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Clinical Biocompatibility Evaluation of Contact Lens Coatings

NCT03034928 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2020-02-18

Study results available
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Summary

The primary objective is to evaluate corneal staining observed after 2 hours of wear with contact lenses with investigational coating against PureVision™ lenses, all pre-cycled with OPTI-FREE® RepleniSH® multi-purpose disinfection solution.

Conditions

  • Refractive Errors
  • Ametropia

Interventions

DEVICE

Contact lens with investigational coating 1

Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)

DEVICE

Balafilcon A contact lens

Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS

DEVICE

OPTI-FREE® RepleniSH® MPDS

Multipurpose contact lens solution

DEVICE

Contact lens with investigational coating 2

Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Sr. Clinical Manager, Trial Management Operations · Alcon, A Novartis Division

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-14
Primary Completion
2017-03-14
Completion
2017-03-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03034928 on ClinicalTrials.gov