N/A
Completed N=49
On-Eye Evaluation of Contact Lens Axis Location
Myopia · Astigmatism · Refractive error
Source: ClinicalTrials.gov NCT02100410 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear — 24.5; 46.9; 36.7 percentage of lenses
Summary
The purpose of this study was to evaluate the axis location of toric contact lenses after 3 minutes of wear. During this 1-visit study, each participant wore 3 pairs of study lenses of various design iterations (2-87-1, 2-87-2, 2-87-3) for an exposure time of approximately 30 minutes each. Each pair consisted of lenses of the same design iteration, 1 lens with embossed mark [TEST1 (T1), TEST3 (T3), TEST5 (T5)], worn on the right eye, and 1 lens without embossed mark [TEST2 (T2), TEST4 (T4), and TEST6 (T6)] worn on the left eye.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear |
24.5; 46.9; 36.7 | — |
| SECONDARY Lens Awareness |
0.6; 0.2; 0.4; 0.2; 1.0; 0.6 | — |
| SECONDARY Handling on Removal |
8.0; 7.8; 8.9 | — |
Eligibility Criteria
Inclusion Criteria
- Sign written Informed Consent.
- Best corrected distance visual acuity greater than or equal to 20/25 in each eye.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- History of any ocular surgery or ocular injury within 12 weeks of enrollment for this study.
- Anterior segment disease, infection, inflammation, or abnormality that contraindicates contact lens wear.
- History of herpetic keratitis.
- Slit-lamp findings at baseline as specified in the protocol.
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including ocular medications that require instillation during contact lens wear.
- Clinically significant dry eye not responding to treatment.
- History of refractive surgery.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02100410). 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.