Clinical trial NCT00584831: Effect of Eye Movement on Toric Lens Orientation and Visual Acuity
Official title: Development and Implementation of a Clinical Test to Investigate the Change in Vision With Soft Toric Contact Lenses During Eye Movements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Keywords: astigmatism
visual acuity
orientation
contact lenses
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Manchester
First posted: 2008-01-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Acuity After Infero-temporal Version Movement.
timeFrame: 10 minutes after insertion
measure: Visual Acuity After Infero-nasal Version Movement.
timeFrame: 10 minutes after lens insertion
measure: Visual Acuity After Superior-temporal Version Movement
timeFrame: 10 minutes after lens insertion
measure: Visual Acuity After Superior-nasal Version Movement.
timeFrame: 10 minutes after lens insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience
Study officials:
affiliation: Eurolens Research, The University of Manchester Dpt. of Optometry and Neuroscience
name: Philip Morgan, PhD MCOptom
role: PRINCIPAL_INVESTIGATOR
References: