N/A
Completed N=216
A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses
Source: ClinicalTrials.gov NCT01583868 ↗Enrolled (actual)
216
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Visual Acuity — -0.089; -0.087; -0.086; -0.086 logMAR
Summary
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of two RD2135-01 investigational soft contact lenses (Test 1 and Test 2) developed by Bausch + Lomb. The Test lenses will be compared to both Bausch + Lomb PureVision®2 HD (high definition) soft contact lenses and Ciba Vision Air Optix Aqua soft contact lenses when used among currently adapted soft contact lens wearers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
-0.089; -0.087; -0.086; -0.086 | — |
| SECONDARY Symptoms and Complaints |
91.3; 91.3; 83.1; 92.6; 89.6; 88.2 | — |
Eligibility Criteria
Inclusion Criteria
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- Be myopic and require lens correction from -0.50 diopters (D) to -6.00 D in each eye.
- Must agree to wear the study lenses on a daily wear basis for the duration of the study.
- Must be willing to use a lens care system on a regular basis.
- If the subject requires a Washout Period, the subject must be willing to discontinue contact lens wear and be willing to wear either spectacles or no lenses during this Washout Period.
Exclusion Criteria
- Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
- Have an active ocular disease, any corneal infiltrative response or are using any ocular medications.
- Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
- Any scar or neovascularization within the central 4mm of the cornea.
- Any Grade 2 or greater finding during the slit lamp examination, Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
- 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.
- Aphakic.
- Amblyopic.
- Allergic to any component in the study products.
- Have had any corneal surgery (ie, refractive surgery).
- Currently wear monovision correction, multifocal, or toric contact lenses.
- Ocular astigmatism greater than 1.00 D in either eye.
Data sourced from ClinicalTrials.gov (NCT01583868). 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.