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Ophthalmic epinastine safe and effective for allergic conjunctivitis EPINASTINE HCl 0.05% ophthalmic solution offers a safe and effective alternative for patients with seasonal allergic conjunctivitis, according to clinical studies presented at the annual meeting of the Association for Research in Vision and Ophthalmology. In a multicentre randomised controlled trial involving 298 patients diagnosed with seasonal allergic conjunctivitis, there was a statistically significant benefit for epinastine, compared to the vehicle alone for itch (p=0.05). The patients in the double-masked study had a mean age of 37 years, but some were as young as nine. The protocol assigned 188 patients to receive epinastine HCl 0.05% or levocabastine 0.05%, while the remaining 62 were assigned to the vehicle group. The drugs were administered in both eyes, twice daily for eight weeks. Ocular itching was graded during two seven-day periods of maximal pollen counts. On a scale with zero representing no itch and 4.0 being extremely severe pruritus, epinastine yielded the best result, with an average daily itch score of 0.45. The average score for patients receiving levocabastine was 0.60, while that of those receiving vehicle alone was 0.85, the least favourable score. No statistical difference in redness was seen between treatment groups. Another, single-centre study evaluated the safety and tolerability of epinastine in healthy adults over a six-week period. There were 180 patients in the randomised double-blind study, 40.6% male and 59.4% female, ranging in age from 18 to 77 years, with a mean age of 41 years. Two-thirds of the patients received epinastine HCl 0.05% solution and the remaining 60 were given a vehicle alone, which served as a placebo. Patients received one drop in each eye for six weeks. The participants underwent a biomicroscopy examination and their visual acuity was checked on four different occasions. Few adverse events were observed with active treatment. In fact, patients treated with the vehicle had a slightly higher incidence of adverse events. The researchers saw no differences between treatment and placebo groups in terms of biomicroscopy findings, visual acuity or intraocular pressure measured over the six-week treatment period. Another study measured the concentration of epinastine in the tear fluid and systemic circulation of 14 patients. All the patients had allergy symptoms, with itchy and red eyes. They were given HCl 0.05% ophthalmic solution eye drops for seven days in a row, with one drop in each eye the first day, followed by two drops a day until the last day when the dose was increased to three drops. Blood samples were taken on four different occasions to determine drug concentrations in the patients' blood. On the last day, tear fluid was collected. No adverse events were found, nor were there any clinically relevant changes in visual acuity, biomicroscopy, ophthalmoscopy, vital signs, physical examination outcomes or laboratory parameters. Epinastine is an antihistamine with mast cell stabilising properties. Epinastine HC1 0.05% ophthalmic solution has already been approved in Europe , while in the United States , a new drug application is currently under review by the Food and Drug Administration.
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