Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens

Menicon

Status

Completed

Conditions

Myopia

Treatments

Device: Contact Lenses

Study type

Interventional

Funder types

Industry

Identifiers

NCT04299243

SLP-01

Details and patient eligibility

About

This project is a multi-center, randomized, parallel-controlled, non-inferior clinical trial of soft contact lenses.

Full 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.

Enrollment

148 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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