A Prospective, Randomized, Double-blind, Parallel, Active-controlled Clinical Study of Silicone Hydrogel Monthly Soft Contact Lens for the Safety and Effectiveness in Visual Correction.

Yung Sheng Optical Co., Ltd.2 sites in 1 country144 target enrollmentFebruary 1, 2021

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Yung Sheng Optical Co., Ltd.
Enrollment: 144
Locations: 2
Primary Endpoint: The effectiveness of corrected visual acuity
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This was a prospective, randomized, double-blind, parallel, active-controlled clinical study to assess the safety and efficacy of Silicone Hydrogel Contact Lens for vision correction.

Registry

clinicaltrials.gov

Start Date

February 1, 2021

End Date

September 28, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yung Sheng Optical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•20 years old and above.
•Subjects with normal eyes who are not using any ocular medications (excluding ocular lubricants and artificial tears).
•Best spectacle corrected visual acuity greater than or equal to 1.0 for both eyes.
•With +6.00D \~ -12.00 D spherical power, and ≦1.00 D astigmatism (based on subjective optometry measurements).
•Have worn soft contact lens for at least 1 month prior to the study.
•Willing to comply with the required wearing time and use specified contact lens care product.
•Agree to comply with all study procedures and signed the informed consent form before enrollment.

Exclusion Criteria

•Anterior chamber infection, inflammation, or abnormality.
•Any active ocular disease that would affect contact lens wear or vision (such as acute and subacute inflammation of the anterior chamber of the eye, eye infection, uveitis, serious palpebral abnormality, corneal hypoesthesia, corneal epithelium abrasion, dry eye and tear duct defection, ocular allergies, highly suspected glaucoma) upon evaluation by the investigators or slit lamp findings.
•Currently using systemic or ocular medications that would contraindicate with contact lens wear (such as, glaucoma eye drops, steroid anti-inflammatory drops, eye ointments, eye gels and other eye medicines).
•History of herpes simplex keratitis.
•History of refractive surgery, keratoconus, or irregular cornea.
•Slit lamp findings that are not suitable for inclusion (Details of the grading standards for each eye condition are specified in CIP section 5.7.5 from page 38 to 43).
•A pathologically dry eye syndrome (Schirmer test \< 5 mm).
•Have participated in any contact lens or contact lens care product clinical trials within the previous 1 month (excluding questionnaire types and specimen collection).
•Currently pregnant or lactation.
•Allergy to any contact lens care product ingredient (such as mercury or topical antimicrobial agent).

Outcomes

Primary Outcomes

The effectiveness of corrected visual acuity

Time Frame: 3 Months

The effectiveness of corrected visual acuity at 3-month. Effectiveness is defined as visual acuities of both eyes correctable to ≥1.0 with contact lens. Effectiveness formula (%): total number of subjects with vision correction of ≥ 1.0 at a given timepoint / total number of subjects enrolled at a given time × 100 %. Definition of total number of subjects enrolled at a given time: the total number of subjects conforming to the PPS criteria and having worn lenses for 3 months.

Secondary Outcomes

Change in diopter (Spherical and cylindrical power of subjective optometry)(1 week, 1 month, 2 months and 3 months)
Average contact lens corrected visual acuity(1 week, 1 month, 2 months and 3 months)
Lens fitting (lens centration, lens movement, coverage, and tightness)(1 week, 1 month, 2 months and 3 months)
Effectiveness of corrected visual acuity(1 week, 1 month and 2 months)
Change in corneal astigmatism (the vertical and horizontal keratometry meridian, the power and axis of astigmatism)(1 week, 1 month, 2 months and 3 months)
Lens broken rate(1 week, 1 month, 2 months and 3 months)
Lens state (lens front surface wettability, front surface deposits, back surface deposits)(1 week, 1 month, 2 months and 3 months)
Subjective acceptance (comfort, vision, lens handling, lens cleaning)(1 week, 1 month, 2 months and 3 months)