Performance and Safety of Silicone Hydrogel Soft Contact Lenses

Clinical Evaluation of the Clinical Performance and Safety of a New Monthly Disposable Silicone Hydrogel Soft Contact Lenses

To demonstrate substantial equivalence of the new Silicone Hydrogel Soft Contact Lenses(SHSCL) to the commercially available ACUVUE® VITA™ contact lens

Study Overview

• Status: Unknown
• Conditions: Myopia
• Intervention / Treatment: Device: 41% Silicone Hydrogel Soft Contact Lenses(SHSCL); Other: Contact Lens Care Product; Other: Contact Lens Case; Device: ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens

Detailed Description

This study is a prospective, subject-masked, bilateral, randomized, parallel group dispensing study comparing the SHSCL test lens against the 1-Month ACUVUE® VITA™ (1-MAV) control lenses. Each subject will be randomized to wear either the test or of the control with similar/comparable lens parameters optimized for vision.

Both test and control lens will be used in their daily wear, monthly replacement modality for thirteen (13) weeks. It is anticipated that this study will involve up to 6 scheduled visits.

• Study Type: Interventional
• Enrollment (Anticipated): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Hsinchu, Taiwan, 300
    • Recruiting
    • ApexLens Co., Ltd.
    • Contact: Rex Tsou; Phone Number: 206 886-3-5752910; Email: rex.tsou@apexlens.com
    • Principal Investigator: Yih-Shiou Hwang, M.D.,Ph.D.
    • Principal Investigator: Hsin-Wei Huang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

1. Healthy adult males or females age ≥20-45 years of age;
2. Be a currently adapted soft contact lens wearer (i.e. be wearing lenses at least 1 month prior to enrolment) and the last contact lenses worn more than a week ago;
3. Have a contact lens powers between -2.00D and -6.00D (both inclusive) in both eyes;
4. Astigmatism of 1.00D or less in both eyes;
5. Be able to wear the lens powers available for this study;
6. Be correctable to a visual acuity of 0.8 decimal (+0.10 logMAR) or better in each eye;
7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol;
8. The subject must read and sign the Informed Consent form.

Exclusion Criteria:

A person will be excluded from the study if he/she:

1. Previously unsuccessful with contact lens wear, worn rigid gas permeable contact lenses within past 12 months;
2. Women who are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
3. Any ocular or systemic allergies or diseases that may contraindicate contact lens wear;
4. Any ocular medications use within the last one month;
5. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear;
6. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report;
7. Any current or previous orthokeratology treatment, or planned for orthokeratology treatment during the study;
8. Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.), or planned for ocular and/or refractive surgery during the study
9. History of herpetic keratitis;
10. History of binocular vision abnormality or strabismus, by self-report;
11. Allergic reactions to test lens, control lens or the contact lens solution used in this study;
12. A clinical finding or history of entropion, ectropion, chalazia, recurrent styes, glaucoma, pathologically dry eye, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion, by self-report;
13. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician);
14. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment;
15. Any slit lamp findings which would contraindicate contact lens wear;
16. Any history of a contact lens-related corneal inflammatory event within the past 12 months that may contraindicate contact lens wear; or
17. Clinically significant (grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures;
18. Subjects are considered ineligible for the study as judged by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 41% Silicone hydrogel Soft contact lenses (SHSCL); Healthy adult males or females age ≥20-45 years of age	Device: 41% Silicone Hydrogel Soft Contact Lenses(SHSCL); Silicone Hydrogel; Other: Contact Lens Care Product; Cefatrizine (propylene Glycol), Sodium Citrate (sodium Citrate Tribasic), Sodium Chloride, Sodium Borate (sodium Biboratesodium Tetraborate, Polyquaternium -1, Hydrochloric Acid, Sodium Hydroxide, Water Purified ( Eq to Aqueous Purified Or Purified Water ), Tetronic 1304, Myristamidopropyl Dimethylamine, Nonanoyl Ethylenediaminetriacetic Acid; Other Names: Opti-Free Replenish Multi-purpose Disinfecting Solution; Other: Contact Lens Case; "Alcon" Soft (hydrophilic) Contact Lens Case (Non-Sterile); Other Names: "Alcon" Soft (hydrophilic) Contact Lens Case (Non-Sterile)
ACTIVE_COMPARATOR: ACUVUE® VITA™; Healthy adult males or females age ≥20-45 years of age	Other: Contact Lens Care Product; Cefatrizine (propylene Glycol), Sodium Citrate (sodium Citrate Tribasic), Sodium Chloride, Sodium Borate (sodium Biboratesodium Tetraborate, Polyquaternium -1, Hydrochloric Acid, Sodium Hydroxide, Water Purified ( Eq to Aqueous Purified Or Purified Water ), Tetronic 1304, Myristamidopropyl Dimethylamine, Nonanoyl Ethylenediaminetriacetic Acid; Other Names: Opti-Free Replenish Multi-purpose Disinfecting Solution; Other: Contact Lens Case; "Alcon" Soft (hydrophilic) Contact Lens Case (Non-Sterile); Other Names: "Alcon" Soft (hydrophilic) Contact Lens Case (Non-Sterile); Device: ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens; Senofilcon C (USFDA Device License #K160212)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best-corrected contact lens visual acuity	The primary efficacy endpoint in this evaluation is the percentage of subjects with best-corrected contact lens visual acuity of 0.8 decimal (+0.10 logMAR) and 1.0 decimal (0.00 logMAR) or better. The Snellen chart will be used for visual acuity testing.	13 weeks
Permanent loss of visual acuity	The primary safety endpoint in this evaluation is the percentage of subjects with permanent loss of two or more lines of visual acuity.	13 weeks
Serious adverse reactions	The primary safety endpoint in this evaluation is the rate of serious adverse reactions related to visual acuity loss as well as accompanying slit-lamp findings and other associated observations.	13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens comfort	The secondary efficacy endpoint is the assessment of lens comfort over time with the lens for the recommended wearing time. This will be measured using Study Diary. Subject will be given a Study Diary to be completed at home, to reflect their lens wear experience at the time of rating. Subject will be given careful explanation of how and when to complete them. Comfort after insertion (i.e. after lens settling), after 4 hours, and just before lens removal (0-10 scale)(10 = cannot be felt, 0 = painful)	13 weeks
Symptoms of dryness	The secondary efficacy endpoint is the assessment of dryness symptoms with the lens for the recommended wearing time. This will be measured using Study Diary. Subject will be given a Study Diary to be completed at home, to reflect their lens wear experience at the time of rating. Subject will be given careful explanation of how and when to complete them. Dryness after insertion (i.e. after lens settling), after 4 hours, and just before lens removal (0-10 scale)(10 = cannot be felt, 0 = painful)	13 weeks
Slit lamp findings	The secondary efficacy endpoint is the assessment of the rate of any Slit Lamp Findings > Grade 2. The subject will be instructed to take off the study lenses before the slit-lamp biomicroscopy assessment. Slit-lamp biomicroscopy will be assessed according to the approved study biomicroscopy CRF. ISO 11980:2012 Annex B will be used to grade the Slit-lamp findings.	13 weeks
Subject reported ocular complaints	Subjects will be asked to assess ocular complaints by using Study Diary.	13 weeks

Collaborators and Investigators

• Sponsor: ApexLens Co., Ltd.
• Collaborators: Chang Gung Memorial Hospital; Taipei Medical University WanFang Hospital
• Investigators: Principal Investigator: Yih-Shiou Hwang, M.D.,Ph.D., Chang Gung Memorial Hospital; Principal Investigator: Hsin-Wei Huang, M.D., Taipei Medical University - Municipal Wan Fang Hospital

Publications and helpful links

General Publications

• Dumbleton KA, Woods CA, Jones LW, Fonn D. The relationship between compliance with lens replacement and contact lens-related problems in silicone hydrogel wearers. Cont Lens Anterior Eye. 2011 Oct;34(5):216-22. doi: 10.1016/j.clae.2011.03.001. Epub 2011 Apr 13.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2020
• Primary Completion (ANTICIPATED): May 30, 2021
• Study Completion (ANTICIPATED): May 30, 2021

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (ACTUAL): January 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Contact lens; Myopia control; Nearsightedness; Eye wear
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: ApexLens-201901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No