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This trial aims to evaluate the safety and effectiveness of LACRIFRESH OCU-DRY 0.3% OSD, a contact lens lubricant produced by AVIZOR, S.A. This clinical trial adopts a Multi-center, randomized, open-label, positive parallel-controlled design in accordance with the principles outlined in the Norms on the Quality Management for the Clinical Trials of Medical Devices issued by the National Medical Products Administration of China.
Meanwhile, following statistical requirements, 152 rigid contact lens wearers are planned to be enrolled after screening and meeting the inclusion criteria. Participants will be randomly assigned to groups and provided with lenses, lubricants, and care solutions accordingly. Clinical follow-up assessments are scheduled at 1 week, 1 month, and 3 months after use.
The primary efficacy indexes are the percentage of patients with binocular comfort score ≥ Level 3 at the 1-month follow-up and the percentage of patients with best corrected distance visual acuity with contact lenses for both eyes ≥5.0 at the 1-month follow-up after using the contact lens lubricant. Secondary efficacy indexes include, best corrected distance visual acuity with lenses, visual acuity with lenses, residual diopter, tear break-up time, uncorrected visual acuity, examination of contact lens fitting status, lens assessment, and contact lens lubricant evaluation during the corresponding follow-up periods. Safety indexes include slit lamp examination, fundus examination, IOP, corneal endothelial cell, adverse events, serious adverse events, device defects that may lead to serious adverse events, other device defects during the corresponding follow-up periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tested medical device | Experimental | LACRIFRESH OCU-DRY 0.3% OSD |
|
| Control medical device | Active Comparator | Rigid contact lens lubricant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LACRIFRESH OCU-DRY 0.3% OSD | Device | Use LACRIFRESH OCU-DRY 0.3% OSD as the daily contact lens lubricant product. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with comfort scores ≥ Level 3 for both eyes at the 1-month follow-up after using the contact lens lubricant. | 1 month | |
| Percentage of subjects with the best corrected distance visual acuity in both eyes with lenses ≥5.0 at the 1-month follow-up after using the contact lens lubricant. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in subjective symptoms assessed by subjective acceptability Scale of National Medical Products Administration(NMPA) | According to the Guidelines for Registration Review of Contact Lens Care Products of NMPA, subjective acceptability of contact lens care products is investigated through the investigation of subjective symptoms during follow-up, specifically including evaluations of comfort, visual and operability assessments. Higher scores indicate a more favorable outcome for the endpoint. For comfort assessment, the 6-point scale is defined as follows: Level 0: Painful; Level 1: Extremely uncomfortable; Level 2: Mildly uncomfortable; Level 3: Comfortable; Level 4: Very comfortable; Level 5: Excellent. For visual and operability assessments, the 6-point scale is defined as follows: Level 0: Unacceptable; Level 1: Very poor; Level 2: Poor; Level 3: Good; Level 4: Very good; Level 5: Outstanding. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanhong Li | Contact | +86(0)1060356258 | lyh@cisema.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Aier Intech Eye Hospital | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Rigid contact lens lubricant | Device | Use Rigid contact lens lubricant as the daily contact lens lubricant product. |
|
| 1 week, 1 month, and 3 months |
| Changes in best corrected distance visual acuity with lenses | 1 week, and 3 months |
| Changes in lens wearing vision and residual diopter | 1 week, 1 month, and 3 months |
| Changes in tear break up time (TBUT) | 1 week, 1 month, and 3 months |
| Changes in uncorrected visual acuity | 1 week, 1 month, and 3 months |
| Changes in contact lens fitness examination | 1 week, 1 month, and 3 months |
| Changes in lens assessment | 1 week, 1 month, and 3 months |
| Changes in contact lens lubricant evaluation | 1 week, 1 month, and 3 months |
| Changes in slit-lamp examinations | 1 week, 1 month, and 3 months |
| Changes in fundus examinations | 1 month and 3 months |
| Comparison between groups for intraocular pressure (IOP) at each follow-up visit, along with changes relative to baseline | 1 week, 1 month, and 3 months |
| Comparison between groups for examination of corneal endothelial cell at each follow-up visit, along with changes relative to baselineChanges | 3 months |
| Incidence of adverse events | From the date of randomization until the occurrence of adverse events, assessed for up to 3 months |
| Incidence of serious adverse event | From the date of randomization until the occurrence of serious adverse event, assessed for up to 3 months |
| Tianjin Eye Hospital | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
|
| Tianjin Medical University Eye Hospital | Recruiting | Tianjin | Tianjin Municipality | 300380 | China |
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