N/A
N=14
Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees
Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT00583908 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Sep 2009
Primary outcome: Primary: Lens Orientation During Head Tilt. — 12.2; 39.7; 27.6; 39.3 Degree of rotation — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- senofilcon A (Device); balafilcon A toric (Device); lotrafilcon B toric (Device); omafilcon A (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Orientation During Head Tilt. |
12.2; 39.7; 27.6; 39.3 | <0.0001 sig |
| PRIMARY Visual Acuity During Head Tilt |
0.02; 0.15; 0.07; 0.11 | 0.0083 sig |
| SECONDARY Degree of Lens Rotation in Superior Gaze. |
3.3; 6.0; 3.7; 6.5 | 0.16 |
| SECONDARY Degree of Lens Rotation in Superior-temporal Gaze. |
6.3; 9.4; 4.9; 8.6 | 0.044 sig |
| SECONDARY Degree of Lens Rotation in Superior-nasal Gaze. |
6.2; 5.6; 6.9; 5.8 | 0.78 |
| SECONDARY Degree of Lens Rotation in Temporal Gaze. |
4.1; 7.2; 2.8; 6.6 | 0.11 |
| SECONDARY Degree of Lens Rotation in Nasal Gaze. |
3.2; 7.1; 2.4; 3.3 | 0.061 |
| SECONDARY Degree of Lens Rotation Inferior-temporal Gaze. |
3.9; 5.3; 3.7; 2.5 | 0.17 |
| SECONDARY Degree of Lens Rotation in Inferior-nasal Gaze. |
3.0; 9.0; 5.9; 9.5 | 0.0080 sig |
| SECONDARY Degree of Lens Rotation in Inferior Gaze. |
3.9; 5.0; 4.2; 2.4 | 0.27 |
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.
Eligibility Criteria
Inclusion Criteria
- be at least 18 and less than or equal to 50 years of age
- be able and willing to adhere to the instructions set forth in the protocol.
- have a distance spherical component between -1.00 D and -6.00D with cylinder in the range of 0.75 D to 1.75D
- Sign the STATEMENT OF INFORMED CONSENT.
- Have normal, healthy eyes
Exclusion Criteria
- The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear.
- Pre-existing ocular disease precluding contact lens fitting.
- Insufficient lacrimal secretions
- Aphakia, keratoconus or a highly irregular cornea
- Previous eye surgery involving the anterior segment
- Current pregnancy or lactation (to the best of the subject's knowledge).
- Use of concurrent ocular medication
- Active participation in another clinical study at any time during this study.-
Data sourced from ClinicalTrials.gov (NCT00583908). 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.