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Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994406
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Glia, LLC

Tracking Information
First Submitted Date  ICMJE June 20, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date July 30, 2019
Actual Study Start Date  ICMJE June 27, 2019
Estimated Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Hours of continuous comfortable contact lens wear [ Time Frame: 21 days ]
    Change in total hours per day
  • Contact Lens Questionnaire-8 (CLDEQ-8) [ Time Frame: 21 days ]
    Change in total score (0-37 worst)
  • Berkeley Dry Eye Flow Chart [ Time Frame: 21 days ]
    Change in grade (1-5 worst)
  • Fluorescein corneal staining [ Time Frame: 21 days ]
    Change in score (0-3 worst)
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Hours of continuous comfortable contact lens wear [ Time Frame: 21 days ]
    Change in total hours per day
  • Contact Lens Questionnaire-8 (CLDEQ-8) [ Time Frame: 21 days ]
    Change in total score
  • Berkeley Dry Eye Flow Chart [ Time Frame: 21 days ]
    Change in grade
  • Fluorescein corneal staining [ Time Frame: 21 days ]
    Change in score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Eye discomfort from CLDEQ-8, frequency [ Time Frame: 21 days ]
    Change in score (0-4 worst)
  • Eye discomfort from CLDEQ-8, intensity [ Time Frame: 21 days ]
    Change in score (0-5 worst)
  • Glia contact lens symptoms questionnaire [ Time Frame: 21 days ]
    Change in total score (0-64)
  • Fluorescein conjunctival staining [ Time Frame: 21 days ]
    Change in conjunctival staining (0-3 worst)
  • Tear film examination by TearScan [ Time Frame: 60-80 minutes ]
    Change in total score (0-3 best)
  • Tear film examination by TearScan [ Time Frame: 21 days ]
    Change in total score (0-3 best)
  • Tear film breakup time [ Time Frame: 60-80 minutes ]
    Change in score (seconds)
  • Tear film breakup time [ Time Frame: 21 days ]
    Change in score (seconds)
  • Tear meniscus height [ Time Frame: 60-80 minutes ]
    Change in height (mm)
  • Tear meniscus height [ Time Frame: 21 days ]
    Change in height (mm)
  • Visual acuity [ Time Frame: 21 days ]
    Change in visual acuity
  • Tear osmolarity [ Time Frame: 21 days ]
    Change in tear osmolarity (mOsm/L)
  • Schirmer test [ Time Frame: 21 days ]
    Change in wetting length (mm)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Eye discomfort from CLDEQ-8 [ Time Frame: 21 days ]
    Change in score
  • Glia contact lens symptoms questionnaire [ Time Frame: 21 days ]
    Change in total score
  • Lissamine green conjunctival staining [ Time Frame: 21 days ]
    Change in conjunctival staining
  • Tear film examination by TearScan [ Time Frame: 60-80 minutes ]
    Change in total score
  • Tear film examination by TearScan [ Time Frame: 21 days ]
    Change in total score
  • Tear film breakup time [ Time Frame: 60-80 minutes ]
    Change in score
  • Tear film breakup time [ Time Frame: 21 days ]
    Change in score
  • Tear meniscus height [ Time Frame: 60-80 minutes ]
    Change in height
  • Tear meniscus height [ Time Frame: 21 days ]
    Change in height
  • Visual acuity [ Time Frame: 21 days ]
    Change in visual acuity
  • Tear osmolarity [ Time Frame: 21 days ]
    Change in tear osmolarity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel
Official Title  ICMJE A Controlled Phase 2 Study for Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel
Brief Summary This study compares contact lens comfortable wear duration, and signs and symptoms of contact lens discomfort, test versus control.
Detailed Description The clinical hypothesis is that CLM2 topical gel applied dermally on the forehead twice daily will be more effective than placebo (a) in reducing or eliminating ocular discomfort associated with contact lens wear, (b) prolong hours of comfortable wear, (c) prolong total hours of contact lens wear, (d) improve ease of insertion and removal of contact lens, and ( c) reduces friction between cornea/lens and lens/eyelid, without use of artificial eye drops or gels. One mechanism supporting this hypothesis is preliminary evidence of increased meibum secretion following CLM2 topical gel application.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
1:1, study drug:placebo; block design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
3-digit randomized number assignment with matching by age within 10 years, and within 5 years of lens wear. Study drug:placebo, 1:1.
Primary Purpose: Treatment
Condition  ICMJE
  • Contact Lens Discomfort
  • Contact Lens-induced Corneal Disorder
  • Contact Lens Acute Red Eye
  • Contact Lens-induced Corneal Fluorescein Staining
Intervention  ICMJE
  • Drug: CLM2 topical gel
    Active topical gel for forehead dermal application
  • Drug: Placebo topical gel
    Placebo topical gel for forehead dermal application
Study Arms  ICMJE
  • Experimental: CLM2 Topical Gel
    CLM2 topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime.
    Intervention: Drug: CLM2 topical gel
  • Placebo Comparator: Placebo Topical Gel
    Placebo topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime.
    Intervention: Drug: Placebo topical gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2019
Estimated Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female of any race ≥18 years of age at Visit 1 Screening.
  2. Has provided verbal and written informed consent.
  3. Be able and willing to follow instructions, including participation in all study assessments and visits.
  4. Has been wearing soft contact lens in both eyes at least 2 days per week for at least a month.
  5. Duration of comfortable lens wear daily is less than desired.
  6. Suffers from at least two other symptoms while wearing lens with contact lens discomfort of grade 2 or higher:

    1. Dryness.
    2. Grittiness
    3. Blurred vision
    4. Itching
    5. Conjunctival redness
    6. Burning
    7. Stinging.
    8. Lens awareness
    9. Use of artificial tears or gels two or more times a day during contact lens wear hours.
  7. Berkeley Dry Eye Flow Chart (DEFC) score ≥3.

Exclusion Criteria:

  1. BCVA at baseline <20/40.
  2. Wearing contact lens only in one eye.
  3. Wearers of the following contact lenses: Extended wear, prosthetic, scleral, and intracorneal gas permeable.
  4. Pregnant women or women of childbearing potential who are not using contraception.
  5. Diagnosis of the following autoimmune diseases: Addison's disease, Grave's disease, Hashimoto's thyroiditis, lupus, and Sjogren's syndrome.
  6. Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such dystrophies, infections, etc.
  7. Has a condition or be in a situation that, the opinion of the investigator, that may interfere significantly with the subject's participation in the study. No active ocular condition or disease.
  8. Has a known adverse reaction and/or sensitivity to either study drug or its components.
  9. Unwilling to remove contact lens overnight.
  10. Unwilling to attempt to wear contact lens seven (7) days a week during the study period.
  11. Plan to change brand of contact lens during study period.
  12. Unwilling to wear contact lens for at least 10 hours if comfort permits, or until discomfort requires removal of contact lens prior to 10 hours.
  13. Unwilling to discontinue swimming with immersed head for the duration of the study.
  14. Unwilling to withhold the use of artificial tears, gels, or wetting agents during periods when contact lens is worn during the study period.
  15. Cannot withhold the following medications during the study period:

    antihistamines, some diuretics, antidepressants, antipsychotics, Restasis, Xiidra, Accutane, glaucoma medications, other anti-cholinergics; as well as gabapentin.

  16. Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Ding, OD 510-643-9253 ucbrcrc@berkeley.edu
Contact: Tatyana F. Svitova, PhD 510-642-0853 svitova@berkeley.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03994406
Other Study ID Numbers  ICMJE CLM-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Glia, LLC
Study Sponsor  ICMJE Glia, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Meng C. Lin, OD,PhD,FAAO University of California, Berkeley
PRS Account Glia, LLC
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP