Clinical trial NCT01582789: Comparative Study of Two Marketed Spherical Soft Contact Lenses
Official title: Clinical Evaluation of CooperVision's Avaira Spherical Daily Wear Soft Contact Lens Versus Vistakon's Oasys Spherical Daily Wear Soft Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2012-04-23
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Comfort - First Intervention
timeFrame: Baseline
measure: Comfort - Second Intervention
timeFrame: Baseline
measure: Comfort - First Intervention
timeFrame: 2 Weeks
measure: Comfort - Second Intervention
timeFrame: 2 Weeks
measure: Comfortable Wearing Time - First Intervention
timeFrame: 2 Weeks
measure: Comfortable Wearing Time - Second Intervention
timeFrame: 2 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pismo Beach
country: United States
facility: Advanced Eyecare
state: California
city: San Diego
country: United States
facility: Eric M. White, OD, Inc.
state: California
Study officials:
affiliation: CooperVision, Inc.
name: Don Siegel, OD
role: STUDY_DIRECTOR
References: