Evaluating the Efficacy and Safety of Contact Lens Lubricant in Rigid Gas Permeable Corneal Contact Lens Wearers

Inclusion criteria

• Aged 8 and older, no gender limitation;
• Rigid gas permeable corneal contact lens (OK lens) wearers;
• The best corrected distance visual acuity of framed lenses in both eyes can reach 5.0 (5-Point Scale);
• Be able and willing to comply with all treatments and follow-ups;
• Be able to understand the purpose of the trial, participate voluntarily and have ICF signed by the subject himself/herself or his/her legal guardian.

Exclusion criteria

• Patients with only one eye meeting the inclusion criteria.
• Patients with abnormal clinical abnormalities or systemic diseases affecting the eyes that occurred or is occurring before screening and, in the investigator's judgment, preclude the use of corneal contact lenses.
• Patients with some eye diseases that affect contact lens wearing: such as acute or chronic eye diseases, conjunctivitis catarrhalis aestiva, glaucoma, corneal abnormalities, keratoconus, etc.
• Patients with allergies to the components of contact lens or contact lens care solution involved in this trial;
• Patients who are using or need to use drugs that may cause dry eyes or affect vision and corneal curvature (e.g. immunosuppressant, glucocorticoids, IOP-lowering drugs, low concentration atropine) during the study;
• Patients with a history of intraocular operation;
• Patients with abnormal IOP (the single eye IOP <10 mmHg or >21mmHg, or the IOP difference of both eyes >5mmHg), obvious fundus abnormalities, examination of corneal endothelial cell (abnormal ≥ Level 4), or slit-lamp examination abnormalities.
• Patients with dry eye syndrome or with break up time (BUT) <5s.
• Subjects who participated in other drug clinical trials within 90 days before screening, and participated in other medical device clinical trials within 30 days;
• Patients who wore rigid contact lens (including orthokeratology lens) within the past 30 days;
• Patients who are pregnant, nursing or planning to conceive at the enrollment;
• Patients with contraindications for wearing rigid contact lenses or unsuitable for wearing rigid contact lenses as indicated by examination results;
• Other conditions for which the investigator judged the patient unsuitable for inclusion.