Comparison of Two Toric Contact Lenses on Current Toric Wearers

Not Applicable

Completed

Brief Summary: 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

Detailed Description: Up to 7 sites in the US will participate. Each investigator will have both test and control lens types. There will be a maximum of 6 scheduled visits:

Visit 1: Habitual lens evaluation / Baseline / Trial fitting Visit 2: Dispensing (to be combined with Visit 1 where possible), Visit 3: Questionnaire only (no exam) 7 days (±2) after dispensing, Visit 4: 2 week follow-up 14 days (±3) after dispensing, and dispense second lens type, Visit 5: Questionnaire only (no exam) 7 days (±2) after 2nd lens dispense, Visit 6: 2 week follow-up 14 days (±3) after 2nd lens dispense

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
senofilcon A	senofilcon A toric	senofilcon A toric daily wear contact lenses
alphafilcon A	alphafilcon A toric	alphafilcon A toric daily wear contact lenses

Primary Outcome Measures

Name	Time	Method
Overall Corneal Staining	after 2 weeks use	Corneal staining measured using the National Eye Institute grading scale of grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.
Subjective Lens Comfort	1 and 2 weeks	A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. \>0=comfortable, \<0=uncomfortable.
Subjective Vision	1 and 2 weeks	A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive response, was used to derive vision outcomes. The analysis shows the difference in outcome between the test and control. \>0=satisfactory vision, \<0=unsatisfactory vision.
Lens Stability	10-15 minutes after insertion	Number of eyes with the amount of rotation induced from a blink within 5 degrees of settled orientation.
Lens Orientation Within 5 Degrees	1 minute after insertion	Number of eyes with lens orientation within 5 degrees of optimal orientation within 1 minute of contact lens insertion.

Secondary Outcome Measures

Name	Time	Method

Locations (7): Southern Eyes
🇺🇸
Concord, North Carolina, United States
Western Reserve Vision Care
🇺🇸
Beachwood, Ohio, United States
Eola Eyes
🇺🇸
Orlando, Florida, United States
Ted Brink and Associates
🇺🇸
Jacksonville, Florida, United States
Primary Eyecare Group, P.C.
🇺🇸
Brentwood, Tennessee, United States
The Koetting Associates Inc.
🇺🇸
St Louis, Missouri, United States
Clayton Eye Center
🇺🇸
Morrow, Georgia, United States