Hybrid SA RGP Center/S-H Skirt Daily Wear 90 Day Multicenter Study
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|ClinicalTrials.gov Identifier: NCT00804505|
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : December 23, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Corneal Disease Hypersensitivity||Device: SynergEyes Hybrid (petrafocon A hem-larafilcon A) Hybrid Contact Lens Device: SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Contact Lens||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||December 2008|
Test arm daily wear hybrid contact lens.
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.
Control: SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Hybrid Contact Lens
Device: SynergEyes Hybrid (paflufocon D hem-iberfilcon A) Contact Lens
Comparison to test lens: Daily use for minimum 8 hours up to 90 days.
- Comparison of objective findings (slit lamp, lens fitting, deposits, subjective symptoms, adverse events test vs control [ Time Frame: 3 months ]
- Visual acuity comparison test/control. [ Time Frame: 3 mo. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804505
|United States, California|
|Carmel Mountain Vision Care|
|San Diego, California, United States, 92129|
|Silicon Valley Eye Physicians|
|Sunnyvale, California, United States, 94087|
|United States, Massachusetts|
|Casazza Optometric Group|
|Andover, Massachusetts, United States, 01810|
|United States, Michigan|
|Vision Care Associates|
|East Lansing, Michigan, United States, 48823|
|United States, Ohio|
|Western Reserve Vision Care, Inc.|
|Beachwood, Ohio, United States, 44122|
|United States, Rhode Island|
|Dr. Karambelas & Associates|
|Providence, Rhode Island, United States, 02906|
|United States, Tennessee|
|Primary Eyecare Group P.C.|
|Brentwood, Tennessee, United States, 37027|
|United States, Wyoming|
|Snowy Range Vision Center|
|Laramie, Wyoming, United States, 82070|
|Study Director:||William Gleason, OD||Foresight Regulatory Strategies, Inc.|