Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry Eye

Double-Masked, Randomized, Placebo-Controlled Study of Efficacy Parameter Following Administration of INS365 Ophthalmic Solution or Placebo in a Controlled Adverse Environment (CAE) Chamber in Subjects With Non-Sjogren's Associated Dry Eye

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00037661

Enrollment

222

Registered

2002-05-20

Start date

2002-04-30

Completion date

2003-03-31

Last updated

2015-10-02

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

Conditions

Keratoconjunctivitis Sicca

Keywords

dry eye

Brief summary

Comparative efficacy trial of INS365 Ophthalmic Solution and placebo in patients with dry eye.

Interventions

DRUGINS365 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

* have Non-Sjogren's associated dry eye disease with symptoms lasting greater than 6 months * had intermittent or regular artificial tear use within past 3 months

Exclusion criteria

* had LASIK surgery * had punctal occlusion or cauterization within last 3 months

Outcome results

None listed

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