NCT00477763

Brief Summary

To compare the performance of Oasys to Extreme H20 xtra 59 in dry eye contact lens pts who receive Restasis in 1 eye and vehicle (Endura) in the other eye.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2007

Shorter than P25 for phase_4

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

May 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

February 18, 2008

Status Verified

February 1, 2008

Enrollment Period

9 months

First QC Date

May 21, 2007

Last Update Submit

February 13, 2008

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • comparing performance of contact lens

    10 months

Secondary Outcomes (1)

  • Dry eye

    10 months

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Restasis, Refresh Endura

2

PLACEBO COMPARATOR
Drug: Restasis, Refresh Endura

Interventions

Restasis, Refresh EnduraDRUG

1. Restasis 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening 2. Refresh Endura 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening

12

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female at least 19 years of age
  • Contact Lens Wearers
  • Patients with mild to moderate symptoms of dry eye

You may not qualify if:

  • male or female younger than 19 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hazleton Eye Specialists

Hazleton, Pennsylvania, 18202, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Thomas Kislan, OD

    Hazleton Eye Specialists

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 24, 2007

Study Start

May 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

February 18, 2008

Record last verified: 2008-02

Locations

US(1)