A Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of DSiHy Silicone Hydrogel Soft Contact Lens

Launched by VISCO VISION INC. · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to evaluate the safety and effectiveness of a new type of soft contact lens called "DSiHy Silicone Hydrogel Soft Contact Lens" for people with vision problems like myopia (nearsightedness) and astigmatism. Participants will be divided into two groups to wear either the new contact lens or a standard daily silicone hydrogel lens, and the study aims to see how well each lens works for correcting vision.

To be eligible for this trial, you must be at least 18 years old, have specific levels of myopia and astigmatism, and have worn soft contact lenses for at least two months before starting the study. It's important that you don’t have any eye infections or diseases that could interfere with wearing contact lenses. If you join the study, you can expect to wear the assigned lenses for a specified amount of time and follow the study guidelines. Also, you will need to provide your consent before participating. If you're interested, please consult with the study team to see if you qualify!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Must be 18 years of age inclusive
• • 2. Beside myopia and astigmatism, subjects with normal eyes and are not using any ocular medications (excluding ocular lubricants and artificial tears)
• • 3. Best spectacle corrected visual acuity greater than or equal to 1.0 for both eyes
• • 4. With +8.00D \~ -12.00 D spherical component myopia, and ≤1.00 astigmatism (based on manifest refraction measurements)
• • 5. Have worn soft contact lens for at least 2 month prior to the study
• • 6. Willing to comply with the required wearing time
• • 7. Agree to comply with all study procedures, sign and date the informed consent form before starting the clinical study
• Exclusion Criteria:
• • 1. Anterior segment infection, inflammation or abnormality
• • 2. Any active ocular disease that would affect contact lens wear or vision (such as acute and subacute inflammation of the anterior chamber of the eye, eye infection, uveitis, serious palpebral abnormality, corneal hypoesthesia, corneal epithelium abrasion, dry eye and tear duct defection, ocular allergies, highly suspected glaucoma) upon evaluation by the investigators or slit lamp findings
• • 3. Currently using systemic or ocular medications that would contraindicate contact lens wear (such as glaucoma eye drops, steroid anti-inflammatory drops, eye ointments, eye gels and other eye medicines)
• • 4. History of herpetic keratitis
• • 5. History of refractive surgery, keratoconus or irregular cornea
• • 6. Slit lamp findings that are not suitable for inclusion (Details of the grading standards for each eye condition are specified in CIP section 5.7.5)
• • 7. A pathologically dry eye (Schirmer test 1 \<5 mm)
• • 8. Have participated in any contact lens or contact lens care product clinical trials within the previous 1 month (excluding questionnaire types and specimen collection)
• • 9. Currently pregnant, lactating, or planning to be pregnant during the trial
• • 10. Have experienced discomfort when wearing silicone hydrogel contact lens, or a known allergy to hyaluronic acid and sodium alginate
• • 11. Corrected visual acuity in either eye does not reach 1.0 when wearing the trial lens
• • 12. Subjects who are judged by the investigators as unsuitable for the study