A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week

NCT02500368 | Completed Results

• 1 other identifier: CV-15-36
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 1-week dispensing, double-masked, randomized, bilateral study comparing the test lens against the control lens.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Comfort

  Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.

  Baseline and 1 week

• Dryness

  Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.

  Baseline and 1 week

Secondary Outcomes (20)

• Lens Wettability

  Baseline and 1 week

• Surface Appearance

  Baseline

• Surface Appearance

  1 week

• High Contrast Acuity at High Room Illumination

  Baseline and 1 week

• Lens Deposition

  Baseline and 1 week

Study Arms (2)

silicone hydrogel lens (test)

EXPERIMENTAL

Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.

Device: silicone hydrogel lens (test)

enfilcon A lens (control)

ACTIVE COMPARATOR

Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.

Device: enfilcon A lens (control)

Interventions

silicone hydrogel lens (test) DEVICE

contact lens

silicone hydrogel lens (test)

enfilcon A lens (control) DEVICE

contact lens

enfilcon A lens (control)

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 understood the information consent letter
• Is willing and able to follow instructions and maintain the appointment schedule
• Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses
• Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day.)

You may not qualify if:

• A person will be excluded from the study if he/she:
• Is participating in any concurrent clinical or research 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
• Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
• Is aphakic
• Has undergone corneal refractive 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. Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)
• For the purposes of this study, participants will be excluded\*\*, if currently taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Sr. Manager Clinical Research
• Organization: CooperVision Inc.

PChamberlain@coopervision.com

(925) 730-6754

Study Officials

• Lyndon Jones, PhD FCO

  Center for Contact Lens Research, University 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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: July 16, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 29, 2020
• Results First Posted: February 17, 2017

Record last verified: 2020-07

Locations

CA (1)