Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses

The purpose of this study was to investigate the overall clinical comfort performance of enfilcon A (test) lens and senofilcon A (control) lens over 15-minutes of lens wear.

Study Overview

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

Detailed Description

This was a non-dispensing, single-masked, randomized, contralateral study comparing Enfilcon A (test) against Senofilcon A (control). Each subject was randomized to wear the test lens in one eye and the control lens in the other eye.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Schaeffer Eye Associates
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Beaches Family Eyecare
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • Todays Eyecare, LLC

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:

1. Based on his/her knowledge, must be in good general health.
2. Be 18 to 38 years old.
3. Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
4. Read, indicate understanding of, and sign Written Informed Consent.
5. Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses (Avaira or Oasys) being evaluated in this trial.
6. Require a visual correction in both eyes.
7. Require a prescription between +8.00D and -12.00D and have less than or equal to 0.75D of astigmatism in both eyes.
8. Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.

9. 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).
   • 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:

1. 0.75D or greater of refractive astigmatism in either eye.
2. Presbyopic or current monovision contact lens wear.
3. Cannot be currently wearing either lenses (Avaira or Oasys).
4. Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation such as iritis; or any infection of the eye, lids, or associated structures.
5. Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.

6. 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)
7. Contact Lens best corrected Snellen visual acuities (VA) worse than 20/30.
8. Aphakia, Keratoconus or a highly irregular cornea.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: enfilcon A; participants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye.	Device: enfilcon A; Test lens; Device: senofilcon A; Control lens
Active Comparator: senofilcon A; participants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye.	Device: enfilcon A; Test lens; Device: senofilcon A; Control lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort at Insertion	Participant's response for comfort at insertion. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at baseline.	Baseline
Comfort at Insertion	Participant's response for comfort at 15 minutes. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at 15 minutes.	15 minutes
Comfort Preference	Participant's response for comfort preference of enfilcon A (test) lens, senofilcon A(control) lens at insertion.	Baseline
Comfort Preference	Participant's response for comfort of enfilcon A (test) lens, senofilcon A (control) lens at 15 minutes wear.	15 minutes

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Study Chair: Donald Siegel, OD, Coopervision, Inc.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: April 30, 2012
• First Submitted That Met QC Criteria: February 4, 2015
• First Posted (Estimate): February 5, 2015

Study Record Updates

• Last Update Posted (Actual): November 23, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: EX-MKTG-38-MTF

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