N/A
N=90
Prospective Study of an Investigational Daily Disposable Contact Lens
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01295905 ↗Enrolled (actual)
90
Serious AEs
1.1%
Results posted
Jun 2012
Primary outcome: Primary: Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity — 111; 58 eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- delefilcon A contact lens (Device); narafilcon B contact lens (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- CIBA VISION
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity |
111; 58 | — |
| SECONDARY Overall Vision |
9.5; 9.1 | — |
| SECONDARY Overall Comfort |
9.3; 8.9 | — |
| SECONDARY Overall Handling |
9.1; 9.1 | — |
Summary
The purpose of this study is to evaluate the performance of an investigational daily disposable contact lens.
Eligibility Criteria
Inclusion Criteria
- Subjects with normal eyes who are not using any ocular medications.
- Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
- Willing and able to wear spherical contact lenses for at least 5 days per week.
- Willing and able to wear spherical contact lenses within the available range of powers of -1.00 diopter(D) to -6.00D in 0.25D steps.
- Best spectacle-corrected visual acuity greater than or equal to 20/25.
- Manifest cylinder less than or equal to 0.75D.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Any active anterior segment ocular disease that would contraindicate contact lens wear.
- Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
- History of refractive surgery or irregular cornea.
- History of pathologically dry eye.
- Eye injury within twelve weeks immediately prior to enrollment for this trial.
- Currently enrolled in any clinical trial.
- Participation in a contact lens or contact lens care product clinical trial within the previous 30 days.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01295905). 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.