Clinical trial NCT02310126: Handling Comparison Between Two Contact Lens Types
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-05
Enrollment: 195
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Subjects will evaluate each study lens in a random order. The lenses will be worn in both eyes for a short period.


Eligibility criteria: Inclusion Criteria:

1. The subject must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be between 40 and 70 years of age.
4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of +0.25 to +4.00 or plano to -6.00 in each eye.
5. The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.
6. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
7. The subject best corrected visual acuity of 20/20 -3 or better in each eye.
8. Subject must own a wearable pair of spectacles.
9. The subject must be an adaptable soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per day, for 1 month or more of duration)
10. The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not responded positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Any ocular abnormality that may interfere with contact lens wear.
5. Use of any ocular medication, with the exception of rewetting drops.
6. Any previous intraocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
7. Any grade 3 or greater slit lamp finding (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
8. Any ocular infection or inflammation.
9. History of herpetic keratitis.
10. Any corneal distortion or irregular cornea.
11. History of binocular vision abnormality or strabismus.
12. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
13. Current history of diabetes.
14. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

Primary outcomes:
measure: Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire.
timeFrame: 15 minutes post Contact Lens Insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Baymeadows Vision Center
state: Florida
city: Jacksonville
country: United States
facility: Eye Elements Eyecare
state: Florida
city: Jacksonville
country: United States
facility: Vistakon Research Clinic
state: Florida
city: Sarasota
country: United States
facility: Golden Family Eyecare
state: Florida
city: Winter Park
country: United States
facility: Eye Associates of Winter Park
state: Florida
city: Columbus
country: United States
facility: Central Ohio Eyecare
state: Ohio
city: Memphis
country: United States
facility: Optometry Group LLC
state: Tennessee
city: Nashville
country: United States
facility: Nashville Vision Associates
state: Tennessee
Study officials:
References: