Effect of Eye Movement on Toric Lens Orientation and Visual Acuity

Not Applicable

Completed

• Conditions: Astigmatism

• Registration Number: NCT00584831
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief 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).

Detailed Description

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

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-31
• Study First Posted: 2008-01-02
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Results First Submitted: 2009-09-24
• Results First Submitted QC: 2011-09-21
• Results First Posted: 2011-11-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Acuity After Infero-temporal Version Movement.	10 minutes after insertion	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.
Visual Acuity After Infero-nasal Version Movement.	10 minutes after lens insertion	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.
Visual Acuity After Superior-temporal Version Movement	10 minutes after lens insertion	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.
Visual Acuity After Superior-nasal Version Movement.	10 minutes after lens insertion	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.

Trial Locations

Locations (1)

Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience; 🇬🇧 Manchester, United Kingdom