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

NCT02537717 | Completed Results FDA Device

• 1 other identifier: CV-15-55
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a 1-month dispensing, double-masked, randomized, contralateral study comparing the test lens against the control lens. The assignment of lenses to eyes (i.e. which lens type is to be worn in which eye throughout the study) will be selected according to a randomization table.

Conditions

Myopia

Outcome Measures

Primary Outcomes (9)

• Subjective Ratings of Comfort

  Subjective ratings of Comfort on a 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

  Baseline (After 10 minutes of lens dispense)

• Subjective Ratings of Comfort

  Subjective ratings of Comfort on a 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

  2 weeks

• Subjective Ratings of Comfort

  Subjective ratings of Comfort on a 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

  4 weeks

• Subjective Comfort Preference

  Subjective comfort preference Sapphire lens, Enfilcon A, no preference

  Baseline (after 10 minutes of lens dispense)

• Subjective Comfort Preference

  Subjective comfort preference Sapphire lens, Enfilcon A, no preference

  2 weeks

• Subjective Comfort Preference

  Subjective comfort preference Sapphire lens, Enfilcon A, no preference

  4 weeks

• Lens Wettability

  Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)

  Baseline (After 10 minutes of lens dispense)

• Lens Wettability

  Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)

  2 weeks

• Lens Wettability

  Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)

  4 weeks

Study Arms (2)

Sapphire lens

EXPERIMENTAL

Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.

Device: Sapphire Lens

enfilcon A

ACTIVE COMPARATOR

Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.

Device: enfilcon A

Interventions

Sapphire Lens DEVICE

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

Sapphire lens

enfilcon A DEVICE

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

enfilcon A

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 or 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:

• 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). Rationale is that systemic changes over time due to pregnancy/lactating may adversely affect contact lens wear e.g. ocular dryness may increase.
• 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: Myhanh Nguyen
• Organization: CooperVision, Inc.

mnguyen@coopervision.com

925-730-6716

Study Officials

• Lyndon Jones

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 2, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: April 29, 2016
• Last Updated: November 19, 2020
• Results First Posted: October 27, 2020

Record last verified: 2020-10

Locations

CA (1)