Objective Testing of Tear Film Stability

NCT00789529 | Completed Results

• 1 other identifier: CS-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Contact Lens Solutions

Keywords

Contact lenses, wettability, Contact Lens Disinfectant Solutions, pre-lens tear film

Outcome Measures

Primary Outcomes (1)

• Objective, In-vivo Soft Contact Lens Wettability Index

  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.

  2 weeks

Secondary Outcomes (1)

• Subject Questionnaire Response

  2 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Opti-Free® RepleniSH® MPDS

Device: Opti-Free® RepleniSH® MPDS

2

ACTIVE COMPARATOR

Renu MultiPlus®

Device: ReNu MultiPlus®

Interventions

Opti-Free® RepleniSH® MPDS DEVICE

soft contact lens disinfecting solution

1

ReNu MultiPlus® DEVICE

soft contact lens disinfecting solution

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Manhattan Vision Associates: lead
• Alcon Research: collaborator

Study Sites (1)

MVA/IVR

New York, New York, 10022, United States

Location

Results Point of Contact

• Title: Dr. George Zikos
• Organization: Manhattan Vision Associates / Institute for Vision Research

gzikos@mvaivr.com

2126884277

Study Officials

• George Zikos, OS, MS

  MVA/IVR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2008
• First Posted: November 13, 2008
• Study Start: September 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 31, 2013
• Results First Posted: May 31, 2013

Record last verified: 2013-04

Locations

US (1)