An interventional study of 41% Silicone Hydrogel Soft Contact Lenses(SHSCL) and ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens in Myopia, sponsored by ApexLens Co., Ltd.. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-24.
Sponsored by ApexLens Co., Ltd. · Not applicable, Interventional, and Treatment
To demonstrate substantial equivalence of the new Silicone Hydrogel Soft Contact Lenses(SHSCL) to the commercially available ACUVUE® VITA™ contact lens
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's planned enrollment of 65 is below the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →This is the only study on the registry with ApexLens Co., Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
A person is eligible for inclusion in the study if he/she:
Exclusion Criteria:
A person will be excluded from the study if he/she:
Healthy adult males or females age ≥20-45 years of age
Device: 41% Silicone Hydrogel Soft Contact Lenses(SHSCL) · Other: Contact Lens Care Product · Other: Contact Lens Case
Healthy adult males or females age ≥20-45 years of age
Device: ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens · Other: Contact Lens Care Product · Other: Contact Lens Case
Silicone Hydrogel
Senofilcon C (USFDA Device License #K160212)
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
Also known as: Opti-Free Replenish Multi-purpose Disinfecting Solution
"Alcon" Soft (hydrophilic) Contact Lens Case (Non-Sterile)
Also known as: "Alcon" Soft (hydrophilic) Contact Lens Case (Non-Sterile)
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.
Time frame: 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.
Time frame: 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.
Time frame: 13 weeks
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)
Time frame: 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)
Time frame: 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.
Time frame: 13 weeks
Subject reported ocular complaints
Subjects will be asked to assess ocular complaints by using Study Diary.
Time frame: 13 weeks
Plan to share: No
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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