N/A
Completed N=126
A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens
Source: ClinicalTrials.gov NCT01518868 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Visual Acuity — 0.079; 0.090 logMAR
Summary
The objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
0.079; 0.090 | — |
| SECONDARY Symptoms/Complaints |
95.6; 92.5; 89.4; 81.5; 75.3; 64.9 | — |
Eligibility Criteria
Inclusion Criteria
- Have physiologically normal anterior segments
- Be adapted wearers of soft contact lenses and wear a lens in each eye.
- Be presbyopic and require near add correction in each eye.
- Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction.
- Have no active ocular disease or allergic conjunctivitis.
- Must not be using any topical ocular medications.
- Must habitually use a lens care product for lens cleaning, disinfecting, and storage.
Exclusion Criteria
- Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Anisometropia (spherical equivalent) of greater than 2.00 D.
- Any systemic disease affecting ocular health.
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
- Allergic to any component in the study products.
- Ocular astigmatism of greater than 1.00 D in either eye.
- Have had any corneal surgery (ie, refractive surgery).
- Uses AMO Ultra Care as their habitual lens care regimen.
- Is a toric contact lens wearer.
- Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
- An active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
Data sourced from ClinicalTrials.gov (NCT01518868). 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.