Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees

Astigmatism Clinical Trial

Official title:

Clinical and Theoretical Evaluation of Factors Affecting Soft Toric Lens Performance: Part 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583908
• Other study ID #: CR-0710 pt 3
• Secondary ID: ETOR-507(under G
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: May 5, 2015
• Start date: November 2007
• Est. completion date: January 2008

Study information

• Verified date: May 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• 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 three toric contact lens currently available in market, specifically with orientation and visual acuity when head is tilted at 90 degrees.

Description:

Non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study, ~2 hour duration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. be at least 18 and less than or equal to 50 years of age

2. be able and willing to adhere to the instructions set forth in the protocol.

3. have a distance spherical component between -1.00 D and -6.00D with cylinder in the range of 0.75 D to 1.75D

4. Sign the STATEMENT OF INFORMED CONSENT.

5. Have normal, healthy eyes

Exclusion Criteria:

1. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear.

2. Pre-existing ocular disease precluding contact lens fitting.

3. Insufficient lacrimal secretions

4. Aphakia, keratoconus or a highly irregular cornea

5. Previous eye surgery involving the anterior segment

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

7. Use of concurrent ocular medication

8. 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
• balafilcon A toric
toric contact lens
• lotrafilcon B toric
toric contact lens
• omafilcon A
toric contact lens

Locations

Country	Name	City	State
United Kingdom	Visioncare Research Ltd.	Farnham

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.	Visioncare Research Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Orientation During Head Tilt.	Degree of lens rotation on the eye with the head tilted.	after fit of each of the four lens insertions	No
Primary	Visual Acuity During Head Tilt	logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity.; logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.	after each of the four lens insertions	No
Secondary	Degree of Lens Rotation in Superior Gaze.	Degree of lens rotation while participant is gazing up.	After each of the four lens insertions	No
Secondary	Degree of Lens Rotation in Superior-temporal Gaze.	Degree of lens rotation while participant is gazing up and out(towards the temple).	After each of 4 lens insertions.,	No
Secondary	Degree of Lens Rotation in Superior-nasal Gaze.	Degree of lens rotation while participant is gazing up and in(towards the nose).	After each of the four lens insertions	No
Secondary	Degree of Lens Rotation in Temporal Gaze.	Degree of lens rotation while participant is gazing out(towards the temple).	After each of the four lens insertions	No
Secondary	Degree of Lens Rotation in Nasal Gaze.	Degree of lens rotation while participant is gazing in(towards the nose).	After each of the four lens insertions	No
Secondary	Degree of Lens Rotation Inferior-temporal Gaze.	Degree of lens rotation while participant is gazing down and out.	After each of the four lens insertions	No
Secondary	Degree of Lens Rotation in Inferior-nasal Gaze.	Degree of lens rotation while participant is gazing down and in.	After each of the four lens insertions	No
Secondary	Degree of Lens Rotation in Inferior Gaze.	Degree of lens rotation while participant is gazing down.	After each of the four lens insertions	No