Expired Study
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New York, New York 10021


Purpose:

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.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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.


Study is Available At:


Original ID:

0710009485


NCT ID:

NCT00570843


Secondary ID:


Study Acronym:


Brief Title:

Masked Comparison of a New PEG Based Artificial Tear and Optive for Comfort, Vision & Wear Time in Patients Wearing Contact Lenses


Official Title:

Phase 4 Masked Comparison of a New PEG Based Artificial Tear and Optive for Comfort, Vision & Wear Time in Patients Wearing Contact Lenses


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bp Consulting, Inc


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Chris Starr, MD
Principal Investigator
The New York Presbyterian Hospital Weill Cornell Medical College

Study Dates

Start Date:March 2008
Completion Date:February 2010
Completion Type:Actual
Primary Completion Date:February 2010
Primary Completion Type:Actual
Verification Date:February 2010
Last Changed Date:February 19, 2010
First Received Date:December 7, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:Comfort
Time Frame:1 month
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:vision and wear time
Time Frame:1 month
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:New PEG based artificial tear
Description: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)
Arm Name:1.
Intervention Type:Drug
Name:Optive
Description: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)
Arm Name:2.

Study Arms

Study Arm Type:Active Comparator
Arm Name:1.
Study Arm Type:Placebo Comparator
Arm Name:2.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Bp Consulting, Inc

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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