Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens

NCT04299243 | Completed

• 1 other identifier: SLP-01
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• BCVA (spectacles) and BCVA (CL)

  1 week, 1 month, 3 months

Study Arms (2)

Spherical Lens

EXPERIMENTAL

Randomized to Spherical Lens worn in a daily disposable mode

Device: Contact Lenses

SiHy Daily

ACTIVE COMPARATOR

Randomized to SiHy Daily worn in a daily disposable mode

Device: Contact Lenses

Interventions

Contact Lenses DEVICE

Contact lenses for vision correction

SiHy Daily; Spherical Lens

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Menicon Co., Ltd.: lead

Study Sites (1)

Tianjin Eye Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Myopia

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Li Lihua, MD

  Tianjin Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: March 6, 2020
• Study Start: November 25, 2018
• Primary Completion: May 15, 2019
• Study Completion: June 1, 2019
• Last Updated: March 6, 2020

Record last verified: 2020-03

Locations

CN (1)