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OpenTrials
Completed

NCT Number: NCT00570843

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

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.

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Key information

Conditions

Comfort, Vision and Wear Time

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The New York Presbyterian Hospital-Weill Cornell Medical College

New York, 10021, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

New PEG based artificial tear

Drug

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)

Optive

Drug

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)

Primary outcomes

  1. Comfort

    Time frame: 1 month

Secondary outcomes

  1. vision and wear time

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Bp Consulting, Inc

Network

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 11, 2007
Registry last updated
Feb 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.