Clinical trial NCT00639379: Comparison of Two Toric Contact Lenses on Current Toric Wearers
Official title: A Multi-Center, Subject Masked, Randomized, Two Week Crossover Design, Investigation of the Acuvue Cypress Toric Silicone Hydrogel Lens Compared to the Bausch & Lomb SofLens66® Toric Hydrophilic Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Keywords: toric contact lenses
vision
comfort
toric fit characteristics
slit lamp findings
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-20
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. 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).
2. Be able to read J1 at near WITHOUT the aid of a near addition over the distance prescription.
3. Be a currently successful wearer for at least 3 months of B\&L SofLens 66 Toric hydrogel lenses.
4. Be able and willing to adhere to the instructions set forth in the protocol.
5. 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.
6. 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).
7. Have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.
8. Be in good general health, based on his/her knowledge.
9. 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:

1. Presbyopic or has the need for a near add for reading.
2. Previous refractive surgery; current or previous orthokeratology treatment.
3. Aphakia, keratoconus or a highly irregular cornea.
4. 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).
5. A known history of corneal hypoesthesia (reduced corneal sensitivity.)
6. Anterior uveitis or iritis (past or present).
7. A history of recurrent erosions, corneal infiltrates corneal ulcer or fungal infections.
8. Clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations or infections of the eye, eyelids, or associated structures.
9. 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
10. Current pregnancy or lactation (to the best of the subject's knowledge).
11. Actively participating in another clinical study at any time during this study.

Primary outcomes:
measure: Lens Orientation Within 5 Degrees
timeFrame: 1 minute after insertion
measure: Lens Stability
timeFrame: 10-15 minutes after insertion
measure: Subjective Lens Comfort
timeFrame: 1 and 2 weeks
measure: Subjective Vision
timeFrame: 1 and 2 weeks
measure: Overall Corneal Staining
timeFrame: after 2 weeks use
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Ted Brink and Associates
state: Florida
city: Orlando
country: United States
facility: Eola Eyes
state: Florida
city: Morrow
country: United States
facility: Clayton Eye Center
state: Georgia
city: St Louis
country: United States
facility: The Koetting Associates Inc.
state: Missouri
city: Concord
country: United States
facility: Southern Eyes
state: North Carolina
city: Beachwood
country: United States
facility: Western Reserve Vision Care
state: Ohio
city: Brentwood
country: United States
facility: Primary Eyecare Group, P.C.
state: Tennessee
Study officials:
References: