Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens

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

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin, China
    • TianJin eye hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Menicon Co., Ltd.
• Investigators: Principal Investigator: Li Lihua, MD, TianJin eye hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2018
• Primary Completion (Actual): May 15, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: SLP-01

Drug and device information, study documents

• 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