Senofilcon A Investigational Manufacturing Process

Visual Acuity Clinical Trial

Official title:

Clinical Investigation of Senofilcon A Manufactured Using an Alternate Hydration Process

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951703
• Other study ID #: CR-5509
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: April 2016
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the impact of a new contact lens hydration process

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

• The subject must be at least 18 and not more than 70 years of age.

• The subject's refractive cylinder must be < 0.75D in each eye.

• The subject must have best corrected visual acuity of 20/25 or better in each eye.

• The subject must demonstrate adequate mobility and 20/30 vision OD and OS with the study contact lenses.

• The subject must be a habitual and adapted wearer of ACUVUE® OASYS® Brand contact lens in both eyes.

• 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 Criteria:

• 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.

• Any systemic disease, autoimmune disease, or use of medication, that may interfere with contact lens wear.

• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.

• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

• 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 known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens Solution.

• Any ocular infection.

• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

• Monovision or multi-focal contact lens correction.

• Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.

• History of binocular vision abnormality or strabismus.

• Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self report).

• Suspicion of or recent history of alcohol or substance abuse.

• History of serious mental illness.

• History of seizures.

• Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Related Conditions & MeSH terms

• Comfort
• Overall Vision
• Visual Acuity

Intervention

Device:
• senofilcon A
Control, senfilcon A
• senofilcon A
Test, senofilcon A

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Overall Comfort (Using CLUE )	Contact Lens User Experience Comfort scores (CLUE) is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.	2 weeks
Primary	Subjective Overall Vision (Using CLUE )	Contact Lens User Experience Vision scores (CLUE) is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.	2 weeks