The goal of this clinical trial is to learn if PEGAVISION Silicone Hydrogel Daily Disposable Soft Contact Lenses (G3) are safe and effective for vision correction in adults. It will also assess the comfort and overall experience of wearing these lenses. The main questions it aims to answer are: Do PEGAVISION G3 lenses provide vision correction comparable to CooperVision Clariti 1 day contact lenses? What medical problems or discomfort do participants experience when using PEGAVISION G3 lenses? Researchers will compare PEGAVISION G3 lenses to CooperVision Clariti 1 day contact lenses to determine if they are a safe and effective option for daily vision correction.
The clinical trial is designed to evaluate the safety and efficacy of PEGAVISION Silicone Hydrogel Daily Disposable Soft Contact Lenses (G3) in adults who require vision correction for myopia or hyperopia. This is a multicenter, randomized, double-blind, parallel, controlled study comparing the investigational lenses to CooperVision Clariti 1 day contact lenses. Participants will be randomly assigned to either the PEGAVISION G3 lens group or the control group using Clariti 1 day lenses in a 2:1 ratio. They will wear the assigned lenses daily for at least eight hours per day, five days per week, over a three-month period. Throughout the study, participants will undergo regular assessments to measure visual acuity, lens fit, comfort, and overall visual experience. The study aims to determine whether PEGAVISION G3 lenses provide non-inferior vision correction compared to the control lenses, while also evaluating safety through ocular health assessments and adverse event monitoring. Slit-lamp biomicroscopy and other eye health evaluations will be performed to assess any corneal abnormalities, irritation, or other complications. In addition, participants will complete questionnaires on lens comfort and visual quality, and compliance will be monitored through lens usage logs. The study results will help determine whether PEGAVISION G3 lenses are a viable and safe option for daily vision correction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
69
Name: PEGAVISION G3 Silicone Hydrogel Daily Disposable Soft Contact Lenses Type: Medical Device (Investigational) Description: Participants in this arm will wear PEGAVISION G3 daily disposable silicone hydrogel soft contact lenses for three months to evaluate their safety, efficacy, and comfort compared to the control group.
Name: CooperVision Clariti 1 day Soft Contact Lenses Type: Medical Device (Approved Comparator) Description: Participants in this arm will wear Clariti 1 day daily disposable soft contact lenses, serving as the control group for comparison with PEGAVISION G3 lenses. Both interventions involve daily wear for at least 8 hours per day, 5 days per week, over a 3-month period, with periodic assessments of visual acuity, safety, and comfort.
Change in Distance Visual Acuity (VA) Corrected by Contact Lenses
Distance visual acuity (VA), corrected by contact lenses in both eyes, will be measured using the LogMAR chart. The mean LogMAR score at each time point (Day 1, 1 week, 1 month, 2 months, and 3 months) will be used to assess visual performance over time. Unit of Measure: LogMAR (logarithm of the minimum angle of resolution)
Time frame: Day 1, 1 week (±2 days), 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days)
Incidence of Corneal Abnormalities Above Grade 2 on the Efron Grading Scale
Incidence of corneal abnormalities, including corneal edema, epithelial microcysts, corneal staining, limbal/bulbar injection, conjunctival abnormalities, and corneal neovascularization/infiltrates, as assessed using slit-lamp examination and graded with the Efron Grading Scale. Outcome is longitudinal tracking of the same measure (not multiple distinct outcomes
Time frame: up to 12 weeks
Lens Fit and Surface Condition (Coverage)
Lens Fit and Surface Condition Measure: Lens centration, movement, and deposits assessed via slit-lamp biomicroscopy. Time Frame: Assessed at all study visits. Purpose: To compare the on-eye performance and stability of PEGAVISION G3 lenses with control lenses.
Time frame: up to 12 weeks
Adverse Events Monitoring
Adverse Events Monitoring Measure: Number and type of adverse events related to contact lens use. Time Frame: Throughout the entire study duration. Purpose: To monitor potential complications and evaluate the safety profile of PEGAVISION G3 lenses.
Time frame: up to 12 weeks
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