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

Santen

Status and phase: Completed; Phase 3

Conditions: Dry Eye

Treatments: Drug: 0.1% sodium hyaluronate ophthalmic solution; Drug: 3% DE-089 ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01240382

00890602

Details and patient eligibility

About

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.

Enrollment: 332 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

332 participants in 2 patient groups

3% DE-089

Experimental group

Treatment:

Drug: 3% DE-089 ophthalmic solution

0.1% HA

Active Comparator group

Treatment:

Drug: 0.1% sodium hyaluronate ophthalmic solution