Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses

Completed · Not applicable

Conditions studied: Astigmatism

In brief

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.

Key facts

Study ID

NCT02356692

Run by

CooperVision, Inc.

People needed

60

Starts

2012-04-01

Expected to finish

2012-05-01

Last updated by the study team

2020-11-23

Who can join

Age: 18 and older, up to 38. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 (Avaira or Oasys) 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 or equal to 0.75D of astigmatism in both eyes.
• Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.
• 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.

You may not qualify if…

• 0.75D or greater of refractive astigmatism in either eye.
• Presbyopic or current monovision contact lens wear.
• Cannot be currently wearing either lenses (Avaira or Oasys).
• Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation 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.

Where it is running

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

Full record on ClinicalTrials.gov

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