NCT00804505

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

A 90 Day Multi-Center, Randomized, Parallel Group Daily Wear Investigation of a New Hybrid Lens SynergEyes SA Manufactured With a Rigid Gas Permeable Center (Petrafocon A) and a Silicone Hydrogel Skirt (Larafilcon A) Compared to SynergEyes A (Paflufocon D Hem-iberfilcon A)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: SynergEyes, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Corneal Disease
• Hypersensitivity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2008-12-09
• Last updated: 2009-12-23

Locations

8 sites across 1 country: United States