CFDA published Clinical Guideline on Rigid Gas Permeable (RGP) Contact Lens and Clinical Guideline on Soft Contact Lens on July 5th, to facilitate the applicants with clinical trial process on the two ophthalmic devices. Both guidelines are final version.
Key points for Clinical Guideline on Rigid Gas Permeable (RGP) Contact Lens:
1. Applicable to the clinical trial of RGP contact lens that use shaping method to temporarily change the corneal morphology to achieve the purpose of correcting refractive error.
2. At least two clinical sites are required.
3. Comparison device should be the ones already approved in China.
4. Main outcome measurement: 30 days of product efficiency. Efficiency endpoints: a. The naked eye vision is greater than or equal to 0.8; b. The residual diopter is less than ±0.50D.
5. The enrollment is no less than 200, and the experimental group is no less than 100.
6. Follow-up time is no less than 12 months.
7. References of the guideline include FDA Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lens.
Key points for Clinical Guideline on Soft Contact Lens:
1. Applicable to soft contact lenses with optical imaging principle and correcting ametropia (excluding soft contact lens for astigmatism with cylindrical design)
2. At least two clinical sites are required.
3. Comparison device should be the ones already approved in China.
4. Efficiency endpoint: corrected vision for both eyes are greater than or equal to 5.0 after 1 week of trial.
5. The enrollment is no less than 120, and the experimental group is no less than 60.
6. Follow-up time is no less than 3 months.
7. References of the guideline include FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lens.
For English version of the two guidelines, please email info@ChinaMedDevice.com. For newly issued 4th batch of clinical exemptions, please also email us.
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