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

Santen

Status: Completed

Conditions: Dry Eye

Treatments: Drug: 0.1% sodium hyaluronate ophthalmic solution.; Drug: diquafosol ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01101984

08901

Details and patient eligibility

About

Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated in comparison with sodium hyaluronate ophthalmic solution.

Enrollment: 400 estimated patients

Sex: All

Ages: 21 to 69 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

DE-089

Experimental group

Description:

DE-089 ophthalmic solution

Treatment:

Drug: diquafosol ophthalmic solution

Drug: 0.1% sodium hyaluronate ophthalmic solution.

HA

Active Comparator group

Description:

0.1% sodium hyaluronate ophthalmic solution

Treatment:

Drug: 0.1% sodium hyaluronate ophthalmic solution.