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K.N. Sall, S.M. Cohen, M.T. Christensen; Efficacy and Compatibility of an HP–Guar Based Lubricant Eye Drop When Used as Supportive Therapy With a Cyclosporine–Based Ophthalmic Emulsion . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2020.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: To evaluate the efficacy and compatibility of two marketed artificial tears in relieving dry eye signs/symptoms when used as supportive therapy to a cyclosporine based ophthalmic emulsion. Methods: 60 patients were evaluable by intent–to–treat analysis for this randomized, investigator masked, parallel study of 6–months duration. Enrollment criteria included corneal staining of > 3 (NEI grid), Schirmer w/o anesthesia of < 7mm and subjects had to answer that they needed artificial tears at least "some of the time". Subjects were randomized to one of 3 treatment groups. Treatment (Tx)1: Restasis® (0.05% cyclosporine) BID w/Systane® (PEG 400/propylene glycol w/HP–Guar as a gelling agent) used a minimum of 1/day as supportive therapy. Tx2: Restasis® BID w/Refresh Tears® (carboxymethylcellulose) used a minimum of 1/day as supportive therapy. Tx3: Systane used alone QID. Signs and symptoms were measured at Days –7, 0, 7, 14, 28, 42, 120 and 180. Results: A statistical difference was seen in favor of Tx1 (Restasis+Systane) vs Tx2(Restasis+Refresh) for greater reduction in corneal staining (p=0.0048) and a trend (p=0.0725) for increased TFBUT at 6 months. Schirmer showed non–significant increases from baseline at 6 months: Tx1=1.41, Tx2=2.15, Tx3=1.42 mm. Significant differences were seen in favor of Tx1 vs Tx2 for less frequent ocular burning (p=0.0210), stinging (p=0.0314), grittiness (p=0.0128) and dryness (p=0.0132). Tx3 (Systane alone) was better than Tx2 (Restasis+Refresh) for less frequent ocular burning (p=0.0288), dryness (p=0.0480) and scratchiness (p=0.0294). Conclusions: The choice of artificial tears used as supportive therapy with Restasis has significant indications for outcome measures. There were significant clinical advantages with Restasis+Systane vs Restasis+Refresh Tears. There were no clinical or statistical differences seen between Restasis+Systane vs Systane used alone. Both supportive therapies were compatible with Restasis.
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