Guideline For Clinical Trial Of Soft Contact Lenses

1. Scope
   This document is established to provide guidance on planning and execution of pre-market
   clinical trials of daily wear soft contact lenses.
   the recommendations apply to daily wear soft contact lenses which are based on optical
   imaging principles to correct ametropia (but does not include the soft contact lenses which
   are based on cylindrical design to correct astigmatism). Pre-market clinical trials for soft
   contact lenses with additional functions should be designed according to those special
   characteristics.
2. Principles
   Clinical trials of soft contact lenses should comply with the same Quality Management
   Standards for Clinical Trials of Medical Devices and other applicable laws and regulations.
   The soft contact lenses (Materials and designs?) for pre-market clinical trials should have
   been verified by appropriate scientifically valid studies and animal testing, with results
   should demonstrate products’ safety and effectiveness.
3. Clinical Trial Plan
   3.1 Clinical trial objectives and precautions
   The objective of clinical trial of soft contact lenses is to evaluate whether the product has
   the expected safety and effectiveness. A standard logarithmic visual acuity chart is
   recommended for clinical trials. Visual acuity test should be conducted by using standard
   methods. For multi-center clinical trials, the visual acuity chart used in different clinical trial
   facilities must be consistent. If diopter is one of the testing items, the subjects’ subjective
   optometry values (including spherical degree and cylindrical degree) should be the
   endpoint; the objective optometry values (including spherical degree and cylindrical degree)
   should be considered as reference only.
   Since the Clinical Trial Plan is the document to clarify the overall design and purpose of the
   test, test method and process, etc., subjects’ safety and health should be protected to the
   greatest extent. Clinical Trial Plan should be established according to the prescribed format
   by both sponsor and investigator and approved by ethics committees before the Clinical
   Trial Plan is implemented. Any changes to the plan should be reviewed and approved by
   ethics committees.
   3.2 Clinical trial design
   Guideline for Clinical Trial of Soft Contact Lenses

The clinical trials for market application of soft contact lenses should be prospective,
randomized and controlled, and should be conducted in two or more medical device clinical
trial centers. If the clinical trials are conducted by following a same clinical trial protocol in
three or more than three clinical trial centers, this clinical trial will be considered as a
multicenter clinical trial. The medical device which is selected as control device should be
similar to the test device and have been approved for listing in China. The functional
principle, wearing approach, and wearing period should be the same as test product. The
material of lenses should be similar, and historical control or non-parallel control is not
recommended.
3.3 Sample size of clinical trials
Indicator for evaluation: Degree of effectiveness of wearing the lenses.
Definition of effectiveness: The corrected visual acuity of both eyes should be measured
while the lenses are worn and evaluated after one week. If the corrected visual acuity of
both eyes is greater than or equal to 5.0 according to standard logarithmic visual acuity
chart), the product is “effective”.
The test hypothesis is created and the sample size was calculated based on the evidencebased medical related data of the corresponding indicators of the control product. The
determination of the sample size should be based on the type of hypothesis test selected
(superior, non-inferiority, or equivalence test) and type I and II errors, as well as clinically
significant cut-off values (poor efficacy). The exclusion and the number of cases of loss of
follow-up should also be considered while determining sample size.
The clinical trial sample size should be determined to fulfill the purpose and statistical
requirements of the clinical trial, and the subjects who completed all visits should not be
less than the minimum sample size specified in this guidance. Currently, the evaluation of
effectiveness and safety should comply with clinically accepted evaluation criteria. Each
evaluation case should include binocular data. The final sample of clinical trials should be no
less than 120 cases. The inferior boundary value is not more than 10%, and the test group is
not less than 60 cases