A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution

A Double-Masked, Randomized, Placebo-Controlled, Rising-Dose Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution in Patients With Mild to Moderate Dry Eye Disease.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00680108

Enrollment

Registered

2008-05-19

Start date

1999-09-30

Completion date

2000-05-31

Last updated

2015-08-27

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 study is to evaluate the safety and tolerability of INS365 Ophthalmic Solution when applied topically as eyedrops in patients with mild to moderate dry eye disease.

Interventions

DRUGdiquafosol tetrasodium (INS365) ophthalmic solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Inclusion criteria

* Best corrected visual acuity 20/40 in each eye * 2 out 5 specified symptoms * Corneal fluorescein staining score greater than or equal to 3 out of 15

Exclusion criteria

* Unable to stop concomitant medications * Have had intraocular surgery in previous 90 days * Have excluded systemic or ocular disease * Wear contact lenses and are not willing to remove them * Have intraocular pressure greater than 22 mg Hg

Design outcomes

Primary

Measure	Time frame
Evaluation of adverse events	—
Ocular symptomatology	—
Visual acuity	—
Biomicroscopy	—
Ophthalmoscopy	—

Secondary

Measure	Time frame
Unanesthetized Schirmer test	—

Outcome results

None listed

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