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M.T. Christensen, C.J. Hearn, D.L. Meadows, J.M. Stein; Results of a Clinical Evaluation with a New Artificial Tear Solution Containing HP-Guar . Invest. Ophthalmol. Vis. Sci. 2003;44(13):2483.
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Purpose: To evaluate the safety and efficacy of a new artificial tear solution containing HP-Guar in mild to moderate dry eye patients compared to a market leader. Methods: 87 patient were enrolled in this randomized, double masked, parallel clinical study. Patients were required to have corneal staining of grade 3 or greater (using the NEI corneal staining grid) at both the screening (Day –7) and eligibility visits (Day 0) to be enrolled. In addition, they had to answer a questionnaire indicating they needed artificial tears at least "some of the time" due to their dry eye condition. If eligible, subjects were randomized to either the test or control formulations. The test product contained polyethylene glycol and propylene glycol as demulcents along with a novel polymer system (0.18% HP-Guar) and was preserved with Polyquad. The control contained 0.5% carboxymethylcellulose and was preserved with Purite. The study required that both test and control products be used a minimum of 4 times/day for the duration of the study (6 weeks on product). Other measures included Lissamine Green Staining, Tear-Breakup-Time with the DET test, Schirmer Test w/o anesthesia, Ocular Comfort and Drop Acceptability questions. Results: Subjects that were randomized to the test solution showed a statistically significant reduction in temporal corneal staining and conjunctival staining compared to the control. Both test and control demonstrated a significant reduction in corneal staining from baseline. There were also significant differences in favor of the test product with less morning dryness, end of day dryness and less foreign body sensation than the control. The test product did cause more initial blurring for the first 30 seconds post instillation at Day 42. No significant differences were noted with any of the other signs/symptoms evaluated. Conclusions: This study demonstrated that a palliative treatment could significantly reduce both signs and symptoms associated with dry eye compared to another marketed artificial tear solution.
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