oxysoft (olifilcon C)
Devicesubjects meet certain criteria will be administered randomly oxysoft on both eye for one month on daily wear single use modality.
NCT Number: NCT03934788
The objective of this study is to demonstrate that the OxySoft silicone hydrogel soft contact lens could be prescribed as a supportive care for myopes.
Looking for future studies?
Notify Me20 year and older
All sexes
Interventional
Not applicable
Taipei TzuChi Hopsital, Buddhist Tzu Chi Medical Foundation, New Taipei City, Taiwan
This is a double blind randomized control study to evaluate a daily disposable contact lens. It is planned to have 30 evaluable subjects at least divided evenly among 3 independent PIs. Each PI will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. The study lens will be dispensed randomly to subjects who have normal ocular health and conform to a set of criteria. It is necessary to wear the lens 8 hours a day and 5 days a week at least and follow up for one month (30 days). Data will be collected at baseline, 1 week, 2 week and 4 week of daily disposable modality including Adverse Reactions, Slit-lamp findings and Symptoms, Problems, and Complaints, vision acuity, keratometry change and reason for discontinuation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
subjects meet certain criteria will be administered randomly oxysoft on both eye for one month on daily wear single use modality.
subjects meet certain criteria will be administered randomly Si-Hy on both eye for one month on daily wear single use modality.
Time frame: 1 month
The primary efficacy will be Log MAR visual acuities (VA) of 0.1 or better.
Time frame: 1 month
Any slit lamp findings > grade 2 [ Time Frame: over all follow-up visits for the 1 month ] slit lamp findings on all dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=sever findings.
Visco Vision Inc.
Industry
A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of OxySoft Silicone Hydrogel Soft Contact Lens
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03334253
Eye Diseases, Myopia
Birmingham, Alabama, United States
View Trial DetailsNCT07087665
Eye Diseases, Myopia
Saint Louis Park, Minnesota, United States
View Trial DetailsNCT06700460
Eye Diseases, Myopia
Omaha, Nebraska, United States
View Trial DetailsNCT00320593
Eye Diseases, Myopia
Birmingham, Alabama, United States
View Trial Details