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

Santen

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Drug: DE-089 ophthalmic solution; Drug: Placebo ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01189032

00890404

Details and patient eligibility

About

Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in patients with dry eye, using a multicenter, randomized, double-blind, parallel group comparison study, and the optimal concentration is determined.

Enrollment: 320 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Those who show:

  • Keratoconjunctival disorder confirmed with vital dye staining
  • Abnormal Schirmer score results

Exclusion criteria

• Eye disease that needs therapy other than that for dry eye
• Those who need to wear contact lenses during the clinical study

Trial design

320 participants in 3 patient groups, including a placebo group

High concentration

Experimental group

Treatment:

Drug: DE-089 ophthalmic solution

Drug: DE-089 ophthalmic solution

Low concentration

Experimental group

Treatment:

Drug: DE-089 ophthalmic solution

Drug: DE-089 ophthalmic solution

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo ophthalmic solution