Clinical Evaluation of Etafilcon A With Ketotifen

NCT03388138 | Completed Phase 2 Results FDA Drug FDA Device

• 1 other identifier: CR-5930
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 6

Brief Summary

This clinical study is a randomized, double-masked, bilateral, controlled, two-arm parallel group, multi-site, 1-Week, 2-visit dispensing study. Subjects between the ages of 18-40 will be randomized into a placebo arm or an investigational K-Lens arm.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (2)

• Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population)

  Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit.

  Baseline (Visit 1) and 1-week follow up (Visit 2)

• Monocular Contact Lens-corrected Distance Visual Acuity (Modified Intent-to-Treat Population)

  Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit.

  Baseline (Visit 1) and 1-week follow up (Visit 2)

Secondary Outcomes (2)

• The Number of Eyes With Clinically Significant Slit Lamp Findings

  Up to 1-Week Follow-up

• The Number of Eyes With Unacceptable Lens Fitting

  Up to 1-Week Follow-up

Study Arms (2)

K-Lens

ACTIVE COMPARATOR

etafilcon A with ketotifen. Subjects between the ages of 18-40 will be randomized into the K-Lens arm and will be scheduled for a total of two study visits with approximately 6-9 days in between.

Combination Product: etafilcon A with ketotifen

Placebo Contact Lens

PLACEBO COMPARATOR

1-Day Acuvue. Subjects between the ages of 18-40 will be randomized into the Placebo arm and will be scheduled for a total of two study visits with approximately 6-9 days in between.

Device: 1-Day ACUVUE

Interventions

etafilcon A with ketotifen COMBINATION_PRODUCT

Etafilcon A with ketotifen

K-Lens

1-Day ACUVUE DEVICE

1-Day ACUVUE

Placebo Contact Lens

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study
• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• Appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Between 18 and 39 (inclusive) years of age at the time of baseline visit.
• The subject must be a habitual lens wearer for a least 6 days/week and for a minimum of 8 hours per day over the last month.
• The subject's contact lens correction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye.
• The subject's refractive cylinder must be 1.00 D or less in each eye.
• Have a spherocylindrical best corrected visual acuity of 20/30 or better in each eye (Snellen Visual Acuity).

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Currently pregnant or lactating.
• Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
• Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear.
• Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear, history of strabismus, or current monovision, multi-focal, or toric contact lens correction.
• Any current use of rewetting drops or ocular medication.
• Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Biomicroscopy 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 would contraindicate contact lens wear.
• Any known hypersensitivity or allergic reaction to ketotifen.
• Participation in any eye drop, contact lens or lens care product clinical trial within 14 days prior to study enrollment.
• Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (6)

Vue Optical Boutique

Jacksonville, Florida, 32205, United States

Location

Maitland Vision Center

Maitland, Florida, 32751, United States

Location

St. Lucy's Vision Center

Tampa, Florida, 33625, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

Botetourt Eyecare, LLC

Salem, Virginia, 24153, United States

Location

MeSH Terms

Interventions

Ketotifen

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Brian Pall O.D, MS, FAAO
• Organization: Johnson & Johnson Vision Care, Inc.

bpall@its.jnj.com

1-800-843-2020

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 2, 2018
• Study Start: December 6, 2017
• Primary Completion: February 9, 2018
• Study Completion: February 9, 2018
• Last Updated: March 17, 2022
• Results First Posted: March 16, 2021

Record last verified: 2022-03

Locations

US (6)