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Trial record 3 of 5 for:    ketotifen contact lens

Clinical Evaluation of Etafilcon A With Ketotifen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03388138
Recruitment Status : Completed
First Posted : January 2, 2018
Results First Posted : March 16, 2021
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

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.

Condition or disease Intervention/treatment Phase
Visual Acuity Combination Product: etafilcon A with ketotifen Device: 1-Day ACUVUE Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Etafilcon A With Ketotifen
Actual Study Start Date : December 6, 2017
Actual Primary Completion Date : February 9, 2018
Actual Study Completion Date : February 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Active Comparator: K-Lens
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
Etafilcon A with ketotifen

Placebo Comparator: Placebo Contact Lens
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
1-Day ACUVUE




Primary Outcome Measures :
  1. Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population) [ Time Frame: Baseline (Visit 1) and 1-week follow up (Visit 2) ]
    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.

  2. Monocular Contact Lens-corrected Distance Visual Acuity (Modified Intent-to-Treat Population) [ Time Frame: Baseline (Visit 1) and 1-week follow up (Visit 2) ]
    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.


Secondary Outcome Measures :
  1. The Number of Eyes With Clinically Significant Slit Lamp Findings [ Time Frame: Up to 1-Week Follow-up ]
    Slit lamp findings were assessed using a biomicroscope for each subject eye at all scheduled and unscheduled visits. Clinical significant slit lamp findings are defined as Grade 3 or Grade 4. (Grade 0=None, Grade 1=Trace, Grade 2=Mild, Grade 3=Moderate and Grade 4= Severe). The data was dichotomized as 1=Grade 3 or Grade 4 and 0, otherwise. The number of eyes with clinically significant slit lamp findings for each lens type was reported.

  2. The Number of Eyes With Unacceptable Lens Fitting [ Time Frame: Up to 1-Week Follow-up ]
    Lens fit was assessed for each subject and eye using a biomicroscope. Unacceptable lens fit was assessed at all scheduled and unscheduled visits. A subject was deemed to have an unacceptable lens fitting if they met any of the following criteria: (1) Limbal exposure at primary gaze with extreme eye movement, (2) edge lift, (3) excessive movement in primary up gaze, (4) insufficient movement in all three of the following conditions: primary gaze, up gaze and push up test. The number of eyes with unacceptable lens fitting was reported for each lens type.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Potential subjects must satisfy all of 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. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
    3. Between 18 and 39 (inclusive) years of age at the time of baseline visit.
    4. 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.
    5. The subject's contact lens correction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye.
    6. The subject's refractive cylinder must be 1.00 D or less in each eye.
    7. Have a spherocylindrical best corrected visual acuity of 20/30 or better in each eye (Snellen Visual Acuity).

      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 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.
    3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear.
    4. 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.
    5. 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.
    6. Any current use of rewetting drops or ocular medication.
    7. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
    8. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Biomicroscopy Scale.
    9. 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.
    10. Any known hypersensitivity or allergic reaction to ketotifen.
    11. Participation in any eye drop, contact lens or lens care product clinical trial within 14 days prior to study enrollment.
    12. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388138


Locations
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United States, Florida
Vue Optical Boutique
Jacksonville, Florida, United States, 32205
Maitland Vision Center
Maitland, Florida, United States, 32751
St. Lucy's Vision Center
Tampa, Florida, United States, 33625
United States, Kansas
Kannarr Eye Care
Pittsburg, Kansas, United States, 66762
United States, New York
Sacco Eye Group
Vestal, New York, United States, 13850
United States, Virginia
Botetourt Eyecare, LLC
Salem, Virginia, United States, 24153
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
  Study Documents (Full-Text)

Documents provided by Johnson & Johnson Vision Care, Inc.:
Study Protocol  [PDF] October 31, 2017
Statistical Analysis Plan  [PDF] March 29, 2018

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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT03388138    
Other Study ID Numbers: CR-5930
First Posted: January 2, 2018    Key Record Dates
Results First Posted: March 16, 2021
Last Update Posted: March 16, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Ketotifen
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents