Effect of Eye Movement on Toric Lens Orientation and Visual Acuity

Astigmatism Clinical Trial

Official title:

Development and Implementation of a Clinical Test to Investigate the Change in Vision With Soft Toric Contact Lenses During Eye Movements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00584831
• Other study ID #: CR-0725
• Secondary ID: J07-416
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: May 5, 2015
• Start date: October 2007
• Est. completion date: February 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 relative performance of a new toric soft contact lens against toric contact lenses currently available in market, specifically for visual acuity and lens orientation. The study will be conducted in a staged approach (2 stages).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

1. They are aged between 18-39 years.

2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.

3. They are willing and able to follow the protocol.

4. They can attain at least 6/9 in each eye with their spectacle refraction.

5. They have successfully worn contact lenses within six months of starting the study.

6. They can be fitted with toric soft contact lenses to match the available power range.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.

2. They have a systemic disorder which would normally contra-indicate contact lens wear.

3. They are using any topical medication such as eye drops or ointment.

4. They are aphakic.

5. They have had corneal refractive surgery.

6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

7. They are pregnant or lactating.

8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.

9. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Study Design

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

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• senofilcon A
toric contact lens
• balafilcon A
toric contact lens
• omafilcon A
toric contact lens
• lotrafilcon B
toric contact lens

Locations

Country	Name	City	State
United Kingdom	Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.	University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity After Infero-temporal Version Movement.	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.	10 minutes after insertion	No
Primary	Visual Acuity After Infero-nasal Version Movement.	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.	10 minutes after lens insertion	No
Primary	Visual Acuity After Superior-temporal Version Movement	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.	10 minutes after lens insertion	No
Primary	Visual Acuity After Superior-nasal Version Movement.	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.	10 minutes after lens insertion	No