

'Tamper-evident' benefits are evident

'Tamper-evident' benefits are evident

28 Feb 2019

2019 will mark Uniplast's debut at this year's edition of CPhI Worlwide in Frankfurt, where it will showcase its expertise in plastic packaging.

Read more 
All Recipharm facilities ready for EU serialisation, regardless of Brexit

All Recipharm facilities ready for EU serialisation, regardless of Brexit

15 Feb 2019

The CDMO invested EUR 35 million into its operations and launched a 3-year programme to provide a compliant serialisation solution for its customers.

Read more 
Brexit - the EU FMD's painful problem

Brexit - the EU FMD's painful problem

7 Feb 2019

Teething problems are no stranger to the implementation of new regulations, but with the EU FMD, Brexit came like a set of wisdom teeth – late, painful and problematic.

Read more 
Pharmapack report predicts diversification of innovation leading to a rise in licensing and partnering

Pharmapack report predicts diversification of innovation leading to a rise in licensing and partnering

27 Jan 2019

New report highlights Germany, France and Switzerland as tier-one nations for ‘drug delivery innovation’, and warns the challenge will be to scale-up and approve promising prototypes.

Read more 
New API screening program strengthens Particle Sciences' nanomilling offering

New API screening program strengthens Particle Sciences' nanomilling offering

22 Jan 2019

Advanced formulation techniques such as nanomilling may provide an excellent route to improved bioavailability and enhanced therapeutic effect.

Read more 
Univercells introduces breakthrough vaccine manufacturing platform

Univercells introduces breakthrough vaccine manufacturing platform

13 Jan 2019

The automated NevoLine bioproduction system that facilitates safer, faster and closed bioprocessing in a much smaller footprint.

Read more 
BMS and Celgene merge to create premier innovative biopharma company

BMS and Celgene merge to create premier innovative biopharma company

3 Jan 2019

Significantly expands Phase III assets with six expected near-term product launches, representing greater than $15 billion in revenue potential.

Read more 
An increased risk of a hard or ‘no deal Brexit?

An increased risk of a hard or ‘no deal Brexit?

24 Dec 2018

A ‘no deal’ Brexit will change and burden how all industries that move materials and goods across borders, including the pharmaceutical and medical device sectors, do business.

Read more 
One month on: medical cannabis is still taboo despite change in law

One month on: medical cannabis is still taboo despite change in law

11 Dec 2018

Restrictive guidelines have led many to buy CBD products online, leading to a boom in production with many products going to market without sufficient quality control.

Read more 
EU FMD - time is running out!

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