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Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population Phase 2

Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population Phase II

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03586648
Enrollment
71
Registered
2018-07-13
Start date
2018-06-14
Completion date
2018-08-20
Last updated
2020-05-13

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 is a single-masked, randomized-controlled, dispensing clinical trial. A total of approximately 60 eligible hyperopic subjects will be targeted to complete this study.

Interventions

TEST Lens Sphere

CONTROL Lens

CONTROL Lens Sphere

Sponsors

Johnson & Johnson Vision Care, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Potential subjects must satisfy all the following criteria to be enrolled in the study: 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. The subject must be between 40 and 70 years of age (inclusive). 4. The subject's distance spherical equivalent refraction must be in the range of -1.25 D to -3.75 D in each eye. 5. The subject's refractive cylinder must be ≤0.75 D in each eye. 6. The subject's ADD power must be in the range of +0.75 D to +2.50 D. 7. The subject must have distance best corrected visual acuity of 20/20-3 or better in each eye. 8. Subjects must own a wearable pair of spectacles if required for their distance vision. 9. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration). 10. The subject must either already 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.

Exclusion criteria

* Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. Currently pregnant or lactating. 2. Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear. 3. Any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis). 4. 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. 5. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions. 6. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.). 7. A history of amblyopia, strabismus or binocular vision abnormality. 8. Any current ocular infection or inflammation. 9. Any current ocular abnormality that may interfere with contact lens wear. 10. Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral antihistamines (e.g., Chlor-Trimeton, and Benadryl), systemic steroids. 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 or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). 15. Any known hypersensitivity or allergic reaction to Optifree®Replenish® multipurpose care solution or Eye-Cept® rewetting drop solution.

Design outcomes

Primary

MeasureTime frameDescription
Vision Scores2-Week Follow-upOverall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Vision Scores Comparison Between Test and Control2-Week Follow-upOverall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

Countries

United States

Participant flow

Recruitment details

In total, 71 subjects were enrolled in this study of which, 70 subjects were dispensed at least 1 study lens, 1subject failed to meet all eligibility criteria. Of those dispensed a study lens, 61 subjects completed the study while, 9 were discontinued from the study.

Participants by arm

ArmCount
Dispensed Subjects
All subjects dispensed at least one study lens.
70
Total70

Withdrawals & dropouts

PeriodReasonFG000FG001
Period 1Adverse Event10
Period 1Lost to Follow-up11
Period 1Physician Decision01
Period 1Study related symptoms or complaints21
Period 1Withdrawal by Subject01
Period 2Adverse Event10

Baseline characteristics

CharacteristicDispensed Subjects
Age, Continuous56.1 Years
STANDARD_DEVIATION 6.87
Race/Ethnicity, Customized
Black or African American
2 Count of Participants
Race/Ethnicity, Customized
Other
1 Count of Participants
Race/Ethnicity, Customized
White
67 Count of Participants
Region of Enrollment
United States
70 Participants
Sex: Female, Male
Female
59 Participants
Sex: Female, Male
Male
11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 700 / 70
other
Total, other adverse events
0 / 700 / 70
serious
Total, serious adverse events
0 / 700 / 70

Outcome results

Primary

Vision Scores

Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

Time frame: 2-Week Follow-up

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

ArmMeasureGroupValue (MEAN)Dispersion
TestVision ScoresPeriod 142.2 units on a scaleStandard Deviation 13.68
TestVision ScoresPeriod 252.4 units on a scaleStandard Deviation 22.77
ControlVision ScoresPeriod 155.3 units on a scaleStandard Deviation 22.99
ControlVision ScoresPeriod 241.8 units on a scaleStandard Deviation 14.92
Comparison: Data only from the first period will be used if period effect is significant.95% CI: [32.7, 45.9]Linear Mixed Model
Primary

Vision Scores Comparison Between Test and Control

Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

Time frame: 2-Week Follow-up

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

ArmMeasureGroupValue (MEAN)Dispersion
TestVision Scores Comparison Between Test and ControlPeriod 142.2 units on a scaleStandard Deviation 13.68
TestVision Scores Comparison Between Test and ControlPeriod 252.4 units on a scaleStandard Deviation 22.77
ControlVision Scores Comparison Between Test and ControlPeriod 155.3 units on a scaleStandard Deviation 22.99
ControlVision Scores Comparison Between Test and ControlPeriod 241.8 units on a scaleStandard Deviation 14.92
Comparison: The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.95% CI: [-19.7, -3.3]Linear Mixed Model

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026