A phase III study of 3 % DE-089C ophthalmic solution in subject with Dry eye.

A phase III, randomized, double masked, placebo controlled, parallel, multicenter study: To evaluate efficacy and safety of 3 % DE-089C ophthalmic solution in subject with Dry eye.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225082

Enrollment

300

Registered

2020-02-20

Start date

2020-02-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dry eye

Interventions

investigational material(s) Generic name etc : Diquafosol Sodium INN of investigational material : diquafosol Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for In

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Outpatients - Both eyes diagnosed as having dry eye

Exclusion criteria

Exclusion criteria: - Ocular condition which affects ocular surface expect dry eye - Ocular disease which needs treatment expect dry eye - Eyelid closure failure (e.g. blepharospasm, lagophthalmos) - Anyone otherwise considered unsuitable for the study by the investigators

Design outcomes

Primary

Measure	Time frame
efficacy Change CFS score from Week 0 at Week 4	—

Secondary

Measure	Time frame
efficacy Change from Week 0 for ocular symptom(Dryness) score of DEQS at Week 4	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026