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

2014-07-24 14:15:02 | BioPortfolio

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.

Description

The objective of the study is to compare the SynergEyes SA Hybrid Contact Lens (Test) to the SynergEyes A Hybrid Contact lens (Control) when used in a daily wear regimen on non-diseased eyes for the correction of myopia (-0.25 to -6.00Diopters) with up to -2.50 Diopters of astigmatism. The population will be randomized into a 2/1 ratio of the Test/Control for 90 days. The study objective is to complete at least 40 subjects in the Test material and 20 subjects in the Control material.

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 powers in a population randomized within investigational sites to produce a 2/1 ratio of Test vs. Control lenses.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Corneal Disease

Intervention

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

Location

Carmel Mountain Vision Care
San Diego
California
United States
92129

Status

Completed

Source

SynergEyes, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:15:02-0400

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