Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Contact Lenses

• Registration Number: NCT04299243
• Lead Sponsor: Menicon Co., Ltd.

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.

Study Timeline

• Study Start: 2018-11-25
• Primary Completion: 2019-05-15
• Study Completion: 2019-06-01
• Study First Submitted: 2020-02-18
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-04
• Last Update Submitted: 2020-03-04
• Study First Posted: 2020-03-06
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spherical Lens	Contact Lenses	Randomized to Spherical Lens worn in a daily disposable mode
SiHy Daily	Contact Lenses	Randomized to SiHy Daily worn in a daily disposable mode

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Tianjin Eye Hospital; 🇨🇳 Tianjin, China