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J. Luchs; Efficacy of Hydroxypropyl Cellulose Ophthalmic Inserts (HCOI) in Dry Eye Syndrome (DES) at All Levels of Severity. Invest. Ophthalmol. Vis. Sci. 2010;51(13):6262.
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To determine the efficacy of HCOI across all levels of DES severity.
This 2-visit, open-label, multicenter patient registry enrolled 520 patients with DES. Symptoms, ADL limitations, and degree of ocular discomfort in various environmental conditions for the month prior to Visit 1 (baseline) and during treatment were rated using the Ocular Surface Disease Index (OSDI) and ADL questionnaires. Tear film break up time (TFBUT) was also measured. HCOI was inserted once daily alone or along with existing therapy.
In patients who completed the study (N=418), analysis of variance (ANOVA) showed significant differences in OSDI scores between severity groups. The largest decrease in scores was seen in the severe group, (29.8%, P<.001). Scores in the moderate group decreased by 18.9% (P=.016). There were significant increases of 83.7% (P=.001) and 30.2% (P=.01) for normal and mild groups, respectively. Fig 1At baseline, 65.3% of patients who completed the study scored within the severe range; after 1 month of therapy, 44% of the group scored within the severe range, shifting the distribution to normal, mild, and moderate groups. ANOVA showed no significant between-group difference in TFBUT. There was a significant increase in TBUT for the left eye in the normal group (P<.05) compared to baseline, but no increases in either eye for mild or moderate groups. In the severe group there was a significant increase in TFBUT for both eyes (P<.005) compared to baseline. Blurred vision was the most commonly reported adverse effect.
HCOI monotherapy or adjunctive therapy improved symptoms and functioning after 1 month in patients with moderate-to-severe DES. Patients with normal or mild DES had significant increases on the OSDI, possibly influenced by treatment side effects. A shift in the distribution of patients from severe to less severe was also noted.
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