NCT00570843

Brief Summary

The objective of this study is to evaluate the effect of a new PEG based artificial tear as compared to Optive on comfort, wear time, and vision in patients wearing contact lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2008

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 22, 2010

Status Verified

February 1, 2010

Enrollment Period

1.9 years

First QC Date

December 7, 2007

Last Update Submit

February 19, 2010

Conditions

Comfort, Vision and Wear Time

Outcome Measures

Primary Outcomes (1)

  • Comfort

    1 month

Secondary Outcomes (1)

  • vision and wear time

    1 month

Study Arms (2)

1.

ACTIVE COMPARATOR
Drug: New PEG based artificial tear

2.

PLACEBO COMPARATOR
Drug: Optive

Interventions

New PEG based artificial tearDRUG

1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed)

1.
OptiveDRUG

1, 2, (in the eye) Instill one drop in the left eye or right eye four times daily (can be used more frequently if needed)

2.

Eligibility Criteria

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

You may qualify if:

  • Use of soft contact lenses (e.g. silicone hydrogel lenses, daily disposables etc.) and multipurpose solution for cleaning, including enzyme-based cleaners (ClearCare etc.)
  • Able to wear contact lenses for approximately 10-12 hours/day
  • Willingness to complete entire length of trial and comply with subjective questionnaire.

You may not qualify if:

  • Patients taking topical cyclosporine (Restasis)
  • Patients currently using Optive for dryness relief.
  • Patients wearing hard or rigid gas permeable lenses
  • Patients with uncontrolled systemic disease which may confound the results of the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The New York Presbyterian Hospital-Weill Cornell Medical College

New York, New York, 10021, United States

Location

Study Officials

  • Chris Starr, MD

    The New York Presbyterian Hospital Weill Cornell Medical College

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 7, 2007

First Posted

December 11, 2007

Study Start

March 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

February 22, 2010

Record last verified: 2010-02

Locations

US(1)