N/A
Completed N=645
Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens
Refractive Ametropia
Source: ClinicalTrials.gov NCT04085328 ↗
Enrolled (actual)
645
Serious AEs
0.4%
Results posted
Jun 2023
Primary outcomePrimary: Distance Visual Acuity (VA) With Study Lenses - Completed Eyes — -0.05; -0.05; -0.05; -0.05 logMAR
Summary
The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance Visual Acuity (VA) With Study Lenses - Completed Eyes |
-0.05; -0.05; -0.05; -0.05; -0.05; -0.05 | — |
| PRIMARY Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes |
-0.04; -0.06; -0.03; -0.05; -0.05; -0.05 | — |
| PRIMARY Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs) |
0.0258; 0.0103 | — |
Eligibility Criteria
Inclusion Criteria
- Able to understand and sign an Informed Consent Form.
- Willing to attend all scheduled study visits as required per protocol.
- Willing and able to wear assigned study lenses as required per protocol.
- Successful wear of spherical daily wear or extended wear frequent replacement soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week.
- Manifest cylinder ≤ 0.75 diopter (D) in each eye.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
- History of eye surgery, including refractive surgery.
- Currently pregnant or breast-feeding.
- Monovision contact lens wearers.
- Daily disposable contact lens wearers.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04085328). 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.