Comparative Study of Two Marketed Spherical Soft Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01582789
First received: April 12, 2012
Last updated: March 30, 2016
Last verified: March 2016
  Purpose
The purpose of this study is to obtain objective and subjective clinical data to compare the performance of two soft contact lenses.

Condition Intervention Phase
Refractive Error
Device: enfilcon A
Device: senofilcon A
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparative Study of Two Marketed Spherical Soft Contact Lenses

Resource links provided by NLM:


Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:
  • Comfort - First Intervention [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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,

  • Comfort - Second Intervention [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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,

  • Comfort - First Intervention [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
    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).

  • Comfort - Second Intervention [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
    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).

  • Comfortable Wearing Time - First Intervention [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
    Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for first intervention at week two visit.

  • Comfortable Wearing Time - Second Intervention [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
    Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for second intervention at week two visit.


Enrollment: 61
Study Start Date: April 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: enfilcon A/senofilcon A
enfilcon A daily wear soft contact lens 1st then cross over and subject wears the senofilcon A daily wear soft contact lens 2nd
Device: enfilcon A
enfilcon A daily wear soft contact lens
Other Names:
  • Avaira
  • daily wear
  • soft contact lens
Device: senofilcon A
senofilcon A daily wear soft contact lens
Other Names:
  • Avaira
  • enfilcon A
  • daily wear
  • soft contact lens
Active Comparator: senofilcon A/enfilcon A
senofilcon A daily wear soft contact lens 1st then cross over and subject wears the enfilcon A daily wear soft contact lens 2nd
Device: enfilcon A
enfilcon A daily wear soft contact lens
Other Names:
  • Avaira
  • daily wear
  • soft contact lens
Device: senofilcon A
senofilcon A daily wear soft contact lens
Other Names:
  • Avaira
  • enfilcon A
  • daily wear
  • soft contact lens

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.
  Eligibility

Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582789

Locations
United States, California
Advanced Eyecare
Pismo Beach, California, United States, 93449
Eric M. White, OD, Inc.
San Diego, California, United States, 92123
Sponsors and Collaborators
Coopervision, Inc.
Investigators
Study Director: Don Siegel, OD Coopervision, Inc.
  More Information

Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01582789     History of Changes
Other Study ID Numbers: EX-MKTG-37 
Study First Received: April 12, 2012
Results First Received: February 25, 2016
Last Updated: March 30, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on July 24, 2016