Myopia Progression After Ceasing Myopia Control Contact Lens Wear

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a continuation study for subjects who were previously fit with test or control lenses; all will stop wearing their study lenses assigned in the previous study and will start to wear an FDA-approved marketed spherical soft contact lens.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluating Accommodative Responses of Soft Contact Lenses for Myopia Control

NCT03635528

Visual Acuity

COMPLETED NA

Clinical Evaluation of Approved Contact Lenses

NCT02699593

Visual Acuity

COMPLETED NA

Visual Performance of Soft Contact Lenses With Myopia Control Optics

NCT05141448

Visual Acuity

COMPLETED

Study of ACUVUE® ADVANCE® PLUS Contact Lenses.

NCT01244893

Myopia

COMPLETED NA

Evaluation of a Daily Disposable Silicone Hydrogel Multifocal Contact Lens in Myopes and Hyperopes

NCT05222880

Visual Acuity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test lens C

Test lens C from previous study

Group Type EXPERIMENTAL

1 Day Acuvue Moist

Intervention Type DEVICE

Lenses will be worn in a daily wear modality

Test lens A

Test lens A from previous study

Group Type ACTIVE_COMPARATOR

1 Day Acuvue Moist

Intervention Type DEVICE

Lenses will be worn in a daily wear modality

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

1 Day Acuvue Moist

Lenses will be worn in a daily wear modality

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. The subject must be enrolled in the parent protocol for at least one year.
2. The subject's parent or legal guardian must read and sign the STATEMENT OF INFORMED CONSENT and the subject must read and sign the Child's Assent Form and be provided a copy of each form.
3. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria

1. Ocular or systemic allergies that may interfere with contact lens wear.
2. Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with contact lens wear.
3. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Any infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV)
8. Diabetes
9. Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study.
10. Strabismus.
11. Pupil or lid abnormality or infection in either eye
12. Central corneal scar in either eye
13. Aphakia in either eye
14. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear.
15. History of participation in prior clinical trials aimed to control myopia progression, except for the parent trial
16. Surgically altered eyes, ocular infection of any type, ocular inflammation.
17. Anterior chamber angle grade 2 or narrower by Van Herrick method.

Minimum Eligible Age

9 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes