Comparative Study of Two Marketed Spherical Soft Contact Lenses

Clinical Evaluation of CooperVision's Avaira Spherical Daily Wear Soft Contact Lens Versus Vistakon's Oasys Spherical Daily Wear Soft Contact Lens

The purpose of this study is to obtain objective and subjective clinical data to compare the performance of two soft contact lenses.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: enfilcon A; Device: senofilcon A

Detailed Description

The study will evaluate the daily wear performance of the Avaira (enfilcon A) spherical lens during two weeks of wear compared to Vistakon's Oasys (senofilcon A) spherical lens.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pismo Beach, California, United States, 93449
      • Advanced Eyecare
    • San Diego, California, United States, 92123
      • Eric M. White, OD, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects must satisfy the following conditions prior to inclusion in the study:

• Based on his/her knowledge, must be in good general health.
• Be 18 to 38 years old.
• Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
• Read, indicate understanding of, and sign Written Informed Consent.
• Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses being evaluated in this trial.
• Require a visual correction in both eyes.
• Require a prescription between +8.00D and -12.00D and have less than -0.75D of astigmatism in both eyes.
• Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.
• Must be able to wear their lenses at least 10 working days over the next 2-weeks; > 8 hours/day assuming there are no contraindications for doing so.
• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia; no evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes); no clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection); no other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology); no aphakia

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

• Greater than 0.50D of refractive astigmatism in either eye.
• Presbyopic or current monovision contact lens wear.
• Cannot be currently wearing of either lenses (Avaira or Oasys)
• Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
• Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.
• Slit lamp findings that would contraindicate contact lens wear such as: pathological dry eye or associated findings; pterygium, pinguecula or corneal scars within the visual axis; neovascularization > 0.75 mm in from the limbus, giant papillary conjunctivitis (GPC) worse than Grade 1; anterior uveitis or iritis (past or present), seborrheic eczema, seborrheic conjunctivitis, history of corneal ulcer or fungal infections; poor personal hygiene
• A known history of corneal hypoesthesia (reduced corneal sensitivity).
• Contact lens best corrected Snellen visual acuities (VA) worse than 20/30.
• Aphakia, Keratoconus or a highly irregular cornea

To be eligible to enter the study, subjects must have ALL of the inclusion criteria and NONE of the exclusion criteria present.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: enfilcon A/senofilcon A; Subjects were randomized to wear enfilcon A then Senofilcon A for two weeks.	Device: enfilcon A; enfilcon A daily wear soft contact lens; Device: senofilcon A; senofilcon A daily wear soft contact lens
Active Comparator: senofilcon A/enfilcon A; Subjects were randomized to wear senofilcon A then enfilcon A for two weeks	Device: enfilcon A; enfilcon A daily wear soft contact lens; Device: senofilcon A; senofilcon A daily wear soft contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort - First Intervention	Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,	Baseline
Comfort - Second Intervention	Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,	Baseline
Comfort - First Intervention	Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).	2 Weeks
Comfort - Second Intervention	Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).	2 Weeks
Comfortable Wearing Time - First Intervention	Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for first intervention at week two visit.	2 Weeks
Comfortable Wearing Time - Second Intervention	Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for second intervention at week two visit.	2 Weeks

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Study Director: Don Siegel, OD, Coopervision, Inc.

Study record dates

Study Major Dates

• Study Start: April 9, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): July 31, 2012

Study Registration Dates

• First Submitted: April 12, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 23, 2012

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: EX-MKTG-37

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes