Comparison of Two Toric Contact Lenses on Current Toric Wearers

NCT ID: NCT00639379

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2008-06-30

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

Conditions

Ametropia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

senofilcon A

senofilcon A toric daily wear contact lenses

Group Type: EXPERIMENTAL

senofilcon A toric

Intervention Type: DEVICE

silicone hydrogel toric lens, 2 wk replacement, daily wear

alphafilcon A

alphafilcon A toric daily wear contact lenses

Group Type: ACTIVE_COMPARATOR

alphafilcon A toric

Intervention Type: DEVICE

hydrogel toric lens, 2 wk replacement, daily wear

Interventions

senofilcon A toric

silicone hydrogel toric lens, 2 wk replacement, daily wear

Intervention Type: DEVICE

alphafilcon A toric

hydrogel toric lens, 2 wk replacement, daily wear

Intervention Type: DEVICE

Other Intervention Names

ACUVUE OASYS; SofLens Toric

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

CR-0802

Identifier Type: -

Identifier Source: org_study_id