Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens

Myopia Clinical Trial

Official title:

Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens (Model: Spherical Lens)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04299243
• Other study ID #: SLP-01
• Status: Completed
• Phase: N/A
• Start date: November 25, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: March 2020
• Source: Menicon Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: June 1, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Contact Lenses
Contact lenses for vision correction

Locations

Country	Name	City	State
China	Tianjin Eye Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Menicon Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 week
Primary	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.	3 month
Secondary	BCVA (spectacles) and BCVA (CL)	BCVA (spectacles and CL) of both eyes are compared at baseline and at each follow-up.	1 week, 1 month, 3 months