N/A
N=40
Effect of Eye Movement on Toric Lens Orientation and Visual Acuity
Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT00584831 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcome: Primary: Visual Acuity After Infero-temporal Version Movement. — 0.12; 0.1; 0.16; 0.14 LogMAR units — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- senofilcon A (Device); balafilcon A (Device); omafilcon A (Device); lotrafilcon B (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity After Infero-temporal Version Movement. |
0.12; 0.1; 0.16; 0.14 | 0.02 sig |
| PRIMARY Visual Acuity After Infero-nasal Version Movement. |
0.12; 0.11; 0.14; 0.15 | 0.02 sig |
| PRIMARY Visual Acuity After Superior-temporal Version Movement |
0.11; 0.08; 0.13; 0.14 | 0.02 sig |
| PRIMARY Visual Acuity After Superior-nasal Version Movement. |
0.14; 0.10; 0.15; 0.16 | 0.02 sig |
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).
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.
Data sourced from ClinicalTrials.gov (NCT00584831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.