A recent study found that the first punctum plug developed to treat inflammation and pain following cataract surgery has been shown to be a reliable alternative to medicated eye drops.
Chicago-A recent study found that the first punctum plug developed to treat inflammation and pain following cataract surgery has been shown to be a reliable alternative to medicated eye drops.
The punctum plug automatically delivers the correct amount of postoperative medication in patients, potentially solving the issue of poor compliance with self-administering eye drops.
“The use of a punctual plug for drug delivery would be appreciated by most elderly patients, who have difficulty instilling drops,” says Optometry Times Editorial Advisory Board member Tracey Schroeder Swartz, OD, MS. “If the patient uses the typical topical antibiotic, NSAID and steroid regime, it would reduce the amount of drops by 70 per eye.”
After cataract surgery, most patients are prescribed topical eye drops to reduce ocular inflammation that often occurs after surgery, but many do not or are not able to comply with the recommended dosing regimen. To potentially eliminate the problem of compliance, patients who had received cataract surgery from four ophthalmology practices across the U.S. were selected to participate in this Phase 2 study. The researchers tested punctum plugs designed to deliver a sustained release of the anti-inflammatory pain medication dexamethasone to the eye over a period of 30 days following the removal of cataracts. After 30 days, the plug softens, liquefies and is cleared through the tear duct without the need for removal. The researchers concluded that when compared to a placebo, the dexamethasone punctum plug provides sustained reductions of inflammation and pain for up to one month following cataract surgery.
“Most people who have cataract surgery are older and may have a difficult time adhering to a post-operative eye drop regimen for various reasons," says Thomas Walters, MD, an ophthalmologist at Texan Eye in Austin, TX and lead researcher for the study. “Getting eye drops onto the eye can be difficult for anybody, especially those who might have trouble holding the bottle or targeting the drops onto the eye. The punctum plug eliminates those variables and will make recovering from surgery far easier for cataract patients.”
The 60 participants were randomly split into two groups, with one group of 30 patients receiving a placebo vehicle punctum plug and the other group of 30 patients receiving a dexamethasone-medicated punctum plug. At various points throughout the 30 days following cataract surgery, the researchers assessed the number of patients in both groups with ocular inflammation (measured by the presence of anterior chamber cells in the treated eye) and pain.
They found that the medicated plug group had significantly less pain throughout the 30 days. On Day 1, the placebo group reported a mean ocular pain score more than three times higher than the medicated plug group. By Day 14, the placebo group reported a mean ocular pain score 11 times higher than the medicated plug group, remaining at this level through the conclusion of the study.
Ocular inflammation in the medicated plug group was also significantly less than the placebo group throughout the 30 days. By Day 14, more than 30 percent of patients in the medicated plug group showed no ocular inflammation, compared to just three percent in the placebo group. By Day 30 of the study, more than 60 percent of the patients in the medicated plug group had no signs of inflammation compared to 13 percent of patients in the placebo group.
Significantly fewer patients in the medicated plug group required additional anti-inflammatory medications compared to those in the placebo group. Furthermore, a lower percentage of the medicated plug group reported experiencing light sensitivity compared with placebo patients at Day 1 (44.8 percent vs. 65.5 percent) and Day 4 (37.9 percent vs. 56.7 percent).
Based on the results of this study, the product is being evaluated further in Phase 3 clinical trials. This study was supported by Ocular Therapeutix, which developed the dexamethasone punctum plug.
“I would be more excited if the plug used prednisolone acetate rather than dexamethasone, but the pressures were not reported to go up in the study,” says Dr. Swartz. “Because technicians can instill plugs, this would be an easy change for surgeons. Since we are sensitive to using generic drops, which may not remain properly in suspension, the plug may be a better option.”