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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
65
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
ApexLens Co., Ltd.
Hsinchu, Taiwan
RECRUITINGBest-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)
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"Alcon" Soft (hydrophilic) Contact Lens Case (Non-Sterile)
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