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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

Brief Summary:
This study compares contact lens comfortable wear duration, and signs and symptoms of contact lens discomfort, test versus control.

Condition or disease Intervention/treatment Phase
Contact Lens Discomfort Contact Lens-induced Corneal Disorder Contact Lens Acute Red Eye Contact Lens-induced Corneal Fluorescein Staining Drug: CLM2 topical gel Drug: Placebo topical gel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: A Controlled Phase 2 Study for Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel
Actual Study Start Date : June 27, 2019
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: CLM2 Topical Gel
CLM2 topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime.
Drug: CLM2 topical gel
Active topical gel for forehead dermal application

Placebo Comparator: Placebo Topical Gel
Placebo topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime.
Drug: Placebo topical gel
Placebo topical gel for forehead dermal application




Primary Outcome Measures :
  1. Hours of continuous comfortable contact lens wear [ Time Frame: 21 days ]
    Change in total hours per day

  2. Contact Lens Questionnaire-8 (CLDEQ-8) [ Time Frame: 21 days ]
    Change in total score (0-37 worst)

  3. Berkeley Dry Eye Flow Chart [ Time Frame: 21 days ]
    Change in grade (1-5 worst)

  4. Fluorescein corneal staining [ Time Frame: 21 days ]
    Change in score (0-3 worst)


Secondary Outcome Measures :
  1. Eye discomfort from CLDEQ-8, frequency [ Time Frame: 21 days ]
    Change in score (0-4 worst)

  2. Eye discomfort from CLDEQ-8, intensity [ Time Frame: 21 days ]
    Change in score (0-5 worst)

  3. Glia contact lens symptoms questionnaire [ Time Frame: 21 days ]
    Change in total score (0-64)

  4. Fluorescein conjunctival staining [ Time Frame: 21 days ]
    Change in conjunctival staining (0-3 worst)

  5. Tear film examination by TearScan [ Time Frame: 60-80 minutes ]
    Change in total score (0-3 best)

  6. Tear film examination by TearScan [ Time Frame: 21 days ]
    Change in total score (0-3 best)

  7. Tear film breakup time [ Time Frame: 60-80 minutes ]
    Change in score (seconds)

  8. Tear film breakup time [ Time Frame: 21 days ]
    Change in score (seconds)

  9. Tear meniscus height [ Time Frame: 60-80 minutes ]
    Change in height (mm)

  10. Tear meniscus height [ Time Frame: 21 days ]
    Change in height (mm)

  11. Visual acuity [ Time Frame: 21 days ]
    Change in visual acuity

  12. Tear osmolarity [ Time Frame: 21 days ]
    Change in tear osmolarity (mOsm/L)

  13. Schirmer test [ Time Frame: 21 days ]
    Change in wetting length (mm)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03994406


Contacts
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Contact: Jennifer Ding, OD 510-643-9253 ucbrcrc@berkeley.edu
Contact: Tatyana F. Svitova, PhD 510-642-0853 svitova@berkeley.edu

Locations
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United States, California
UC Berkeley Clinical Research Center Recruiting
Berkeley, California, United States, 94720-2020
Contact: Jennifer Ding, OD    510-643-9252    ucbcrc@berkeley.edu   
Contact: Tatyana F. Svitova, PhD    510-642-0853    svitova@berkeley.edu   
Principal Investigator: Meng C. Lin, OD,PhD,FAAO         
Sub-Investigator: Jennifer Ding, OD         
Sponsors and Collaborators
Glia, LLC
Investigators
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Principal Investigator: Meng C. Lin, OD,PhD,FAAO University of California, Berkeley
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Responsible Party: Glia, LLC
ClinicalTrials.gov Identifier: NCT03994406    
Other Study ID Numbers: CLM-1
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Glia, LLC:
contact lens
ocular erythema
contact lens discomfort
Additional relevant MeSH terms:
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Corneal Diseases
Eye Diseases