Abstract
Purpose:
Blepharitis is a common, chronic eye condition that manifests as an inflammation of the eyelids. Usual treatments include lid hygiene, topical steroids, and antibiotics either alone or in combination. While patients “learn to live” with blepharitis, it does have an impact on quality of life (QOL). Currently, no validated QOL questionnaire is available to measure this impact. As part of a double-blinded, clinical trial of alternative treatment protocols, we designed a questionnaire to assess the impact of treatment on the QOL of blepharitis patients.
Methods:
Thirteen questions about clinical signs and symptoms were administered to 900 blepharitis patients throughout a phase III clinical trial. Upon enrollment into the trial, all patients underwent a lid hygiene regimen for at least one week. If blepharitis signs and symptoms persisted after the hygiene treatment, patients were randomized into one of four groups that received treatment for two weeks with either: placebo (N = 150), azithromycin alone (N = 150), dexamethasone alone (N = 300), or a combination of azithromycine and dexamethasone (N = 300). To examine trends in responses and while still blinded to treatment assignments, preliminary analyses of 875 patients compared answers to the 13 questions at the beginning and end of treatment. Exploratory cluster analyses examined whether the QOL questionnaire might effectively differentiate between the four experimental groups at the end of the treatment period.
Results:
Sixty-seven percent of patients received a treatment containing a corticosteroid, which should result in a measurable regression in clinical signs and symptoms at the end of treatment. Across the 13 signs and symptoms measured, on average, 40-55% of patients reported a reduction in symptoms, 40-50% of patients reported no change in symptoms, and 8-10% of patients reported an increase in symptoms. Reports of “lid irritation” showed the greatest improvement, with 54.9% of patients reporting that symptoms were reduced at the end of treatment; reports of “eye lids stuck together” exhibited the least improvement with 28.4% reporting that symptoms were reduced.
Conclusions:
Preliminary findings suggest QOL can be measured in blepharitis patients. Next steps include analyzing how patient reported outcomes compare with clinical data from the same patients.
Keywords: 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials •
557 inflammation •
468 clinical research methodology