N/A
N=39
Performance of a Multifocal Contact Lens - Presbyopia Study
Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT02450747 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: The Total Grade of Conjunctival Hyperemia — 4.25; 3.72; 3.51; 3.42 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- etafilcon A MULTIFOCAL (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Total Grade of Conjunctival Hyperemia |
4.25; 3.72; 3.51; 3.42 | — |
| PRIMARY Upper Lid Margin Staining Score |
46.2; 26.9; 28.2; 44.9; 23.1; 24.4 | — |
| PRIMARY Average Corneal Staining Area Grade |
0.04; 0.05; 0.08; 0.06; 0.039; 0.28 | — |
Summary
This is a four week study to evaluate the performance of a multifocal contact lens in habitual wearers of silicone hydrogel multifocal contact lenses.
Eligibility Criteria
Inclusion Criteria
- Healthy adult males or females age 40 to 70 and has full legal capacity to volunteer.
- The subject is a current spherical silicone hydrogel multifocal (SiHy) contact lens wearer (defined as a minimum of 2 days per week for at least 6 hours of Daily Wear contact lenses, for a minimum of one month prior to the study) and willing to wear the study lenses on a daily basis (defined as a minimum of 6 hours of wear per day) for the duration of the study.
- The subject must own a pair of wearable spectacles to wear when they cannot wear the study lenses.
- The subject's optimal vertexed spherical equivalent distance correction must be between +3.50 and -5.50 Diopters (D) (inclusive) in both eyes.
- Subjective refraction cylinder power must be less than or equal to 0.75 D in both eyes.
- Requires a reading addition of +0.75 D to +2.50 D in each eye.
- The subject must have distance and near visual acuity best correctable to logMAR 0.1 (20/25) or better at both distance and near with subjective refraction for each eye.
- The subject must read and sign the Informed Consent form.
- The subject must appear able and willing to adhere the instructions set forth in this clinical protocol.
Exclusion Criteria
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Participant in unrelated research clinical trial within 30 days prior to enrollment;
- Known to have any infectious disease (e.g.hepatitis, tuberculosis) or a contagious immunosuppressive disease.
- Women who are pregnant or lactating or planning a pregnancy at the time of enrollment;
- Ocular or systemic allergies or disease which might interfere with contact lens wear;
- Have any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes.
- Systemic disease or use of medication which might interfere with contact lens wear;
- Any corneal distortion;
- Has any known active* ocular disease and/or infection;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; and only uses rewetting drops on an occasional basis( greater than 2 times per week).
- Is a habitual monovision contact lens wearer wearing contact lenses on extended wear basis or for the past 6 months;
- Diagnosed with Diabetes;
- Is aphakic; or Has entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions.
- Has undergone refractive error surgery;
- Has amblyopia or strabismus;
- Has anisometropia >2 D between both eyes;
- Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Any grade 3.0 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear;
- Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Data sourced from ClinicalTrials.gov (NCT02450747). 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.