NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye

A Phase II, Multi-Center, Double-Masked, Randomized Study of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Cationic Emulsions Compared to Vehicle for the Treatment of the Signs and Symptoms of Dry Eye

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00739349

Enrollment

132

Registered

2008-08-21

Start date

2008-08-31

Completion date

2009-01-31

Last updated

2016-06-06

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

Conditions

Dry Eye

Keywords

Dry Eye, Cyclosporine

Brief summary

Study is to assess the safety and efficacy of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Cationic Emulsions QD compared to vehicle for the treatment of the signs and symptoms of dry eye after a 3 month treatment period.

Interventions

DRUGNOVA22007 ''Cyclosporine''

Cyclosporine 0.05% Ophthalmic Cationic Emulsions

DRUGvehicle/placebo

vehicle/placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male and female 18 years and older * Diagnosis of dry eye in both eyes

Exclusion criteria

* Contraindications to the use of the study medications * Known allergy or sensitivity to the study medications or their components * Female currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test * Have participated in an investigational drug or device study within 30 days of Visit 1

Design outcomes

Primary

Measure	Time frame
Assess the safety and efficacy of two doses of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Emulsions	Approximately 13 weeks

Countries

United States

Outcome results

None listed

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