Hybrid SA RGP Center/S-H Skirt Daily Wear 90 Day Multicenter 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.
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)
Links
- Source: http://clinicaltrials.gov/show/NCT00804505
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Two-hybrid System Techniques
Screening techniques first developed in yeast to identify genes encoding interacting proteins. Variations are used to evaluate interplay between proteins and other molecules. Two-hybrid techniques refer to analysis for protein-protein interactions, one-hybrid for DNA-protein interactions, three-hybrid interactions for RNA-protein interactions or ligand-based interactions. Reverse n-hybrid techniques refer to analysis for mutations or other small molecules that dissociate known interactions.
Hybrid Vigor
The adaptive superiority of the heterozygous GENOTYPE with respect to one or more characters in comparison with the corresponding HOMOZYGOTE.
Hybridization, Genetic
The genetic process of crossbreeding between genetically dissimilar parents to produce a hybrid.
Computers, Hybrid
Computers that combine the functions of analog and digital computers. (Sippl, Computer Dictionary, 4th ed)
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