Comparison of Two Toric Contact Lenses on Current Toric Wearers

Completed · Not applicable

Conditions studied: Ametropia

In brief

The purpose of this study is to evaluate and compare the clinical performance of two toric contact lenses amongst 110 subjects, 2-week, single masked (subject), daily wear, randomized, bilateral, crossover study; 4 weeks duration. Hypotheses include equal or better performance of the test lens over the control lenses for comfort, vision, and toric fit characteristics as well as corneal integrity

Key facts

Study ID

NCT00639379

Run by

Johnson & Johnson Vision Care, Inc.

People needed

89

Starts

2008-02-01

Expected to finish

2008-06-01

Last updated by the study team

2015-05-21

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Be at least 18 and less than or equal to 45 years of age, have a need for vision correction and wear contact lenses in BOTH eyes (monovision or uni-ocular fitting is NOT allowed).
• Be able to read J1 at near WITHOUT the aid of a near addition over the distance prescription.
• Be a currently successful wearer for at least 3 months of B\&L SofLens 66 Toric hydrogel lenses.
• Be able and willing to adhere to the instructions set forth in the protocol.
• 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.
• Have a distance spectacle spherical component between -1.00 D and -5.25 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 30° of the horizontal in both eyes (when the subject's prescription is presented in minus cylinder form).
• Have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.
• Be in good general health, based on his/her knowledge.
• Must be given an explanation of the study objectives, lens and solutions usage requirements and visit schedule. The subject must read, indicate understanding of and agree to begin participation in the clinical study. The subject must then sign the Informed Consent Form in the presence of the Investigator or their designee.

You may not qualify if…

• Presbyopic or has the need for a near add for reading.
• Previous refractive surgery; current or previous orthokeratology treatment.
• Aphakia, keratoconus or a highly irregular cornea.
• The presence of ocular or systemic disease or has the need for medication (ocular or systemic) which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (e.g., Sjögren's syndrome, type II diabetes, allergies).
• A known history of corneal hypoesthesia (reduced corneal sensitivity.)
• Anterior uveitis or iritis (past or present).
• A history of recurrent erosions, corneal infiltrates corneal ulcer or fungal infections.
• Clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations or infections of the eye, eyelids, or associated structures.
• 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 >1mm in from the limbus
• History of giant papillary conjunctivitis (GPC) worse than Grade 2
• Meibomian gland dysfunction, blepharitis, or seborrhoeic dermatitis
• Current pregnancy or lactation (to the best of the subject's knowledge).
• Actively participating in another clinical study at any time during this study.

Where it is running

• Ted Brink and Associates — Jacksonville, Florida, United States
• Eola Eyes — Orlando, Florida, United States
• Clayton Eye Center — Morrow, Georgia, United States
• The Koetting Associates Inc. — St Louis, Missouri, United States
• Southern Eyes — Concord, North Carolina, United States
• Western Reserve Vision Care — Beachwood, Ohio, United States
• Primary Eyecare Group, P.C. — Brentwood, Tennessee, United States

Full record on ClinicalTrials.gov

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