A Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens

NCT ID: NCT02518490

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2015-10-31

Brief Summary

This was be a randomized, contralateral, double-masked, dispensing study comparing the Study test lens against the control lens over one month of lens wear.

The study results were not used for design validation of test lens.

Detailed Description

Subjects were randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses were used in a daily wear modality for one month.

The study results were not used for design validation of test lens.

Conditions

Myopia

Study Design

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

Study Groups

Sapphire lens

Each subject will be randomized to wear the test lens on one eye and control lens on one eye.

Group Type: EXPERIMENTAL

Sapphire Lens

Intervention Type: DEVICE

Each subject will be randomized to wear the test lens on one eye and control lens on one eye.

enfilcon A

Each subject will be randomized to wear the test lens on one eye and control lens on one eye.

Group Type: ACTIVE_COMPARATOR

enfilcon A

Intervention Type: DEVICE

Each subject will be randomized to wear the test lens on one eye and control lens on one eye.

Interventions

Sapphire Lens

Each subject will be randomized to wear the test lens on one eye and control lens on one eye.

Intervention Type: DEVICE

enfilcon A

Each subject will be randomized to wear the test lens on one eye and control lens on one eye.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects will only be eligible for the study if:

1. Is at least 18 years of age for the USA and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

3. Is willing and able to follow instructions and maintain the appointment schedule;

4. Is an adapted soft contact lens wearer;

5. Requires spectacle lens powers between -0.50 to -6.50 diopters sphere;

6. Has no more than 0.75 diopters of refractive astigmatism;

7. Willing to wear contact lens in both eyes;

8. Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye;

9. To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable.

Exclusion Criteria

• Subjects will not be eligible to take part in the study if:

1. Is participating in any concurrent clinical or research study;

2. Has any known active* ocular disease and/or infection;

3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);

7. Is aphakic;

8. Has undergone refractive error surgery; * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meng Lin

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Center, University of California, Berkeley

Locations

Clinical Research Center, University of California, Berkeley

Berkeley, California, United States

Countries

United States

Other Identifiers

CV-15-46

Identifier Type: -

Identifier Source: org_study_id