NCT00739349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

June 6, 2016

Status Verified

June 1, 2015

Enrollment Period

5 months

First QC Date

August 20, 2008

Last Update Submit

May 26, 2016

Conditions

Dry Eye

Keywords

Dry EyeCyclosporine

Outcome Measures

Primary Outcomes (1)

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

    Approximately 13 weeks

Study Arms (3)

1

EXPERIMENTAL

Cyclosporine 0.05%

Drug: NOVA22007 ''Cyclosporine''

2

EXPERIMENTAL

Cyclosporine 0.1%

Drug: NOVA22007 ''Cyclosporine''

3

PLACEBO COMPARATOR

vehicle/placebo

Drug: vehicle/placebo

Interventions

NOVA22007 ''Cyclosporine''DRUG

Cyclosporine 0.05% Ophthalmic Cationic Emulsions

1
vehicle/placeboDRUG

vehicle/placebo

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Maine Eye Care, PA

Lewiston, Maine, 04240, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 21, 2008

Study Start

August 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

June 6, 2016

Record last verified: 2015-06

Locations

US(1)