Study of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye Disease

A Multi-Center, Parallel Group, Double-Masked, Randomized, Placebo-Controlled Study of Multiple Ocular Instillations of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00403975

Enrollment

640

Registered

2006-11-27

Start date

2004-06-30

Completion date

2004-11-30

Last updated

2016-02-22

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

Conditions

Dry Eye Disease

Brief summary

The purpose of this trial is to assess the effectiveness and safety of 2% diquafosol tetrasodium ophthalmic solution versus placebo following 6 weeks of treatment in subjects with mild to moderate dry eye disease.

Interventions

DRUGdiquafosol tetrasodium ophthalmic solution, 2%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* best corrected visual acuity in both eyes of at least +0.7 * six-month documented history of dry eye disease * as least mild severity in 1 of the 5 dry eye symptoms * corneal fluorescein staining of greater than or equal to 3 and less than or equal to 6 (out of 15)

Exclusion criteria

* permanent conjunctival goblet cell loss or scarring conditions * ongoing contact lens wear * current topical ophthalmic medication use

Design outcomes

Primary

Measure	Time frame
Change in dry eye testing measures	—

Secondary

Measure	Time frame
Change in dry eye testing measures and symptoms	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026