An open-label evaluation of HP-Guar gellable lubricant eye drops for the improvement of dry eye signs and symptoms in a moderate dry eye adult population.

OBJECTIVE: Evaluate the efficacy of a polymer hydroxypropyl guar (HP-Guar) gellable lubricant eye drop (Systane* Lubricant Eye Drops) in reducing dry eye signs and symptoms among dry eye patients who exhibited at least moderate signs and symptoms.
METHODS: 168 patients with moderate dry eye signs and symptoms were enrolled at 29 sites in this open label study. The mean age of patients was 62 years with a minimum age of 28 years and a maximum of 90 years. One hundred and forty-seven patients completed the study, 111 female and 35 male, excluding 1 subject (gender not captured). In order to be included in the study, subjects were required to have a total corneal staining score > or = 4 (NEI grid) in at least one eye, with a grade > or = 2 in at least one zone of the same eye. Patients also had to indicate that their eyes 'felt dry enough to want to use eye drops' at least 'some of the time' on a standardized frequency scale. Eligible patients were dispensed a run-in drop (Opti-Free Express Rewetting Drops*) to use QID for 7 days, and then examined. Patients continuing to meet the inclusion criteria were dispensed the test drops (HP-Guar gellable lubricant eye drops) to use QID, and re-examined on Day 28. At each visit, corneal and conjunctival staining were measured, and six ocular discomfort symptoms were rated on a standardized 0-4 severity scale. At Days 0 and 28, patients subjectively rated product acceptability using a Likert scale.
RESULTS: No significant changes in corneal or conjunctival staining were observed with the use of the run-in drop. After 28 days of test drop use, there was a statistically significant reduction in corneal staining (p < 0.0001). Ninety-four percent of patients improved from baseline, with mean reduction in total corneal staining of 4.1 units (0-15 total scale) (62%). Conjunctival staining also improved significantly (p < 0.0001) with a mean total reduction of 3.1 (59%). Patients experienced statistically significant symptomatic relief from day 0 to day 28 for all six ocular discomfort severity questions (p < 0.0001).
CONCLUSION: Lubricating drops effectively relieved signs and symptoms associated with moderate dry eye, with measurable improvements evident in both objective staining and subjective questionnaire measures after 28 days in this study population.