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Jing Liu, Fangfang Qiu, Hui Zhao, Jingyao Chen, Jerry Paugh, Joseph Griffin, Benny Li, Zhixin Wang, Zuguo Liu; Ocular Surface Dwell Time of Artificial Tears Measured with Fluorometry in Chinese Dry Eye Patients. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3848.
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To evaluate the ocular surface retention time (RT) of a new lubricant eye drop, Polyethylene Glycol/Propylene Glycol (PEG/PG, Systane® Ultra) compared with Sodium Hyaluronate (HA, Hialid) in Chinese dry eye patients.
This was a double masked, randomized, single eye (worse eye) 3-way crossover study design in confirmed dry eye patients. Subjects had to have 2 of the following at screening: dry eye symptom score ≥ 5 (modified Schein Questionnaire); sodium fluorescein (NaFl) breakup time < 7 sec; and either NaFl corneal staining total score ≥ 3 (5 corneal sectors, 0-3/sector, maximum score of 15) OR rose bengal conjunctival staining > 4 (6 sectors, 0 - 3/ sector, maximum score of 24) and evidence of MGD (gland dropout or altered expression or both). The study eye was the eye with the most corneal staining. Three formulations were evaluated: a PEG/PG based tear, a hyaluronic acid-based (HA) tear and a control (non-preserved saline). Formulations were admixed with a fluorescein labeled dextran of ~ 70,000 MW (at 0.1% wt/vol) and residence time estimated using a scanning fluorometer. Twenty-five microliter drops were instilled into the inferior fornix using a positive displacement pipette.
Mean (+/- SD) residence times in minutes were 32.9 (9.8), 26.8 (3.5) and 22.7 (12.0) for PEG/PG, HA and saline, respectively (n = 10 for an interim analysis with final sample size target of 25). Compared to control, PEG/PG increased RT 44%, while HA increased it 18%. PEG/PG demonstrated 6 min greater ocular surface RT when compared with HA.
In ethnic Chinese non-aqueous deficient dry eye subjects, RT differences between PEG/PG and HA were observed. These differences mirrored formulation differences and were clinically meaningful compared to non-viscous saline.
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