Recruitment

Recruitment Status
Completed
Estimated Enrollment
130

Inclusion Criterias

The subject must be at least 18 and not more than 70 years of age.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be a habitual and adapted wearer of ACUVUE® OASYS® Brand contact lens in both eyes.
...
The subject must be at least 18 and not more than 70 years of age.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be a habitual and adapted wearer of ACUVUE® OASYS® Brand contact lens in both eyes.
The subject must have best corrected visual acuity of 20/25 or better in each eye.
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
The subject's refractive cylinder must be < 0.75D in each eye.
The subject must demonstrate adequate mobility and 20/30 vision OD and OS with the study contact lenses.
The subject must have normal eyes (i.e., no ocular medications or infections of any type).
The subject's required spherical contact lens prescription must be in the range of -0.50 to -9.00D in each eye.

Exclusion Criterias

Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Monovision or multi-focal contact lens correction.
Any ocular infection.
...
Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Monovision or multi-focal contact lens correction.
Any ocular infection.
Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
Any systemic disease, autoimmune disease, or use of medication, that may interfere with contact lens wear.
Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self report).
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
History of binocular vision abnormality or strabismus.
Suspicion of or recent history of alcohol or substance abuse.
History of serious mental illness.
History of seizures.
Any known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens Solution.

Summary

Conditions
  • Comfort
  • Overall Vision
  • Visual Acuity
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

To evaluate the impact on clinical performance of senofilcon A lenses manufactured using an alternate hydration process and compare the performance with senofilcon A lenses manufactured using the current process.

To evaluate the impact on clinical performance of senofilcon A lenses manufactured using an alternate hydration process and compare the performance with senofilcon A lenses manufactured using the current process.

Inclusion Criterias

The subject must be at least 18 and not more than 70 years of age.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be a habitual and adapted wearer of ACUVUE® OASYS® Brand contact lens in both eyes.
...
The subject must be at least 18 and not more than 70 years of age.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be a habitual and adapted wearer of ACUVUE® OASYS® Brand contact lens in both eyes.
The subject must have best corrected visual acuity of 20/25 or better in each eye.
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
The subject's refractive cylinder must be < 0.75D in each eye.
The subject must demonstrate adequate mobility and 20/30 vision OD and OS with the study contact lenses.
The subject must have normal eyes (i.e., no ocular medications or infections of any type).
The subject's required spherical contact lens prescription must be in the range of -0.50 to -9.00D in each eye.

Exclusion Criterias

Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Monovision or multi-focal contact lens correction.
Any ocular infection.
...
Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Monovision or multi-focal contact lens correction.
Any ocular infection.
Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
Any systemic disease, autoimmune disease, or use of medication, that may interfere with contact lens wear.
Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self report).
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
History of binocular vision abnormality or strabismus.
Suspicion of or recent history of alcohol or substance abuse.
History of serious mental illness.
History of seizures.
Any known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens Solution.

Locations

Jacksonville, Florida, 32256
Warwick, Rhode Island, 02888
Bloomington, Illinois, 61701
Pittsburg, Kansas, 66762
...
Jacksonville, Florida, 32256
Warwick, Rhode Island, 02888
Bloomington, Illinois, 61701
Pittsburg, Kansas, 66762

Tracking Information

NCT #
NCT01951703
Collaborators
Not Provided
Investigators
Study Director: Brian Pall, OD Johnson & Johnson Vision Care