Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses

NCT ID: NCT02366923

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-06-30

Brief Summary

The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.

Detailed Description

The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses. The primary outcome variable for this study is the loss in lens weight over the day, which will indicate the amount of dehydration that has occured.

Conditions

Myopia

Study Design

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

Study Groups

stenfilcon A

Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).

Group Type: EXPERIMENTAL

stenfilcon A

Intervention Type: DEVICE

Each subject randomized to wear either the test or control in either the left of right eye.

delefilcon A

Intervention Type: DEVICE

Each subject randomized to wear either the test or control in either the left of right eye.

delefilcon A

Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).

Group Type: ACTIVE_COMPARATOR

stenfilcon A

Intervention Type: DEVICE

Each subject randomized to wear either the test or control in either the left of right eye.

delefilcon A

Intervention Type: DEVICE

Each subject randomized to wear either the test or control in either the left of right eye.

Interventions

stenfilcon A

Each subject randomized to wear either the test or control in either the left of right eye.

Intervention Type: DEVICE

delefilcon A

Each subject randomized to wear either the test or control in either the left of right eye.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Is at least 17 years of age 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 a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.

5. Is able to wear lenses for at least 12 hours a day.

Exclusion Criteria

1. Is participating in any concurrent clinical 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. 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: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lydon Jones, PhD FC

Role: PRINCIPAL_INVESTIGATOR

Director, Centre for Contact Lens Research

Farah Panjwani, BSc RAQ

Role: PRINCIPAL_INVESTIGATOR

Univerisy of Waterloo

Locations

University of Waterloo School of Optometry

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

EX-MKTG-56

Identifier Type: -

Identifier Source: org_study_id