N/A
N=446
Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT00813761 ↗Enrolled (actual)
446
Serious AEs
0.2%
Results posted
Nov 2011
Primary outcome: Primary: Average Daily Wear Time — 13.57; 13.30 Hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- O2Optix contact lens (Device); Proclear contact lens (Device); ReNu MultiPlus Multi-Purpose Solution (Device); Clear Care Cleaning and Disinfecting Solution (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Daily Wear Time |
13.57; 13.30 | — |
| PRIMARY Average Daily Comfortable Wear Time |
11.96; 11.39 | — |
| PRIMARY Lens Comfort |
8.63; 8.25 | — |
| PRIMARY Frequency of Eye Discomfort |
0.36; 0.46 | — |
| PRIMARY Frequency of Daily Lens Dryness |
0.66; 0.68 | — |
| PRIMARY Frequency of Eye Burning/Stinging |
0.31; 0.31 | — |
| PRIMARY Frequency of Itching |
0.21; 0.21 | — |
| PRIMARY Frequency of Tearing |
0.16; 0.15 | — |
| PRIMARY Average Corneal Fluorescein Type Staining |
0.16; 0.36 | — |
| PRIMARY Average Corneal Fluorescein Staining Area |
0.27; 0.99 | — |
| PRIMARY Limbal Redness |
0.44; 0.49 | — |
| PRIMARY Bulbar Redness |
0.50; 0.56 | — |
| PRIMARY Lower Tarsal Redness |
0.51; 0.57 | — |
| PRIMARY Upper Tarsal Redness |
0.48; 0.55 | — |
| PRIMARY Tarsal Roughness |
0.75; 0.87 | — |
| SECONDARY Intensity of Physiological Outcomes |
2.00; 2.41; 2.48; 2.24; 2.24; 2.10 | — |
| SECONDARY Wearing Time and Comfortable Wearing Time |
14.06; 13.63; 13.49; 13.33; 12.42; 11.93 | — |
| SECONDARY Physiological Responses |
0.20; 0.11; 0.52; 0.32; 0.52; 0.39 | — |
Summary
The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.
Eligibility Criteria
Inclusion Criteria
- Be at least 18 years old.
- Signed Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
- Require a visual correction in both eyes (monovision allowed but not monofit).
- Have a contact lens spherical distance requirement between +6.00D and -9.00D in both eyes.
- Astigmatism of 1.00D or less in the better eye and 1.50D or less in the other eye.
- Be correctable to a visual acuity of 20/30 (6/9) or better in each eye.
- Have normal eyes with no evidence of abnormality or disease.
Exclusion Criteria
- Requires concurrent ocular medication.
- Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- Clinically significant corneal edema, corneal vascularisation, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
- Worn lenses on an extended wear basis in the last 3 months.
- Diabetic.
- Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
- Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
- Abnormal lacrimal secretions.
Data sourced from ClinicalTrials.gov (NCT00813761). 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.