Volume 119, Issue 10, Pages (October 2012)

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Volume 119, Issue 10, Pages 1954-1960 (October 2012) Efficacy and Safety of Diquafosol Ophthalmic Solution in Patients with Dry Eye Syndrome: A Japanese Phase 2 Clinical Trial Yukihiro Matsumoto, MD, Yuichi Ohashi, MD, Hitoshi Watanabe, MD, Kazuo Tsubota, MD Ophthalmology Volume 119, Issue 10, Pages 1954-1960 (October 2012) DOI: 10.1016/j.ophtha.2012.04.010 Copyright © 2012 American Academy of Ophthalmology Terms and Conditions

Figure 1 The study protocol was a randomized, multicenter, doubled-masked, placebo-controlled, parallel-group phase 2 clinical study to evaluate the efficacy and safety of 1% and 3% diquafosol ophthalmic solutions in patients with dry eye with a 2-week washout period followed by a 6-week treatment period. Ophthalmology 2012 119, 1954-1960DOI: (10.1016/j.ophtha.2012.04.010) Copyright © 2012 American Academy of Ophthalmology Terms and Conditions

Figure 2 The change in fluorescein (FL) corneal staining scores from baseline. The FL corneal staining scores revealed a statistically significant improvement in both diquafosol groups compared with the placebo group at week 4. In addition, the FL staining score in the 3% diquafosol group was significantly better than in the placebo group at week 6. Ophthalmology 2012 119, 1954-1960DOI: (10.1016/j.ophtha.2012.04.010) Copyright © 2012 American Academy of Ophthalmology Terms and Conditions

Figure 3 The change in the Rose Bengal (RB) corneal and conjunctival staining scores from baseline. The RB corneal and conjunctival staining scores significantly improved in both the 1% and 3% diquafosol treatment groups compared with the placebo group at weeks 4 and 6. Ophthalmology 2012 119, 1954-1960DOI: (10.1016/j.ophtha.2012.04.010) Copyright © 2012 American Academy of Ophthalmology Terms and Conditions

Figure 4 The change in tear break-up times (BUT) from baseline. Tear BUT value showed the most marked improvement in the 3% diquafosol treatment group at weeks 4 and 6. Ophthalmology 2012 119, 1954-1960DOI: (10.1016/j.ophtha.2012.04.010) Copyright © 2012 American Academy of Ophthalmology Terms and Conditions

Figure 5 Change from baseline in dry eye sensation. A significant improvement in dry eye sensation symptom score was shown in both diquafosol groups compared with the placebo group at week 4 and in the 1% diquafosol group at week 6. Ophthalmology 2012 119, 1954-1960DOI: (10.1016/j.ophtha.2012.04.010) Copyright © 2012 American Academy of Ophthalmology Terms and Conditions