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

Launched by VISCO VISION INC. · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of contact lens called "MSiHy Silicone Hydrogel Soft Contact Lens" to see how safe and effective it is for correcting vision problems like myopia (nearsightedness) and astigmatism. The trial is for adults aged 18 and older who have worn soft contact lenses for at least two months and have good vision with glasses. Participants will be randomly assigned to wear either the new contact lens or a standard monthly silicone hydrogel contact lens, and the study will compare the two to see which performs better.

To participate, you should have relatively healthy eyes without any serious eye conditions or infections, and you should not be using certain eye medications. You'll need to agree to follow the study's guidelines and wear the lenses for the required amount of time. If you're interested and meet the eligibility criteria, you can expect to help researchers learn more about this new lens while receiving close monitoring for your eye health throughout the trial.

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. Allergy to any contact lens care product ingredient
• • 12. Corrected visual acuity in either eye does not reach 1.0 when wearing the trial lens
• • 13. Subjects who are judged by the investigators as unsuitable for the study