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

Astigmatism Clinical Trial

Official title:

Evaluation of Fit and Visual Acuity of the Cypress Toric Lens in Two Phases: Part A: A Non-Dispensing Comparison to SofLens66® Toric and Acuvue® 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00584727
• Other study ID #: CR-0714A
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: May 5, 2015
• Start date: September 2007
• Est. completion date: November 2007

Study information

• Verified date: May 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 39 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• senofilcon A toric contact lens
contact lens
• alphafilcon A toric
contact lens
• etafilcon A sphere
contact lens

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.	Foresight Regulatory Strategies, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Number of eyes with Distance Visual Acuity 20/20 or better	15-20 minutes	No
Primary	Patient Reported Vision	A weighted combined score calculated from individual confort-vision related questions asked on a 1-5 scale, 1=most negative resonse to 5=most positive response, was used to derive vision scores. The analysis shows the difference in outcome between test and control. >0=greater vision, <0=lesser vision.	15-20 minutes	No
Primary	Lens Orientation Within 5 Degrees	Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation.	1 minute	No
Primary	Lens Stability Within 5 Degrees	Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation.	1 minute	No
Primary	Patient Reported Comfort.	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	15-20 minutes	No
Primary	Patient Preference	This outcome measures which lens the subjects preferred to wear.	end of study	No