In-office Evaluation of Two Toric Soft Contact Lenses and a Spherical Soft Contact Lens

Johnson & Johnson (J&J)

Status: Completed

Conditions: Astigmatism

Treatments: Device: etafilcon A sphere; Device: alphafilcon A toric; Device: senofilcon A toric contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT00584727

CR-0714A

Details and patient eligibility

About

The purpose of this study is to determine the relative performance of a new toric soft contact lens against a toric and a spherical contact lens currently available in market, specifically with regards to the fit and visual acuity as well as the comfort, vision and satisfaction while in the practitioner's office. Approximately 2 hours duration.

Full description

Non-dispensing, single-masked (subject-masked), randomised, controlled study.

Enrollment: 96 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. be at least 18 and less than or equal to 39 years of age and have a need for vision correction in BOTH eyes (monovision or uniocular fitting is NOT allowed).
2. be of Asian descent (Japanese, Chinese, Korean, Polynesian or other Asian ancestry) and have Asian Eye anatomy
3. have successfully worn toric or spherical soft (hydrogel or silicone hydrogel) contact lenses for at least 4-weeks prior to enrollment in the study.
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 spherical component between -1.00 D and -5.50 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 20 ° of the horizontal in both eyes
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. read, be given an explanation of, indicate understanding of, and sign the STATEMENT OF INFORMED CONSENT.

Exclusion criteria

1. The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer.

2. The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.

3. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjögren's syndrome, type II diabetes, etc).

4. 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
   • Anterior uveitis or iritis (past or present)
   • Seborrhoeic eczema, seborrhoeic conjunctivitis

5. A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.

6. A known history of corneal hypoesthesia (reduced corneal sensitivity.)

7. Aphakia, keratoconus or a highly irregular cornea.

8. Current pregnancy or lactation (to the best of the subject's knowledge).

9. Active participation in another clinical study at any time during this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

96 participants in 6 patient groups

senofilcon A/alphafilcon A/etafilcon A

Active Comparator group

Description:

First intervention:senofilcon A toric contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: etafilcon A sphere contact lenses

Treatment:

Device: etafilcon A sphere

Device: senofilcon A toric contact lens

Device: alphafilcon A toric

alphafilcon A/etafilcon A/senofilcon A

Active Comparator group

Description:

First intervention: alphafilcon A toric contact lenses Second intervention: etafilcon A sphere contact lenses Third intervention: senofilcon A toric contact lenses

Treatment:

Device: etafilcon A sphere

Device: senofilcon A toric contact lens

Device: alphafilcon A toric

etafilcon A/senofilcon A/alphafilcon A

Active Comparator group

Description:

First intervention: etafilcon A sphere contact lenses Second intervention:senofilcon A toric contact lenses Third intervention: alphafilcon A toric contact lenses

Treatment:

Device: etafilcon A sphere

Device: senofilcon A toric contact lens

Device: alphafilcon A toric

senofilcon A/etafilcon A/alphafilcon A

Active Comparator group

Description:

First intervention: senofilcon A toric contact lenses Second intervention: etafilcon A sphere contact lenses Third intervention: alphafilcon A toric contact lenses

Treatment:

Device: etafilcon A sphere

Device: senofilcon A toric contact lens

Device: alphafilcon A toric

alphafilcon A/senofilcon A/etafilcon A

Active Comparator group

Description:

First intervention: alphafilcon A toric contact lenses Second intervention: senofilcon A toric contact lenses Third intervention: etafilcon A sphere contact lenses

Treatment:

Device: etafilcon A sphere

Device: senofilcon A toric contact lens

Device: alphafilcon A toric

etafilcon A/alphafilcon A/senofilcon A

Active Comparator group

Description:

First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses

Treatment:

Device: etafilcon A sphere

Device: senofilcon A toric contact lens

Device: alphafilcon A toric