Development and Implementation of a Clinical Test to Investigate the Change in Vision With Soft Toric Contact Lenses During Eye Movements
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Astigmatism
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Visual Acuity After Infero-temporal Version Movement.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •They are aged between 18-39 years.
- •They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- •They are willing and able to follow the protocol.
- •They can attain at least 6/9 in each eye with their spectacle refraction.
- •They have successfully worn contact lenses within six months of starting the study.
- •They can be fitted with toric soft contact lenses to match the available power range.
Exclusion Criteria
- •They have an ocular disorder which would normally contra-indicate contact lens wear.
- •They have a systemic disorder which would normally contra-indicate contact lens wear.
- •They are using any topical medication such as eye drops or ointment.
- •They are aphakic.
- •They have had corneal refractive surgery.
- •They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- •They are pregnant or lactating.
- •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.
- •They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Outcomes
Primary Outcomes
Visual Acuity After Infero-temporal Version Movement.
Time Frame: 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.
Time Frame: 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
Time Frame: 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.
Time Frame: 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.