Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02676258|
Recruitment Status : Completed
First Posted : February 8, 2016
Last Update Posted : July 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Myopia||Device: Si-Hy (olifilcon B) Device: Vistakon (narafilcon A)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of Si-Hy Silicone Hydrogel Soft Contact Lens|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Experimental: Si-Hy soft contact lens
olifilon B daily disposable soft contact lens
Device: Si-Hy (olifilcon B)
Wear Si-Hy silicone hydrgel soft contact lens for 3 months
Active Comparator: Vistakon soft contact lens
narafilcon A daily disposable soft contact lens
Device: Vistakon (narafilcon A)
Wear Vistakon soft contact lens for 3 months
- Visual Acuity [ Time Frame: over all follow-up visits for 3 month study period ]logMAR visual acuity (VA) over all visits.
- Any Slit Lamp Finding > Grade 2 [ Time Frame: over all follow-up visits for the 3 month study period ]All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=sever findings.
- Subjective Response to Comfort, symptoms and complaints [ Time Frame: over all follow-up visits for the 3 month study period ]subjective ratings of comfort, symptom and complaints using a scale of 0=severe stinging/Burning to 10=No stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.
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): NCT02676258
|MayKay Memorial Hospital|
|Principal Investigator:||Huey Chuan Cheng, MD MS||Mackay Memorial Hospital|