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OpenTrials
Completed

NCT Number: NCT03934788

the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens

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.

Completed

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei TzuChi Hopsital, Buddhist Tzu Chi Medical Foundation, New Taipei City, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject should have normal eye and use no ocular medications
  • VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from -1.00 to -10.00 D myopia, astigmatism =< 2.00 D
  • Willing to comply with all study procedures and be available for the duration of the study.
  • Provide signed and dated informed consent form.

Exclusion criteria

  • Subjects have history of allergies that would contraindicate "normal" contact lens wear.
  • Subjects have other active ocular or systemic disease such as, but not limited to: anterior uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or type II diabetes, slip lamp findings greater than grade I (such as cornea or interstitial edema).
  • Subjects have medications that would contraindicate contact lens wear.
  • The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
  • A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
  • A history of papillary conjunctivitis that has interfered with contact lens wear.
  • Any active participation in another clinical trial within 30 days prior to this study.
  • Have had any cornea surgery.
  • Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 1 month.
  • Monocular or monovision fits
  • Alcoholic or Drug Abused.

Treatment and study plan

oxysoft (olifilcon C)

Device

subjects meet certain criteria will be administered randomly oxysoft on both eye for one month on daily wear single use modality.

Si-Hy (olifilcon B)

Device

subjects meet certain criteria will be administered randomly Si-Hy on both eye for one month on daily wear single use modality.

Primary outcomes

  1. Log MAR visual acuities

    Time frame: 1 month

    The primary efficacy will be Log MAR visual acuities (VA) of 0.1 or better.

Secondary outcomes

  1. slit lamp findings

    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.

Sponsors and collaborators

Lead sponsor

Visco Vision Inc.

Industry

Collaborators

  • Jens Medical Consulting Ltd.

Registry information

Official study title

A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of OxySoft Silicone Hydrogel Soft Contact Lens

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 2, 2019
Registry last updated
May 2, 2019

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.

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