Clinical Evaluation of Fitting Investigational Contact Lenses Phase 2

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03168542

Enrollment

Registered

2017-05-30

Start date

2017-05-01

Completion date

2017-05-04

Last updated

2018-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Acuity

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.

Interventions

DEVICEJJVC Fitting Guides

Subjects who are habitual soft spherical or toric contact lens wearers, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guide, with either the Multifocal Contact Lens or an Investigational Toric Multifocal Contact Lens if refractive cylinder power of the eye is between -1.00 to -1.50. The Intervention is approximately 30-90 minutes during a 1 day visit.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Number of Fitting Modifications to Optimize Vision	15 Minutes Post Lens Fitting	The ECP followed the fitting guide to assess the vision provided by the study lenses and determined if a lens change was needed. The ECP modified the lenses based upon the subject's responses in accordance with the Fitting Guide. Two modifications were allowed. The number of modifications required by the ECP to optimize vision was recorded.

Secondary

Measure	Time frame	Description
Subject's Responses to Individual Item 4	15 Minutes Post Lens Insertion	Subjects responses to individual item Where Would You Expect To Go Looking For Information About This Contact Lens? Please Select All That Apply.. The percentage of subject's in each response category was reported.
Subject's Responses to Individual Item 1	15 Minutes Post Lens Insertion	Subjects responses to individual item Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Satisfaction Of These Contact Lenses?. This item had a response set of extremely satisfied, very satisfied, moderately satisfied, slightly satisfied and not at all satisfied. The percentage of subject's in each response category was reported.
Subject's Responses to Individual Item 2	15 Minutes Post Lens Insertion	Subjects responses to individual item Based On Your Experience Today, How Likely Are You To Purchase This Contact Lens?. This item had a response set of extremely likely, very likely, somewhat likely, slightly likely and not at all likely. The percentage of subject's in each response category was reported.
Subject's Responses to Individual Item 5	15 Minutes Post Lens Insertion	Subjects responses to individual item If You Were To Purchase The Study Contact Lenses, With What Frequency Would You Expect To Wear Them?. This item had a response set of All of the time, Usually, Frequently, Sometimes, Rarely and never. The percentage of subject's in each response category was reported.
Subject's Responses to Individual Item 3	15 Minutes Post Lens Insertion	Subjects responses to individual item Please Think About Your Experience Today With The Study Contact Lenses. Please Indicate How You Satisfied You Are With The Overall Contact Lens Fitting Process?. This item had a response set of very satisfied, satisfied, unsure, dissatisfied and very dissatisfied. The percentage of subject's in each response category was reported
Subject's Responses to Individual Item 7	15 Minutes Post Lens Insertion	Subjects responses to individual item How did the new lens you tried as a part of this clinical study Compare To Your Current Vision Correction Solutions?. This item had a response set of Much better, somewhat better, about the same, somewhat worse and much worse. The percentage of subject's in each response category was reported.
Subject's Responses to Individual Item 8	15 Minutes Post Lens Insertion	Subjects responses to individual item Considering your experience with the study contact lens, how excited are you about this lens being available to purchase?. This item had a response set of Very Excited, Excited, Unsure, Unexcited and Very Unexcited. The percentage of subject's in each response category was reported.
Subject's Responses to Individual Item 9	15 Minutes Post Lens Insertion	Subjects responses to individual item How would you rate your overall visual performance with the study contact lens?. This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported.
Subject's Responses to Individual Item 10	15 Minutes Post Lens Insertion	Subjects responses to individual item Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Opinion Of These Contact Lenses?. This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported.
Subject's Responses to Individual Item 6	15 Minutes Post Lens Insertion	Subjects responses to individual item What Are Your Current Vision Correction Solutions?. The percentage of subject's in each response category was reported.

Countries

United States

Participant flow

Recruitment details

A total of 23 subjects were enrolled into this study. Of the enrolled subjects 21 were dispensed a study lens and 2 subjects failed to meet the eligibility criteria. Of the dispensed subjects all 21 completed the study.

Pre-assignment details

This was a non-randomized study. The JJVC fitting guide, subjects responses and eye car practitioner options dictated which study lens the subject was to be fit with. Lens type and lens sequence are not experimental design factors. The first lens pair (Right/Left) on eye was the same lens pair (Right/Left) the subject ended with.

Participants by arm

Arm	Count
Dispensed Subjects All subjects dispensed at least one study lens.	21
Total	21

Baseline characteristics

Characteristic	Dispensed Subjects
Age, Continuous	57.0 Years STANDARD_DEVIATION 6.05
Race/Ethnicity, Customized Black or African American	4 Participants
Race/Ethnicity, Customized White	17 Participants
Region of Enrollment United States	21 Participants
Sex: Female, Male Female	18 Participants
Sex: Female, Male Male	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 21	0 / 14
other Total, other adverse events	0 / 21	0 / 14
serious Total, serious adverse events	0 / 21	0 / 14

Outcome results

Primary

Number of Fitting Modifications to Optimize Vision

The ECP followed the fitting guide to assess the vision provided by the study lenses and determined if a lens change was needed. The ECP modified the lenses based upon the subject's responses in accordance with the Fitting Guide. Two modifications were allowed. The number of modifications required by the ECP to optimize vision was recorded.

Time frame: 15 Minutes Post Lens Fitting

Population: All subjects that completed the study without a major protocol deviation.

Arm	Measure	Value (MEAN)	Dispersion
JJVC Fitting Guides	Number of Fitting Modifications to Optimize Vision	0.21 Lens	Standard Deviation 0.47

95% CI: [0.756, 1]Agresti-Coull confidence interval

Secondary

Subject's Responses to Individual Item 1

Subjects responses to individual item Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Satisfaction Of These Contact Lenses?. This item had a response set of extremely satisfied, very satisfied, moderately satisfied, slightly satisfied and not at all satisfied. The percentage of subject's in each response category was reported.