Nav: Home

New treatment for severe dry eye disease promising in early clinical trials

May 07, 2019

Participants in a phase I/II clinical trial of a new enzyme-based treatment for severe dry eye disease experienced reduced signs of disease and discomfort, according to a paper in Translational Vision Science and Technology.

The trial compared eye drops containing a biosynthetic form of an enzyme called DNase with eye drops without the enzyme. DNase breaks up nucleic acid-based material on the surface of the eye.

"Participants in the trial who used the drops with DNase reported less eye discomfort and their corneas were healthier," said Dr. Sandeep Jain, professor of ophthalmology and visual sciences in the University of Illinois at Chicago College of Medicine and principal investigator of the clinical trial.

In dry eye disease, production of tears is dysregulated, and the cornea, the transparent outer layer of the eye, becomes inflamed. In severe dry eye disease, which often accompanies diseases such as Sjogren's syndrome and ocular graft-versus-host disease, the inflammation in the corneal tissue can become extreme enough to cause disabling eye pain and sensitivity to light.

In previous research, Jain and colleagues discovered that strands of DNA form webs on the surface of eyes affected by severe dry eye disease. This material causes an inflammatory response that further irritates the eye.

"In dry eye disease, several things happen," Jain explained. "There is an increase in the number of white blood cells called neutrophils that gather on the surface of the eye. Neutrophils release DNA which forms webs on the cornea called neutrophil extracellular traps, which cause inflammation of the ocular surface and attract additional neutrophils in a vicious cycle."

Normally, enzymes present in tears chop up and clear DNA and other debris on the cornea, but in patients with dry eye disease, there is not enough DNase to clear the material.

In the randomized, placebo-controlled phase I/II clinical trial, Jain and colleagues enrolled 47 participants with severe dry eye disease. About half the participants had a diagnosis of Sjogren's syndrome and 17% had graft-versus-host disease -- both of which are associated with significant deficits in tear production. Forty-one participants completed the trial.

Participants were given eye drops containing either DNase or a placebo formulation and instructed to administer one drop of the solution to each eye four times per day for eight weeks. The researchers evaluated patients' symptoms through questionnaires and measured the degree of corneal damage and amount of DNA webs and other pro-inflammatory material on the surface of the eye before and for the duration of the study.

The researchers found that participants in the DNase group had a statistically significant and clinically meaningful reduction in corneal damage at eight weeks compared with the placebo group. Questionnaire scores related to symptoms also reflected significant improvement among patients in the DNase group compared with placebo, who also had reduced amounts of corneal DNA webs and other material on the surface of the eye.

"The data from this early clinical trial suggests that DNase eye drops may be safe and effective for treating severe dry eye, and we look forward to conducting larger randomized trials to definitively prove its efficacy," Jain said.

DNase is currently approved by the U.S. Food and Drug Administration to treat cystic fibrosis. Its use for treating severe dry eye that doesn't respond to other medications is still considered experimental by the FDA.

"The burden of severe dry eye is much greater than just having an occasional feeling of dryness," Jain said. "It can severely compromise quality of life to the point of disability and can compromise a person's vision. There are currently only two approved drugs to treat dry eye, and they don't work for everyone, especially those with severe disease, so having a new drug that can treat the disease is very important."
-end-
Christine Mun, Shilpa Gulati, Sapna Tibrewal, Yi-Fan Chen, Seungwon An, Bayasgalan Surenkhuu, Ilangovan Raju, Morgan Buwick, Anna Ahn, Ji-Eun Kwon, Nour Atassi, Anubhav Pradeep and Dr. Damiano Rondelli are co-authors on the paper.

This research was supported by Genentech, National Eye Institute grants R01 EY024966 and P30 EY001792, a Research to Prevent Blindness Physician Scientist Award and a UIC Chancellor's Innovation Fund Award. Jain is the inventor on a patent assigned to the University of Illinois at Chicago that covers the use of DNase to treat dry eye disease.

University of Illinois at Chicago

Related Clinical Trial Articles:

Clinical trial investigates gabapentin for alcohol use disorder
This randomized clinical trial investigated if gabapentin, a drug often used to treat nerve pain, would be useful in the treatment of patients with alcohol use disorder (problem drinking that becomes severe) and a history of alcohol withdrawal symptoms.
Electrical stimulation helps treat constipation in clinical trial
Electrical stimulation benefited women with constipation in a recent clinical trial published in Alimentary Pharmacology & Therapeutics.
Treatment of migraine pain in randomized clinical trial
Adults experiencing a migraine of moderate or severe severity took the drug ubrogepant or placebo and reported if after two hours they were free of pain and of their most bothersome migraine-associated symptom in this randomized clinical trial.
First entirely digital clinical trial encourages physical activity
As little as a daily ping on your phone can boost physical activity, researchers from the Stanford University School of Medicine and their collaborators report in a new study.
HIV vaccine nears clinical trial following new findings
A promising vaccine that clears an HIV-like virus from monkeys is closer to human testing after a new, weakened version of the vaccine has been shown to provide similar protection as its original version.
Sickle cell drug showing promise in clinical trial
An investigational drug for the treatment of sickle cell disease is showing early promise in clinical trials for impacting biomarkers of the disease in patients, reported UConn School of Medicine researchers.
Meditation goes digital in new clinical trial
Scientists at UC San Francisco have developed a personalized digital meditation training program that significantly improved attention and memory in healthy young adults -- a group already at the peak of brain health -- in just six weeks.
Could blockchain ensure integrity of clinical trial data?
UC San Francisco researchers have created a proof-of-concept method for ensuring the integrity of clinical trials data with blockchain.
Eating crickets can be good for your gut, according to new clinical trial
A new clinical trial shows that consuming crickets can help support the growth of beneficial gut bacteria and that eating crickets is not only safe at high doses but may also reduce inflammation in the body.
Idera Pharmaceuticals presents clinical data from the ILLUMINATE-204 trial of the combination of tilsotolimod and ipilimumab for anti-PD-1 refractory metastatic melanoma at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting
Idera Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with rare cancers and rare diseases, announced results from the ongoing ILLUMINATE-204 trial investigating tilsotolimod, Idera's intratumorally-delivered Toll-like Receptor 9 agonist, in combination with ipilimumab (Yervoy®).
More Clinical Trial News and Clinical Trial Current Events

Trending Science News

Current Coronavirus (COVID-19) News

Top Science Podcasts

We have hand picked the top science podcasts of 2020.
Now Playing: TED Radio Hour

Listen Again: Reinvention
Change is hard, but it's also an opportunity to discover and reimagine what you thought you knew. From our economy, to music, to even ourselves–this hour TED speakers explore the power of reinvention. Guests include OK Go lead singer Damian Kulash Jr., former college gymnastics coach Valorie Kondos Field, Stockton Mayor Michael Tubbs, and entrepreneur Nick Hanauer.
Now Playing: Science for the People

#562 Superbug to Bedside
By now we're all good and scared about antibiotic resistance, one of the many things coming to get us all. But there's good news, sort of. News antibiotics are coming out! How do they get tested? What does that kind of a trial look like and how does it happen? Host Bethany Brookeshire talks with Matt McCarthy, author of "Superbugs: The Race to Stop an Epidemic", about the ins and outs of testing a new antibiotic in the hospital.
Now Playing: Radiolab

Speedy Beet
There are few musical moments more well-worn than the first four notes of Beethoven's Fifth Symphony. But in this short, we find out that Beethoven might have made a last-ditch effort to keep his music from ever feeling familiar, to keep pushing his listeners to a kind of psychological limit. Big thanks to our Brooklyn Philharmonic musicians: Deborah Buck and Suzy Perelman on violin, Arash Amini on cello, and Ah Ling Neu on viola. And check out The First Four Notes, Matthew Guerrieri's book on Beethoven's Fifth. Support Radiolab today at Radiolab.org/donate.