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Hybrid SA RGP Center/S-H Skirt Daily Wear 90 Day Multicenter Study

NCT00804505 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2009-12-23

No results posted yet for this study

Summary

The purpose of the study is to demonstrate that the SynergEyes SA Hybrid Contact Lens clinical performance is substantially equivalent to that of the SynergEyes A Hybrid Lens when studied:

* within the corresponding range of lens powers
* in a population randomized within multiple investigational sites
* with a study ration of 2/1 test vs control lenses
* for a duration of 90 days.

Conditions

Interventions

DEVICE

SynergEyes Hybrid (petrafocon A hem-larafilcon A) Hybrid Contact Lens

Comparison to control hybrid lens with similar 'dose'minimum 8 hours daily use for up to 90 days.

DEVICE

SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Contact Lens

Comparison to test lens: Daily use for minimum 8 hours up to 90 days.

Sponsors & Collaborators

  • SynergEyes, Inc.

    lead INDUSTRY

Principal Investigators

  • William Gleason, OD · Foresight Regulatory Strategies, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2008-11-30
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00804505 on ClinicalTrials.gov