N/A
Completed N=3
On-Eye Evaluation of Contact Lens Rotation Marks
Source: ClinicalTrials.gov NCT02055404 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable) — 42.9; 71.4; 78.6; 46.4 Percentage of assessments
Summary
The purpose of this study was to select the size of the molded rotation mark for a new toric contact lens by comparing the visibility of various molded rotation marks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable) |
42.9; 71.4; 78.6; 46.4; 71.4; 82.1 | — |
Eligibility Criteria
Inclusion Criteria
- Sign Informed Consent document.
- Best corrected distance visual acuity (VA) 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 study enrollment.
- Any ocular disease, infection, inflammation, or abnormality that contraindicates contact lens (CL) wear.
- History of herpetic keratitis.
- Slit-lamp findings greater than grade 2 at baseline.
- Any use of systemic or ocular medications for which CL wear could be contraindicated.
- Inactive corneal neovascularization greater than 1 millimeter of penetration.
- A clinically significant dry eye not responding to treatment.
- History of refractive surgery.
- Participation in a clinical study within the previous 30 days.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02055404). 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.