Clinical trial NCT02356692: Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses
Official title: Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comfort at Insertion
timeFrame: Baseline
measure: Comfort at Insertion
timeFrame: 15 minutes
measure: Comfort Preference
timeFrame: Baseline
measure: Comfort Preference
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Schaeffer Eye Associates
state: Alabama
city: Jacksonville
country: United States
facility: Beaches Family Eyecare
state: Florida
city: Lafayette
country: United States
facility: Todays Eyecare, LLC
state: Louisiana
Study officials:
affiliation: CooperVision, Inc.
name: Donald Siegel, OD
role: STUDY_CHAIR
References: