Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Subjects With Dry Eye Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00403715

Enrollment

500

Registered

2006-11-27

Start date

2001-02-28

Completion date

2002-09-30

Last updated

2016-11-29

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 compare the effectiveness and safety of INS365 Ophthalmic Solution with Placebo when applied topically in subjects with dry eye disease.

Interventions

DRUGdiquafosol tetrasodium (INS365) Ophthalmic Solution

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 * at least mild severity in 2 of the 4 dry eye symptoms * unanesthetized Schirmer score of less than or equal to 7mm * corneal fluorescein staining of greater than or equal to 4 (out of 15)

Exclusion criteria

* nasally stimulated Schirmer score of less than 3mm in subjects with an initial Schirmer score of 0mm * ongoing contact lens wear * current topical ophthalmic medication use

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

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