Back to resultsClinical Trial Protocol for Safety and Efficacy of Soft Contact Lens
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Contact Lenses
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Tianjin Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Spherical Lens
SiHy Daily
Arm Description
Randomized to Spherical Lens worn in a daily disposable mode
Randomized to SiHy Daily worn in a daily disposable mode
Outcomes
Primary Outcome Measures
The ratio of corrected visual acuity of left and right eyes is ≥5.0
The standard logarithmic visual acuity chart consistent with the guiding principle is adopted in this scheme.
- Success criteria: If the lower limit of 95% CI of the evaluated rate of corrected for visual acuity for both eyes ≥ 5.0 at 1 week visit is ≥-10%, the primary endpoint of the two groups is non-inferior.
The occurrence of adverse events
Compare the number of adverse events and serious adverse events, the number of cases and the incidence rate; list the number and cases of adverse events; describe the adverse events that are related to the investigational products.
Secondary Outcome Measures
BCVA (spectacles) and BCVA (CL)
BCVA (spectacles and CL) of both eyes are compared at baseline and at each follow-up.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04299243
Brief Title
Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens
Official Title
Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens (Model: Spherical Lens)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 25, 2018 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Menicon Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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, and clinical observation is performed for 3 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spherical Lens
Arm Type
Experimental
Arm Description
Randomized to Spherical Lens worn in a daily disposable mode
Arm Title
SiHy Daily
Arm Type
Active Comparator
Arm Description
Randomized to SiHy Daily worn in a daily disposable mode
Intervention Type
Device
Intervention Name(s)
Contact Lenses
Intervention Description
Contact lenses for vision correction
Primary Outcome Measure Information:
Title
The ratio of corrected visual acuity of left and right eyes is ≥5.0
Description
The standard logarithmic visual acuity chart consistent with the guiding principle is adopted in this scheme.
- Success criteria: If the lower limit of 95% CI of the evaluated rate of corrected for visual acuity for both eyes ≥ 5.0 at 1 week visit is ≥-10%, the primary endpoint of the two groups is non-inferior.
Time Frame
1 week
Title
The occurrence of adverse events
Description
Compare the number of adverse events and serious adverse events, the number of cases and the incidence rate; list the number and cases of adverse events; describe the adverse events that are related to the investigational products.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
BCVA (spectacles) and BCVA (CL)
Description
BCVA (spectacles and CL) of both eyes are compared at baseline and at each follow-up.
Time Frame
1 week, 1 month, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Lihua, MD
Organizational Affiliation
Tianjin Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Eye Hospital
City
Tianjin
Country
China
12. IPD Sharing Statement
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Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens
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