Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

Phase 3 Completed 500 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic Solution with placebo when applied topically in subjects with dry eye disease.

Timeline

Start: 2001-03
Primary completion: 2001-12
Completion: 2001-12

Outcome

Met primary endpoint

paper Subjects treated with 2% diquafosol had significantly lower corneal staining scores compared with placebo at the 6-week, primary efficacy time point (P<0.001) PMID 15502479 ↗

Publications

Results Tauber J, Davitt WF, Bokosky JE, Nichols KK, Yerxa BR, Schaberg AE, LaVange LM, Mills-Wilson MC, Kellerman DJ. Double-masked, placebo-controlled safety and efficacy trial of diquafosol tetrasodium (INS365) ophthalmic solution for the treatment of dry eye. Cornea. 2004 Nov;23(8):784-92. doi: 10.1097/01.ico.0000133993.14768.a9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Diquafosol tetrasodium	Oligonucleotide (other)	1 %	Topical
Subject	Diquafosol tetrasodium	Oligonucleotide (other)	2 %	Topical