Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses

NCT02366923 | Completed Results

• 1 other identifier: EX-MKTG-56
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (4)

• Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A

  Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).

  12 Hours of Wear

• Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A

  Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).

  12 Hours of Wear

• Moisture Retention (Mean) of Stenfilcon A and Delefilcon A

  Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).

  12 Hours of Wear

• Moisture Retention (Median) of Stenfilcon A and Delefilcon A

  Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).

  12 Hours of Wear

Secondary Outcomes (1)

• Subjective Comfort of Stenfilcon A and Delefilcon A

  Up to 12 Hours of Wear

Study Arms (2)

stenfilcon A

EXPERIMENTAL

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

Device: stenfilcon A; Device: delefilcon A

delefilcon A

ACTIVE COMPARATOR

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

Device: stenfilcon A; Device: delefilcon A

Interventions

stenfilcon A DEVICE

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

delefilcon A; stenfilcon A

delefilcon A DEVICE

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

delefilcon A; stenfilcon A

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Is at least 17 years of age and has full legal capacity to volunteer;
• Has read and signed an information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.
• Is able to wear lenses for at least 12 hours a day.

You may not qualify if:

• Is participating in any concurrent clinical study;
• Has any known active\* ocular disease and/or infection;
• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

University of Waterloo School of Optometry

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A. Vega, OD, Sr. Manager Global Medical Scientific Affairs
• Organization: Coopervision

jvega@coopervision.com

(925) 621-3761

Study Officials

• Lydon Jones, PhD FC

  Director, Centre for Contact Lens Research

  PRINCIPAL INVESTIGATOR

• Farah Panjwani, BSc RAQ

  Univerisy of Waterloo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 19, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 29, 2020
• Results First Posted: March 29, 2016

Record last verified: 2020-07

Locations

CA (1)