Evaluating Soft Contact Lens Prototypes for Myopia Control

NCT ID: NCT03408444

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-27
• Study Completion Date: 2019-05-25

Brief Summary

This is a multi-site, prospective, randomized, controlled, double-masked, four-arm-parallel-group, dispensing study. Each subject will be bilaterally fitted with one of four types of test articles and wear contact lenses of the assigned lens type during the entire course of the study. Test articles will be worn a minimum 8 hours per day and 5 days per week (subjects will be encouraged to wear study contact lenses 10 hours or more per day and 7 days per week) in a daily disposable modality for a minimum of 6 months and up to 1 year for a total of 7 scheduled visits.

Conditions

Visual Acuity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EMO-114

Test Lens 1

Group Type: EXPERIMENTAL

EMO-114

Intervention Type: DEVICE

Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.

EMO-116

Test Lens 2

Group Type: EXPERIMENTAL

EMO-116

Intervention Type: DEVICE

Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.

EMO-118

Test Lens 3

Group Type: EXPERIMENTAL

EMO-118

Intervention Type: DEVICE

Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.

EMO-117

Test Lens 4

Group Type: ACTIVE_COMPARATOR

EMO-117

Intervention Type: DEVICE

Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.

Interventions

EMO-114

Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.

Intervention Type: DEVICE

EMO-116

Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.

Intervention Type: DEVICE

EMO-118

Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.

Intervention Type: DEVICE

EMO-117

Subjects between the ages of 7 and 12 years old will be bilaterally fitted with one of the four types of test articles and wear lenses of the assigned lens type during the entire course of the study.

Intervention Type: DEVICE

Other Intervention Names

Test Lens 1; Test Lens 2; Test Lens 3; Test Lens 4

Eligibility Criteria

Inclusion Criteria

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. The subject must read (or be read to), understand, and sign the Statement of Information and Assent and receive a fully executed copy of the form.

2. The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.

3. Appear able and willing to adhere to the instructions set forth in this clinical protocol.

4. Between 7 and 12 years of age (inclusive).

5. Have normal eyes (i.e., no ocular medications or infections of any type).

6. Distance subjective best-sphere refraction must be between -0.75D and -4.50D (inclusive) in each eye.

7. Cylindrical refraction must be 1.00D or less in each eye, by subjective sphero-cylindrical refraction.

8. Have sphero-cylindrical best-corrected visual acuity of 20/25 (ie, 0.8 in decimal convention or 0.10 logMAR) or better in each eye.

9. Cycloplegic objective sphero-cylindrical refraction (by auto refraction) must be between -0.75D and -4.50D in sphere and is 1.00D or less in cylinder in each eye (based on the average of 5 repeated sphero-cylindrical refraction measures).

10. The difference in spherical equivalent power between the two eyes must be less than 1.50D (based on the average of 5 repeated sphero-cylindrical refraction measures).

Exclusion Criteria

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Currently pregnant or lactating.

2. Any systemic allergies, infectious disease (e.g., hepatitis, tuberculosis), autoimmune disease (e.g., rheumatoid arthritis), or other systemic diseases (e.g., diabetes), by the parent or legal guardian's report, which are known to interfere with contact lens wear and/or participation in the study.

3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear.

4. Any current use of ocular topical medication.

5. Any previous or planned ocular or intraocular surgery, including refractive surgery.

6. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

7. Participation in any prior myopia control clinical study in the test group.

8. Current or recent (within 30 days from enrollment) rigid lens wearers.

9. History of orthokeratology treatment or use of other ophthalmic devices (e.g., bifocal, multifocal contact or spectacle lenses) or drugs (e.g., atropine or pirenzepine) for the purpose of controlling myopia progression.

10. Any known hypersensitivity or allergic reaction to EyeCept® (or sponsor approved equivalent) Rewetting Drop Solution.

11. Relatives of employee of investigational clinic (e.g., Investigator, Coordinator, Technician).

12. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to, aphakia, uveitis, ocular hypertension, glaucoma, severe keratoconjunctivitis sicca, history of recurrent corneal erosions, keratoconus, keratoconus suspect, pellucid marginal degeneration, entropion, ectropion, extrusions, chalazia, and recurrent styes.

13. Grade 3 or greater palpebral conjunctival observations or any other grade 2 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, conjunctival injection) on the ISO 11980 classification scale.

14. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.

15. Any central corneal scar

16. Any corneal distortion resulting from ocular diseases or previous hard or rigid gas permeable contact lens wear.

17. Binocular vision abnormality, intermittent strabismus or strabismus.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Shanghai EENT Hospital

Shanghai, , China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-5959

Identifier Type: -

Identifier Source: org_study_id