Evaluating a new silicone hydrogel contact lens for vision correction
A Prospective, Randomized, Double-blind, Parallel, Active-controlled Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of DSiHy Silicone Hydrogel Soft Contact Lens
NA · Visco Vision Inc. · NCT06716372
This study is testing a new silicone hydrogel contact lens to see if it can improve vision and comfort for people with nearsightedness and other vision issues.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Visco Vision Inc. (industry) |
| Locations | 3 sites (Taipei and 2 other locations) |
| Trial ID | NCT06716372 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to assess the safety and effectiveness of the DSiHy Silicone Hydrogel Soft Contact Lens in individuals with myopia and refractive errors. Participants will be randomly assigned to wear either the investigational DSiHy lens or a control group wearing Daily Silicone Hydrogel Contact Lenses. The study employs a double-blind, parallel design to ensure unbiased results. It aims to gather data on visual acuity and comfort while wearing the lenses over a specified period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with myopia and astigmatism who have prior experience wearing soft contact lenses.
Not a fit: Patients with active ocular diseases or significant eye abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a safer and more effective option for vision correction through contact lenses.
How similar studies have performed: Other studies have shown promising results with silicone hydrogel lenses, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taipei and 2 other locations
- Tri-Service General Hospital — Taipei, Taiwan (RECRUITING)
- Chang Gung Memorial Hospital, Taipei — Taipei, Taiwan (NOT_YET_RECRUITING)
- Chang Gung Memorial Hospital, Linkou — Taoyuan, Taiwan (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Peggy Hsu
- Email: peggy.pc.hsu@viscovision.com.tw
- Phone: +886-3-3596868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myopia, Refractive Errors, Contact lens