Status:
COMPLETED
Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens
Lead Sponsor:
Menicon Co., Ltd.
Conditions:
Myopia
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
This project is a multi-center, randomized, parallel-controlled, non-inferior clinical trial of soft contact lenses.
Detailed Description
The test product is the Soft Contact Lens (model: Spherical Lens), and the control product is a commercially available soft contact lens (model: SiHy Daily). The number of enrolled subjects is 148, an...
Eligibility Criteria
Inclusion
- Male or female with age of 18 to 45
- Spherical power: -0.25 to -10.00D
- Cylinder power ≤0.75D and Sph.P:Cyl.P≥3:1, or 1.00D≤ cylinder power ≤1.50D and Sph.P:Cyl.P ≥4:1;
- Both eyes are ametropia, and there is no case where the investigator believes that the soft contact lens cannot be worn;
- : The case of wearing a soft contact lens as referred to in this trial is: i) No eyelid abnormalities or infections; ii) No clinically significant slit lamp findings iii) No other active eye diseases.
- BCVA of the left and right eye subjective refraction is greater than or equal to 5.0.
Exclusion
- Need to use therapeutic ophthalmic drugs, including antibiotics, hormones and compound ophthalmic drugs containing hormones
- Dry eye syndrome
- Any systemic disease contraindications to contact lenses or disease medications can affect the wearing of contact lenses
- Wearing a hard contact lens in the past 6 weeks
- Tear film break-up time is less than or equal to 5s
- Allergic to contact lenses and/or contact lenses
- Keratoconus or other irregular corneal patients
- Soft hydrophilic contact lens wearers are affected by long-term special conditions such as dryness, severe dust or volatile chemicals
- Pregnant, lactating or plan to be pregnant
- Only one eye meets the requirements for enrollment
- Participating in other clinical trials or less than ten days after the end of a soft contact lens clinical trial
- Less than three months after the end of a drug clinical trial
- Determined by the investigator that could not be enrolled
Key Trial Info
Start Date :
November 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT04299243
Start Date
November 25 2018
End Date
June 1 2019
Last Update
March 6 2020
Active Locations (1)
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1
Tianjin Eye Hospital
Tianjin, China