N/A
Completed N=9
Daily Disposable Contact Lens Tear Film Study
Source: ClinicalTrials.gov NCT01473160 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: Number of Participants With Corrected Visual Acuity of 0.0 or Better — 9; 9; 9; 9 participants
Summary
The purpose of this study was to evaluate the pre-lens tear film stability of a new CE-marked daily disposable contact lens as compared to a commercially available daily disposable contact lens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Corrected Visual Acuity of 0.0 or Better |
9; 9; 9; 9; 9; 9 | — |
| PRIMARY Pre-Lens Noninvasive Tear Break-Up Time |
12.7; 11.3; 12.2; 13.8; 10.5; 10.1 | — |
| PRIMARY Average Tear Meniscus Height |
28.0; 26.7; 26.0; 24.0; 28.7; 27.1 | — |
| PRIMARY Average Ocular Surface Temperature |
35.6; 35.3; 35.2; 35.2; 35.5; 35.3 | — |
| SECONDARY Subjective Comfort |
9.1; 6.8; 9.0; 6.7; 9.1; 6.3 | — |
| SECONDARY Subjective Vision |
9.0; 7.8; 8.7; 7.8; 8.7; 8.0 | — |
| SECONDARY Number of Participants With Adequate Lens Fit |
9; 9; 9; 9; 9; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Be of legal age of consent and sign Informed Consent document.
- Willing and able to wear spherical contact lenses for 16 hours.
- Willing and able to wear spherical contact lenses within the available range of powers.
- Best corrected spectacle visual acuity equal or better than 20/25 or 6/7.5.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Anterior segment infection, inflammation, or abnormality.
- Any use of systemic medications for which contact lens wear could be contraindicated.
- History of refractive surgery or irregular cornea.
- Currently enrolled in any clinical trial.
- Eye injury within twelve weeks prior to enrollment.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01473160). 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.