Clinical trial NCT03168542: Clinical Evaluation of Fitting Investigational Contact Lenses Phase 2
Official title: Clinical Evaluation of Fitting Investigational Contact Lenses Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-30
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: While this study utilizes two contact lenses, the purpose was to evaluate the JJVC fitting guide. This was a non-randomized study in which eye care practitioners used the JJVC fitting guide to fit subjects with a study contact lens. Subjects may fit either in a bilateral or a contralateral fashion.
Primary purpose: TREATMENT

Brief summary: This study is a single arm, non-randomized, open label, bilateral, non- dispensing clinical trial with only one visit. The Eye Care Providers will be provided with a fitting guide and will determine the initial study lens selection. Each subject will wear either the investigational contact lenses or marketed contact lenses for approximately 30-90 minutes. This study aims to evaluate the ECPs impression of the fitting guide for a novel multifocal lens and also their success in fitting the lenses.


Eligibility criteria: Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Healthy adult males or females that are at least 40 years of age and no more than 70 years of age.
4. The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
5. The subject is a current soft spherical or toric contact lens wearer (defined as a minimum of 6 hours of wear per day at least two days of the week for a minimum of 1 month prior to the study).
6. The subject's distance spherical equivalent or spherical component (if the eye has - 1.00 to -1.50 D of refractive cylinder) of their refraction must be in the range -1.25 D to -3.75 D or +1.25 D to +3.75 D in each eye.
7. The subject's refractive cylinder cannot be greater than -1.50D in either eye.
8. The subject's refractive cylinder axis must be 90°±30° or 180°±30° in each eye.
9. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
10. The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
11. The subject must have a wearable pair of spectacles if required for their distance vision.

Exclusion Criteria:

1. Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
2. Pregnancy or lactation.
3. Currently diagnosed with diabetes.
4. Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
5. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
6. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
7. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
8. A history of amblyopia, strabismus or binocular vision abnormality.
9. Any ocular infection or inflammation.
10. Any ocular abnormality that may interfere with contact lens wear.
11. Use of any ocular medication, with the exception of rewetting drops.
12. History of herpetic keratitis.
13. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
14. Employee of clinical site (e.g., Investigator, Coordinator, Technician)

Primary outcomes:
measure: Number of Fitting Modifications to Optimize Vision
timeFrame: 15 Minutes Post Lens Fitting
Secondary outcomes:
measure: Subject's Responses to Individual Item 1
timeFrame: 15 Minutes Post Lens Insertion
measure: Subject's Responses to Individual Item 2
timeFrame: 15 Minutes Post Lens Insertion
measure: Subject's Responses to Individual Item 3
timeFrame: 15 Minutes Post Lens Insertion
measure: Subject's Responses to Individual Item 4
timeFrame: 15 Minutes Post Lens Insertion
measure: Subject's Responses to Individual Item 5
timeFrame: 15 Minutes Post Lens Insertion
measure: Subject's Responses to Individual Item 6
timeFrame: 15 Minutes Post Lens Insertion
measure: Subject's Responses to Individual Item 7
timeFrame: 15 Minutes Post Lens Insertion
measure: Subject's Responses to Individual Item 8
timeFrame: 15 Minutes Post Lens Insertion
measure: Subject's Responses to Individual Item 9
timeFrame: 15 Minutes Post Lens Insertion
measure: Subject's Responses to Individual Item 10
timeFrame: 15 Minutes Post Lens Insertion
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Vistakon Research Clinic
state: Florida
Study officials:
References: