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CompletedNCT00739349Updated Jun 6, 2016

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

A Phase 2 interventional study of NOVA22007 ''Cyclosporine'' and NOVA22007 ''Cyclosporine'' in Dry Eye, sponsored by Santen SAS. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-06.

Sponsored by Santen SAS (part of Santen Pharmaceutical Co., Ltd.) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dry Eye

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Keywords

  • Dry Eye
  • Cyclosporine
03

In context

Dry Eye Syndromes

1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.

This study's enrollment of 132 is above the median of 60 across 1,103 interventional studies indexed under Dry Eye Syndromes.

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Lead sponsor

Santen SAS is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

First submitted before Santen Inc. became part of Santen Pharmaceutical Co., Ltd..

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
132 participants (actual)

Study arms

  • Experimental
    1

    Cyclosporine 0.05%

    Drug: NOVA22007 ''Cyclosporine''

  • Experimental
    2

    Cyclosporine 0.1%

    Drug: NOVA22007 ''Cyclosporine''

  • Placebo comparator
    3

    vehicle/placebo

    Drug: vehicle/placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Assess the safety and efficacy of two doses of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Emulsions

    Time frame: Approximately 13 weeks

07

Study locations

1 site
  • Central Maine Eye Care, PA
    Lewiston, Maine 04240, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00739349
Lead sponsor
Santen SAS
Responsible party
Sponsor
First posted
Aug 21, 2008
Start date
Aug 2008
Primary completion
Jan 2009
Completion
Jan 2009
Last update
Jun 6, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: NOVA22007

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