Clinical trial NCT00762385: Clinical Comparison of Two Silicone-Hydrogel Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Foresight Regulatory Strategies, Inc.
name: Visioncare Research Ltd.
First posted: 2008-09-30
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses.


Eligibility criteria: Inclusion Criteria:

* The subject must be at least 18 and less than or equal to 39 years of age and have a need for vision correction in both eyes.
* The subject must require a lens power between -1.00 to -6.00D and have no more than 1.00D of corneal cylinder.
* The subject, based on his/her knowledge, must be in good general health.
* The subject must be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluations.
* Subject must be a current adapted daily wearer of soft contact lenses with at least 6 months of CL wear.
* Subject must agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
* Subject must be willing and able to use only the care systems and lubricating drops provided for the study during the 4 week period.
* The subject must read, indicate understanding of and sign the Informed Consent Form.

Exclusion Criteria:

* The subject is a rigid gas permeable (RGP) or daily disposable lens wearer.
* The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures.
* The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.)
* Slit lamp findings that would contraindicate contact lens wear such as:

  * pathological dry eye or associated findings
  * pterygium or corneal scars within the visual axis
  * neovascularization equal to or greater than 1mm in from the limbus
  * history of giant papillary conjunctivitis (GPC) worse than grade 2
  * anterior uveitis or iritis (past or present)
  * seborrhoeic eczema
  * seborrhoeic conjunctivitis
* A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
* A known history of corneal hypoesthesia (reduced corneal sensitivity).
* Contact lens snellen visual acuities (VA) worse than 20/30.
* Aphakia, keratoconus or a highly irregular cornea.
* Current pregnancy or lactation (to the best of the subject's knowledge)
* Any active participation in another clinical study at any time during this study.

Primary outcomes:
measure: Lens Comfort
timeFrame: 1-week, 2- weeks
measure: Comfort Symptoms
timeFrame: 1-week, 2-weeks
Secondary outcomes:
measure: Overall Corneal Staining
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References: