Performance and Safety of Silicone Hydrogel Soft Contact Lenses
NCT ID: NCT04226560
Last Updated: 2021-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
65 participants
INTERVENTIONAL
2020-04-20
2021-05-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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41% Silicone hydrogel Soft contact lenses (SHSCL)
Healthy adult males or females age ≥20-45 years of age
41% Silicone Hydrogel Soft Contact Lenses(SHSCL)
Silicone Hydrogel
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
Contact Lens Case
"Alcon" Soft (hydrophilic) Contact Lens Case (Non-Sterile)
ACUVUE® VITA™
Healthy adult males or females age ≥20-45 years of age
ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens
Senofilcon C (USFDA Device License #K160212)
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
Contact Lens Case
"Alcon" Soft (hydrophilic) Contact Lens Case (Non-Sterile)
Interventions
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41% Silicone Hydrogel Soft Contact Lenses(SHSCL)
Silicone Hydrogel
ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens
Senofilcon C (USFDA Device License #K160212)
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
Contact Lens Case
"Alcon" Soft (hydrophilic) Contact Lens Case (Non-Sterile)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
45 Years
ALL
Yes
Sponsors
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Chang Gung Memorial Hospital
OTHER
Taipei Medical University WanFang Hospital
OTHER
ApexLens Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yih-Shiou Hwang, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Hsin-Wei Huang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Taipei Medical University - Municipal Wan Fang Hospital
Locations
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ApexLens Co., Ltd.
Hsinchu, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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ApexLens-201901
Identifier Type: -
Identifier Source: org_study_id
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