Clinical trial NCT00583908: Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees
Official title: Clinical and Theoretical Evaluation of Factors Affecting Soft Toric Lens Performance: Part 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Keywords: astigmatism
orientation
visual acuity
contact lenses
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Visioncare Research Ltd.
First posted: 2008-01-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the relative performance of a new toric soft contact lens against three toric contact lens currently available in market, specifically with orientation and visual acuity when head is tilted at 90 degrees.

Detailed description: Non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study, \~2 hour duration.

Eligibility criteria: Inclusion Criteria:

1. be at least 18 and less than or equal to 50 years of age
2. be able and willing to adhere to the instructions set forth in the protocol.
3. have a distance spherical component between -1.00 D and -6.00D with cylinder in the range of 0.75 D to 1.75D
4. Sign the STATEMENT OF INFORMED CONSENT.
5. Have normal, healthy eyes

Exclusion Criteria:

1. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear.
2. Pre-existing ocular disease precluding contact lens fitting.
3. Insufficient lacrimal secretions
4. Aphakia, keratoconus or a highly irregular cornea
5. Previous eye surgery involving the anterior segment
6. Current pregnancy or lactation (to the best of the subject's knowledge).
7. Use of concurrent ocular medication
8. Active participation in another clinical study at any time during this study.-

Primary outcomes:
measure: Lens Orientation During Head Tilt.
timeFrame: after fit of each of the four lens insertions
measure: Visual Acuity During Head Tilt
timeFrame: after each of the four lens insertions
Secondary outcomes:
measure: Degree of Lens Rotation in Superior Gaze.
timeFrame: After each of the four lens insertions
measure: Degree of Lens Rotation in Superior-temporal Gaze.
timeFrame: After each of 4 lens insertions.,
measure: Degree of Lens Rotation in Superior-nasal Gaze.
timeFrame: After each of the four lens insertions
measure: Degree of Lens Rotation in Temporal Gaze.
timeFrame: After each of the four lens insertions
measure: Degree of Lens Rotation in Nasal Gaze.
timeFrame: After each of the four lens insertions
measure: Degree of Lens Rotation Inferior-temporal Gaze.
timeFrame: After each of the four lens insertions
measure: Degree of Lens Rotation in Inferior-nasal Gaze.
timeFrame: After each of the four lens insertions
measure: Degree of Lens Rotation in Inferior Gaze.
timeFrame: After each of the four lens insertions
Other outcomes:
Locations:
city: Farnham
country: United Kingdom
facility: Visioncare Research Ltd.
Study officials:
affiliation: Visioncare Research Ltd.
name: Graeme Young, BSc, MPhil
role: PRINCIPAL_INVESTIGATOR
References: