Clinical trial NCT04226560: Performance and Safety of Silicone Hydrogel Soft Contact Lenses
Official title: Clinical Evaluation of the Clinical Performance and Safety of a New Monthly Disposable Silicone Hydrogel Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Keywords: Nearsightedness
Eye wear
Myopia control
Contact lens
Lead sponsor: ApexLens Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chang Gung Memorial Hospital
name: Taipei Medical University WanFang Hospital
First posted: 2020-01-13
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate substantial equivalence of the new Silicone Hydrogel Soft Contact Lenses(SHSCL) to the commercially available ACUVUE® VITA™ 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Best-corrected contact lens visual acuity
timeFrame: 13 weeks
measure: Permanent loss of visual acuity
timeFrame: 13 weeks
measure: Serious adverse reactions
timeFrame: 13 weeks
Secondary outcomes:
measure: Lens comfort
timeFrame: 13 weeks
measure: Symptoms of dryness
timeFrame: 13 weeks
measure: Slit lamp findings
timeFrame: 13 weeks
measure: Subject reported ocular complaints
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: ApexLens Co., Ltd.
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yih-Shiou Hwang, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Medical University - Municipal Wan Fang Hospital
name: Hsin-Wei Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.