Evaluation of the Safety and Efficacy of PEGAVISION Silicone Hydrogel Daily Disposable Soft Contact Lenses (G3)

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.

Inclusion criteria

• Subjects must be at least 18 years of age on the date the ICF is signed and have the capacity to provide voluntary informed consent.
• Subjects must be myopic and require lens correction from -1.00 to -8.00 Diopter (D) with ≤ 1.00 D astigmatism in each eye.
• Subjects must be correctable through spherocylindrical refraction to Log Mar 0.1 or better in each eye.
• Subjects must be adapted to soft contact lens wearers.
• Subjects agree to follow the protocol and are willing to wear their study lenses for at least 8 hours per day at least 5 days per week on a daily disposable wear basis during the study.

Exclusion criteria

• Subjects who exhibit allergies to contact lens materials, contact lens packaging solutions, or possess a history of allergies that contraindicate conventional contact lens wear.
• Subjects live in environments unsuitable for soft lens wear (like areas with dust, chemicals, aerosols).
• Subjects presenting with active ocular conditions. These conditions include, but are not limited to, uveitis, corneal hypoesthesia, corneal epithelial defect, severe dry eye, lacrimal duct defect, glaucoma, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology.
• Use of systemic medications that are known to interfere with contact lenses wear at the investigator's discretion.
• Currently pregnant (to the best of the Subject's knowledge), lactating or planning a pregnancy within the next 3 months
• Any active participation in any contact lens or lens care product clinical trial within fourteen days prior to this study.
• The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
• Subject has a known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
• Subject has a history of papillary conjunctivitis that has interfered with contact lens wear.
• Subject has a history of herpetic keratitis retinal detachment or irregular cornea.
• Subject has a history of recurrent eye or eyelid infections, adverse effects associated with your contact lens wear, intolerance or an unusual response to your contact lens wear.
• The Subject currently has pathological dry eye (tear break-up time ≤ 5 seconds).
• Subjects who have undergone or plan to undergo corneal or intraocular surgery during the study period.