Ametropia
Conditions
Interventions
Test group:Use contact lens lubricant
Control group:Use a hard contact lens lubricant.
Sponsors
Affiliated Eye and Vision Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Participants who have worn the rigid gas permeable contact lens (hereinafter referred to as OK lens) for the first time in the research center or have experience in wearing OK lenses; Note: Participants who have experience in wearing OK lenses refer to patients who have previously or are currently wearing OK lenses due to reasons such as fragments or lost lenses. 2. The best corrected visual acuity of the left and right eyes is greater than or equal to 0.8; 3. Age is greater than or equal to 8 years old, gender is not limited; 4. Can understand the purpose of the study, willing to participate in this study, and sign the informed consent form. For participants under the age of 18, their legal guardians are also required to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to contact lens lubricant; 2. Those who cannot use contact lens lubricant as required or cannot undergo regular eye examinations; 3. Those who participated in drug/medical device clinical trials within 30 days before signing the informed consent form and were judged by the investigator to affect the results of the trial; 4. Those who are judged by the investigator to be ineligible for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The improvement in BUT (T3) after using the test product for 30 days compared to BUT (T1) on the day before using the test product.; | — |
Secondary
| Measure | Time frame |
|---|---|
| OSDI questionnaire scale values on the day of wearing the glasses and 30 days after wearing the glasses;;Corneal staining on the day of wearing the glasses and 30 days after wearing the glasses;;Improvement in BUT after 30 minutes of using the trial product in the hospital on the day of wearing the glasses;;BUT improvement after 30 days of wearing the glasses and 30 minutes of using the trial product in the hospital.; | — |
Countries
China
Contacts
Public ContactLu Fan
Affiliated Eye and Vision Hospital of Wenzhou Medical University
Outcome results
None listed