Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye

Summary

To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in fluorescein staining score, and is superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group comparison study. Safety profile will likewise be compared.

Timeline

Start

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Primary completion

2008-02

Completion

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Outcome

Met primary endpoint

paper After 4 weeks, the intergroup difference in the mean change from baseline in fluorescein staining score was -0.03; this verified the non-inferiority of diquafosol. PMID 22914501 ↗

paper The mean change from baseline in rose bengal staining score was significantly lower in the diquafosol group (p=0.010), thus verifying its superiority. PMID 22914501 ↗

Publications

• Takamura E, Tsubota K, Watanabe H, Ohashi Y; Diquafosol Ophthalmic Solution Phase 3 Study Group. A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients. Br J Ophthalmol. 2012 Oct;96(10):1310-5. doi: 10.1136/bjophthalmol-2011-301448. Epub 2012 Aug 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Diquafosol tetrasodium	Oligonucleotide (other)	3 %	Topical
Comparator	Sodium Hyaluronate	Other / unclassified	0.1 %	Topical

Indications