N/A
N=144
Prospective Study of an Investigational Toric Soft Contact Lens
Myopia · Astigmatism · Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT01461811 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) — 98.9; 98.9; 98.9; 97.8 Percentage of eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nelfilcon A toric contact lenses (with comfort additives) (Device); Nelfilcon A toric contact lenses (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- CIBA VISION
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) |
98.9; 98.9; 98.9; 97.8; 98.9; 97.8 | — |
| SECONDARY Subjective Rating of Insertion Comfort |
8.9; 9.0; 9.0; 9.0; 9.0; 9.1 | — |
| SECONDARY Subjective Rating of End of Day Comfort |
7.2; 7.6; 7.6; 7.9; 7.6; 8.2 | — |
| SECONDARY Subjective Rating of Overall Comfort |
8.1; 8.7; 8.3; 8.7; 8.4; 8.8 | — |
| SECONDARY Subjective Rating of End of Day Dryness |
7.1; 7.1; 7.2; 7.6; 7.3; 7.9 | — |
| SECONDARY Subjective Rating of Overall Vision |
8.6; 8.9; 8.7; 8.8; 8.8; 8.9 | — |
| SECONDARY Subjective Rating of Overall Handling |
9.0; 9.0; 8.8; 8.7; 9.0; 8.8 | — |
| SECONDARY Lens Centration (Centered, Slight Decentration) |
97.8; 98.9; 100; 100; 100; 100 | — |
| SECONDARY Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Front Surface Wettability (None, Very Slight) |
99.4; 100; 92.2; 97.8; 94.9; 95.6 | — |
| SECONDARY Front Surface Deposits (None, Very Slight) |
100; 100; 96.1; 100; 98.3; 100 | — |
| SECONDARY Back Surface Debris/Deposits (None, Very Slight) |
100; 100; 98.9; 100; 100; 100 | — |
Summary
The purpose of this study was to demonstrate substantial equivalence of an investigational toric soft contact lens to the commercially available Focus® DAILIES® Toric soft contact lens when worn in a daily wear, daily disposable mode for three months.
Eligibility Criteria
Inclusion Criteria
- Sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and participant must sign Assent document.
- Normal eyes not using any ocular medications that would contraindicate lens wear.
- Willing and able to wear toric contact lenses in both eyes within the available range of powers for this trial.
- Spectacle cylinder prescription between 0.50 and 2.00 diopters.
- Best spectacle corrected visual acuity 20/25 (Snellen) or better in each eye at distance.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Anterior segment infection, inflammation, or abnormality.
- Any active anterior segment or systemic disease that would contraindicate contact lens wear.
- Use of systemic medications that would contraindicate lens wear.
- Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study.
- History of herpetic keratitis.
- History of refractive surgery or irregular cornea.
- History of pathologically dry eye.
- Corneal vascularization greater than 1 mm of penetration.
- Eye injury within twelve weeks immediately prior to enrollment in this trial.
- Participation in a contact lens or contact lens care product clinical trial within the previous 30 days, or concurrent participation in any clinical trial.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01461811). 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.