Clinical trial NCT00697190: Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the fitting characteristics and physiological response of two toric lenses manufactured by Vistakon.


Eligibility criteria: Inclusion Criteria:

* Able to wear study lenses in parameters available.
* At least 18
* understand and sign informed consent
* willing to follow the protocol
* achieve at least 6/9 Visual Acuity (VA), both eyes (OU) with study lenses
* hyperopes: +2.00 to +4.00 with -0.75 D cylinder around 180, high myopes: -6.00 to -8.00 with -1.25 D cylinder around 180
* oblique axis: -2.00 to -4.00 with -0.75 D cyl around 45 or 135, have worn Soft Contact Lenses's within last 6 months

Exclusion Criteria:

* Any ocular or systemic disorder which may contraindicate Contact Lens (CL) wear
* any topical ocular medication
* aphakic
* corneal refractive surgery,
* corneal distortion from hard CL wear or keratoconus
* pregnant or lactating
* grade 2 or worse slit lamp signs
* infectious disease
* previous clinical study within 2 weeks
* don't agree to participate

Primary outcomes:
measure: Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
timeFrame: after 6 hours of wear
measure: Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted)
timeFrame: after 6 hours of wear
measure: Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
timeFrame: after 6 hours of wear
measure: Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
timeFrame: after 6 hours of wear
measure: Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted)
timeFrame: after 6 hours of wear
measure: Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
timeFrame: after 6 hours of wear
measure: Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
timeFrame: after 6 hours of wear
measure: Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted)
timeFrame: after 6 hours of wear
measure: Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
timeFrame: after 6 hours of wear
measure: Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
timeFrame: after 6 hours of wear
measure: Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted)
timeFrame: after 6 hours of wear
measure: Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
timeFrame: after 6 hours of wear
measure: Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)
timeFrame: after 6 hours of wear
measure: Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted)
timeFrame: after 6 hours of wear
measure: Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)
timeFrame: after 6 hours of wear
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research
Study officials:
References: