N/A
N=76
One Month Daily Wear Clinical Evaluation of New Prototype Contact Lenses in Habitual and Neophyte Contact Lens Wearers
Visual Correction
Bottom Line
View on ClinicalTrials.gov: NCT02081677 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Corneal Staining (Area) — 11.76; 5.79; 4.17; 6.18 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ACUVUE 2 (Device); Prototype E1 (Device); Prototype E2 (Device); Prototype E3 (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Corneal Staining (Area) |
11.76; 5.79; 4.17; 6.18; 5.29; 4.21 | — |
| PRIMARY Corneal Staining (Depth) |
1.03; 0.45; 0.36; 0.44; 0.53; 0.42 | — |
| PRIMARY Corneal Staining (Type) |
1.03; 0.58; 0.42; 0.59; 0.53; 0.42 | — |
| PRIMARY Limbal Conjunctival Redness |
4.0; 3.50; 3.72; 4.06; 3.93; 3.54 | — |
| PRIMARY Bulbar Conjunctival Redness |
4.04; 4.12; 4.08; 4.24; 4.13; 4.47 | — |
| PRIMARY Visual Acuity (LogMAR) |
-0.15; -0.12; -0.13; -0.13 | — |
| PRIMARY Lens Fitting Characteristics |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY Percentage of Reported Ocular Symptoms (Burning/Stinging) |
5.9; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Corneal Edema |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Conjunctival Injection |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Corneal Neovascularization |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Corneal Staining |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Tarsal Abnormalities |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy) |
0.0; 5.3; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Reported Ocular Symptoms (Dryness) |
5.9; 15.8; 0.0; 0.0; 5.9; 0.0 | — |
| PRIMARY Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation) |
0.0; 5.3; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Reported Ocular Symptoms (Irritation/Discomfort) |
0.0; 5.3; 0.0; 0.0; 5.9; 0.0 | — |
| PRIMARY Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness) |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Reported Ocular Symptoms (Lens Awareness) |
0.0; 10.5; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Reported Ocular Symptoms (Redness) |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Reported Ocular Symptoms (Variable Vision) |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
Summary
There will be four study lenses tested; one marketed lens, and three prototype study lenses. Subjects will be randomized to one of the four study lenses which will be worn in a daily wear modality, with a two week replacement.
Eligibility Criteria
Inclusion Criteria
- The subject must be between 18 and 39 years of age.
- The subject must be able to read and understand English.
- The subject read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
- The subject must not have been a participant in a contact lens or contact lens solution study/investigation in the previous seven days.
- The subject must be willing to wearthe study lenses for at least 6 hours per day, 7 days per week (e.g. does not regularly swim).
- The subject must appear able and willing and able to the adhere to the instructions set forth in this clinical protocol.
- The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -4.00D in each eye.
- The subject's refractive astigamatism must be less than or equal to -1.00D in both eyes.
- The subjet must have best corrected visual acuity of 20/30 (6/9 or +0.20 logMAR) or better in each eye.
- The subject must require a visual correction in both eyes (no monofit or monovision allowed).
- The subject must have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- No amblyopia
- No evidence of lid abnormality or infection (including blepharitis/meibomitis)
- No conjunctival abnormality or infection.
- No clinically significant slit lamp findings (i.e. stromal edema, vascularization, corneal scaring, infiltrates or abnormal opacities).
- No other active ocular diseases.
Exclusion Criteria
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any systemic diseases, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- Clinically significant (Grade 3 or 4) corneal edeam, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid permeable contact lens wear.
- Pregnancy or lactation (subjects who become pregnant during the study will be discontinued).
- No extended wear in the last 3 months.
- Diabetes.
- Infectious diseases (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. HIV).
- Has had refractive surgery.
- Employee of VRF with direct involvement in the study or a family member of the clinic.
Data sourced from ClinicalTrials.gov (NCT02081677). 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.