Summary
- According to a Reuters report Phase 3 trial results showed that the eye drops helped improve vision in some people with night vision problems.
- By the 15th day the improvement rate increased to 21% among those using the eye drops while it remained at 3% in the placebo group.
- The average score among people using the eye drops fell from 4.3 on the eighth day to 3.3 on the 15th day.
Night driving can be difficult for people who struggle with bright headlights glare, halos or starburst like rays around lights. A new eye drop treatment may offer hope for people facing these problems.
Developed by US based company Opus Genetics the eye drops have shown encouraging results in late-stage clinical trials. The treatment is being studied for people who have difficulty seeing clearly in low light or dark conditions.
According to a Reuters report Phase 3 trial results showed that the eye drops helped improve vision in some people with night vision problems.
Promising clinical trial results
The first trial included 145 people who had trouble seeing in dim light or darkness. Many participants also experienced glare, halos and star shaped rays around lights.
Participants received either 0.75% phentolamine eye drops or a placebo once a day. The treatment lasted either eight or 15 days.
After eight days 13% of people using the eye drops showed an improvement of at least three lines or 15 letters, on an eye chart. In comparison only 3% of the placebo group showed similar improvement.
By the 15th day the improvement rate increased to 21% among those using the eye drops while it remained at 3% in the placebo group.
Participants also rated the severity of their night vision problems on a scale of one to seven.
A lower score meant fewer problems.
The average score among people using the eye drops fell from 4.3 on the eighth day to 3.3 on the 15th day. In the placebo group the scores were 4.6 and 4.3, respectively.
The researchers also reported that people using phentolamine experienced less difficulty with glare halos and starburst effects by the 15th day.
How do the eye drops work?
Researchers say the drops work on a muscle in the iris causing the pupil to become smaller in a controlled and steady way. This effect may last for at least 20 hours.
Some participants developed night vision problems after treatments that changed the shape of the cornea, including LASIK surgery. LASIK is commonly used to correct problems such as short sightedness long sightedness and astigmatism.
More testing shows encouraging results
Opus Genetics has also reported early results from another Phase 3 trial. According to the company participants reported improvements in seeing the road when facing bright headlights and less difficulty with glare during morning or evening hours.
The US Food and Drug Administration (FDA) has already granted the eye drops Fast Track designation for the treatment of severe and persistent night driving vision problems.
Fast track status is given to certain treatments that may address serious medical conditions or important unmet medical needs. It can help speed up communication and parts of the regulatory review process.
However despite the encouraging trial results the eye drops still need to complete the required regulatory process before they can receive final approval and become widely available.
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