N/A N=39 Randomized Single-blind Treatment

Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism

Astigmatism

Bottom Line

View on ClinicalTrials.gov: NCT00697190 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2010

Primary outcome: Primary: Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) — 1.10; 1.23 Units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: senofilcon A toric (Device); galyfilcon A toric (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johnson & Johnson Vision Care, Inc.
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	1.10; 1.23	—
PRIMARY Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted)	1.16; 1.18	—
PRIMARY Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	1.08; 1.14	—
PRIMARY Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	0.97; 1.07	—
PRIMARY Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted)	0.95; 1.00	—
PRIMARY Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	1.01; 1.06	—
PRIMARY Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	0.40; 0.22	—
PRIMARY Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted)	0.19; 0.28	—
PRIMARY Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	0.35; 0.18	—
PRIMARY Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	1.68; 1.69	—
PRIMARY Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted)	0.96; 1.17	—
PRIMARY Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	1.12; 1.42	—
PRIMARY Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	1.09; 1.08	—
PRIMARY Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted)	1.12; 1.21	—
PRIMARY Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	1.01; 1.10	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00697190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.