N/A
Completed N=14
Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees
Astigmatism
Source: ClinicalTrials.gov NCT00583908 ↗
Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Sep 2009
Primary outcomePrimary: Lens Orientation During Head Tilt. — 12.2; 39.7; 27.6; 39.3 Degree of rotation — p=<0.0001
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.
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 |
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. Informational only — not medical advice.