Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens
Study Details
Study Description
Brief Summary
This project is a multi-center, randomized, parallel-controlled, non-inferior clinical trial of soft contact lenses.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Spherical Lens Randomized to Spherical Lens worn in a daily disposable mode |
Device: Contact Lenses
Contact lenses for vision correction
|
| Active Comparator: SiHy Daily Randomized to SiHy Daily worn in a daily disposable mode |
Device: Contact Lenses
Contact lenses for vision correction
|
Outcome Measures
Primary Outcome Measures
- The ratio of corrected visual acuity of left and right eyes is ≥5.0 [1 week]
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 [3 month]
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) [1 week, 1 month, 3 months]
BCVA (spectacles and CL) of both eyes are compared at baseline and at each follow-up.
Eligibility Criteria
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
- 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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tianjin Eye Hospital | Tianjin | China |
Sponsors and Collaborators
- Menicon Co., Ltd.
Investigators
- Principal Investigator: Li Lihua, MD, Tianjin Eye Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SLP-01