Skip to main content
OpenTrials
Completed

NCT Number: NCT00789529

Objective Testing of Tear Film Stability

The purpose of this study is to evaluate the in-vivo wettability of soft contact lenses when cared with two different multi-purpose solutions over a two week wearing period.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MVA/IVR

New York, 10022, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The subject must be at least 18 years of age and no more than 80 years of age.
  • The subject must have a best corrected visual acuity of 20/30 or better for each eye.
  • The subject must habitually wear contact lenses.
  • The subject must have had an eye exam within the last 12 months. The exam data must be available to the investigators prior to the first visit.
  • The subject must have normal eyes, no use of ocular medications, no ocular infection of any type, and no ocular inflammation.
  • The subject must read understand and sign the Statement of Informed Consent.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion criteria

  • Ocular or systemic allergies or disease that might interfere with contact lens wear.
  • Systemic disease, autoimmune disease or use of medication which might interfere with contact lens wear.
  • Clinically significant (FDA Scale grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormalities of the cornea which would contraindicate contact lens wear.
  • Clinically significant (FDA Scale grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  • Any ocular infection.
  • Pregnancy or lactation.
  • Diabetes
  • Infectious diseases (e.g. hepatitis, tuberculosis)
  • Contagious immunosuppressive diseases (e.g. HIV)

Treatment and study plan

OPTI-FREE® RepleniSH® MPDS

Device

soft contact lens disinfecting solution

ReNu MultiPlus®

Device

soft contact lens disinfecting solution

Primary outcomes

  1. Objective, In-vivo Soft Contact Lens Wettability Index

    Time frame: 2 weeks

    The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack-Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens.

Secondary outcomes

  1. Subject Questionnaire Response

    Time frame: 2 weeks

    Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale.

    0=Very poor 50 = Excellent

Sponsors and collaborators

Lead sponsor

Manhattan Vision Associates

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 13, 2008
Registry last updated
May 31, 2013

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.

Published trials that share one or more normalized conditions with this study.