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.

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Soft Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 114202
    • Tri-Service General Hospital
  • Taoyuan, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Anterior chamber infection, inflammation, or abnormality.
2. 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.
3. 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).
4. History of herpes simplex keratitis.
5. History of refractive surgery, keratoconus, or irregular cornea.
6. 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).
7. A pathologically dry eye syndrome (Schirmer test < 5 mm).
8. Have participated in any contact lens or contact lens care product clinical trials within the previous 1 month (excluding questionnaire types and specimen collection).
9. Currently pregnant or lactation.
10. Allergy to any contact lens care product ingredient (such as mercury or topical antimicrobial agent).
11. Have experienced discomfort when wearing hydrogel contact lens.
12. Subjects who are judged unsuitable for the study by the investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I; Si-Hy (Samfilcon A)	Device: Soft Contact Lens; Vision Correction
Experimental: Group II; Si-Hy (Otufilcon A)	Device: Soft Contact Lens; Vision Correction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effectiveness of corrected visual acuity	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.	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of corrected visual acuity	Effectiveness of corrected visual acuity at 1 week, 1 month and 2 months. The effectiveness (%) is defined as total number of subjects with vision correction of ≥ 1.0 at a given timepoint / total number of subjects enrolled at a given time × 100 %.	1 week, 1 month and 2 months
Average contact lens corrected visual acuity	The mean, standard deviation, median, maximum, minimum, Q1, Q3 and Inter-Quartile Range (IQR) will be calculated for "Lens corrected visual acuity". Comparisons between the Treatment group and Control group will be made.	1 week, 1 month, 2 months and 3 months
Change in diopter (Spherical and cylindrical power of subjective optometry)	The mean, standard deviation, median, maximum, minimum, Q1, Q3 and Inter-Quartile Range (IQR) will be calculated for "power" (the spherical and cylindrical power). Comparisons between the Treatment group and Control group will be made.	1 week, 1 month, 2 months and 3 months
Change in corneal astigmatism (the vertical and horizontal keratometry meridian, the power and axis of astigmatism)	The mean, standard deviation, median, maximum, minimum, Q1, Q3, and Inter-Quartile Range (IQR) will be calculated for "corneal astigmatism" (the vertical and horizontal curvature, the power and axis of astigmatism). Comparisons between the Treatment group and Control group will be made.	1 week, 1 month, 2 months and 3 months
Lens broken rate	The number and percentage of parameters (total lenses, unbroken lenses, broken lenses) will be calculated and analyzed. Comparisons between the Treatment group and Control group will be made.	1 week, 1 month, 2 months and 3 months
Lens fitting (lens centration, lens movement, coverage, and tightness)	The total number and percentage of parameters (lens centration, lens movement, coverage, tightness) with grading scale evaluated by investigators will be calculated and analyzed. Comparisons between the Treatment group and Control group will be made.	1 week, 1 month, 2 months and 3 months
Subjective acceptance (comfort, vision, lens handling, lens cleaning)	The total number and percentage of parameters (comfort, vision, lens handling, lens cleaning) with a grading scale using questionnaires will be calculated and analyzed. Comparisons between the Treatment group and Control group will be made.	1 week, 1 month, 2 months and 3 months
Lens state (lens front surface wettability, front surface deposits, back surface deposits)	The total number and percentage of parameters (lens front surface wettability, front surface deposits, back surface deposits) with a grading scale evaluated by investigators will be calculated and analyzed. Comparisons between the Treatment group and Control group will be made.	1 week, 1 month, 2 months and 3 months

Collaborators and Investigators

• Sponsor: Yung Sheng Optical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): September 28, 2022
• Study Completion (Actual): September 28, 2022

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Estimated): November 8, 2023

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 0438TC01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No