Performance of a Multifocal Contact Lens - Presbyopia Study

NCT02450747 | Completed Results

• 1 other identifier: CR-5692
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Presbyopia

Keywords

Visual Acuity

Outcome Measures

Primary Outcomes (3)

• The Total Grade of Conjunctival Hyperemia

  Hyperemia (Redness) was assessed using two different parts of the eye, the Bulbar and the Limbal. Hypemeria was measured using the Efron Scale in 0.5 step units. Grade 0= No Findings, Grade 1= Slight, Grade 2= Mild , Grade 3= Moderate and Grade 4 = severe. Hypermia was assessed in four regions of the eye (Inferior, Nasal, Temporal and Superior). The total grade of Conjunctival Hypermia across all regions and grades is reported. The total grade can range from 0 to 8. Where a higher grade implies worsening conjunctival hypermia

  Baseline to 4-Week Follow-up

• Upper Lid Margin Staining Score

  Upper Lid Margin Staining was assessed using Fluorescein Staining and was measured on the Graded Scale is Grade 0: No Staining is present, Grade 1= 1% to 25% Stains, Grade 2= 26% to 50% Stains, Grade 3= 51% to 75% Stains, Grade 4 76% to 100% Stains. The percentage of eyes with upper lid margin staining for each Grade is reported.

  Baseline to 4-Week Follow-up

• Average Corneal Staining Area Grade

  Corneal staining Area Grade was assessed in throughout five (5) regions in the eye (Central, Nasal, Temporal, Inferior, Superior). Corneal Staining was Graded using the Efron scale from 0 to 4 in 0.1 unit steps and converted to a percentage of region that was stained. The average percent of region that was stained was calculated and reported.

  Baseline to 4- Week Follow-up

Study Arms (1)

Multifocal Test Contact Lens

EXPERIMENTAL

Subjects will wear the etafilcon A Multifocal test lens in a daily wear modality.

Device: etafilcon A MULTIFOCAL

Interventions

etafilcon A MULTIFOCAL DEVICE

Subjects will wear the test lens for four weeks.

Multifocal Test Contact Lens

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Unknown Facility

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Tom Karkkainen O.D., M.S., F.A.A.O- Sr. Research Principal Optometrist
• Organization: Johnson & Johnson Vision Care Inc.

TKarkkai@its.jnj.com

904-443-3500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: May 21, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 19, 2018
• Results First Posted: January 12, 2017

Record last verified: 2016-11

Locations

CA (1)