search
Back to results

Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel

Primary Purpose

Contact Lens Discomfort, Contact Lens-induced Corneal Disorder, Contact Lens Acute Red Eye

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CLM2 topical gel
Placebo topical gel
Sponsored by
Glia, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contact Lens Discomfort focused on measuring contact lens, ocular erythema, contact lens discomfort

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UC Berkeley Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CLM2 Topical Gel

Placebo Topical Gel

Arm Description

CLM2 topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime.

Placebo topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime.

Outcomes

Primary Outcome Measures

Hours of continuous comfortable contact lens wear
Change in total hours per day
Contact Lens Questionnaire-8 (CLDEQ-8)
Change in total score (0-37 worst)
Berkeley Dry Eye Flow Chart
Change in grade (1-5 worst)
Fluorescein corneal staining
Change in score (0-3 worst)

Secondary Outcome Measures

Eye discomfort from CLDEQ-8, frequency
Change in score (0-4 worst)
Eye discomfort from CLDEQ-8, intensity
Change in score (0-5 worst)
Glia contact lens symptoms questionnaire
Change in total score (0-64)
Fluorescein conjunctival staining
Change in conjunctival staining (0-3 worst)
Tear film examination by TearScan
Change in total score (0-3 best)
Tear film examination by TearScan
Change in total score (0-3 best)
Tear film breakup time
Change in score (seconds)
Tear film breakup time
Change in score (seconds)
Tear meniscus height
Change in height (mm)
Tear meniscus height
Change in height (mm)
Visual acuity
Change in visual acuity
Tear osmolarity
Change in tear osmolarity (mOsm/L)
Schirmer test
Change in wetting length (mm)

Full Information

First Posted
June 20, 2019
Last Updated
March 23, 2023
Sponsor
Glia, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT03994406
Brief Title
Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel
Official Title
A Controlled Phase 2 Study for Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 27, 2019 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glia, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Lens Discomfort, Contact Lens-induced Corneal Disorder, Contact Lens Acute Red Eye, Contact Lens-induced Corneal Fluorescein Staining
Keywords
contact lens, ocular erythema, contact lens discomfort

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
1:1, study drug:placebo; block design.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CLM2 Topical Gel
Arm Type
Experimental
Arm Description
CLM2 topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime.
Arm Title
Placebo Topical Gel
Arm Type
Placebo Comparator
Arm Description
Placebo topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime.
Intervention Type
Drug
Intervention Name(s)
CLM2 topical gel
Intervention Description
Active topical gel for forehead dermal application
Intervention Type
Drug
Intervention Name(s)
Placebo topical gel
Intervention Description
Placebo topical gel for forehead dermal application
Primary Outcome Measure Information:
Title
Hours of continuous comfortable contact lens wear
Description
Change in total hours per day
Time Frame
21 days
Title
Contact Lens Questionnaire-8 (CLDEQ-8)
Description
Change in total score (0-37 worst)
Time Frame
21 days
Title
Berkeley Dry Eye Flow Chart
Description
Change in grade (1-5 worst)
Time Frame
21 days
Title
Fluorescein corneal staining
Description
Change in score (0-3 worst)
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Eye discomfort from CLDEQ-8, frequency
Description
Change in score (0-4 worst)
Time Frame
21 days
Title
Eye discomfort from CLDEQ-8, intensity
Description
Change in score (0-5 worst)
Time Frame
21 days
Title
Glia contact lens symptoms questionnaire
Description
Change in total score (0-64)
Time Frame
21 days
Title
Fluorescein conjunctival staining
Description
Change in conjunctival staining (0-3 worst)
Time Frame
21 days
Title
Tear film examination by TearScan
Description
Change in total score (0-3 best)
Time Frame
60-80 minutes
Title
Tear film examination by TearScan
Description
Change in total score (0-3 best)
Time Frame
21 days
Title
Tear film breakup time
Description
Change in score (seconds)
Time Frame
60-80 minutes
Title
Tear film breakup time
Description
Change in score (seconds)
Time Frame
21 days
Title
Tear meniscus height
Description
Change in height (mm)
Time Frame
60-80 minutes
Title
Tear meniscus height
Description
Change in height (mm)
Time Frame
21 days
Title
Visual acuity
Description
Change in visual acuity
Time Frame
21 days
Title
Tear osmolarity
Description
Change in tear osmolarity (mOsm/L)
Time Frame
21 days
Title
Schirmer test
Description
Change in wetting length (mm)
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female of any race ≥18 years of age at Visit 1 Screening. Has provided verbal and written informed consent. Be able and willing to follow instructions, including participation in all study assessments and visits. Has been wearing soft contact lens in both eyes at least 2 days per week for at least a month. Duration of comfortable lens wear daily is less than desired. Suffers from at least two other symptoms while wearing lens with contact lens discomfort of grade 2 or higher: Dryness. Grittiness Blurred vision Itching Conjunctival redness Burning Stinging. Lens awareness Use of artificial tears or gels two or more times a day during contact lens wear hours. Berkeley Dry Eye Flow Chart (DEFC) score ≥3. Exclusion Criteria: BCVA at baseline <20/40. Wearing contact lens only in one eye. Wearers of the following contact lenses: Extended wear, prosthetic, scleral, and intracorneal gas permeable. Pregnant women or women of childbearing potential who are not using contraception. Diagnosis of the following autoimmune diseases: Addison's disease, Grave's disease, Hashimoto's thyroiditis, lupus, and Sjogren's syndrome. Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such dystrophies, infections, etc. 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. Has a known adverse reaction and/or sensitivity to either study drug or its components. Unwilling to remove contact lens overnight. Unwilling to attempt to wear contact lens seven (7) days a week during the study period. Plan to change brand of contact lens during study period. 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. Unwilling to discontinue swimming with immersed head for the duration of the study. Unwilling to withhold the use of artificial tears, gels, or wetting agents during periods when contact lens is worn during the study period. 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. Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng C. Lin, OD,PhD,FAAO
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Berkeley Clinical Research Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94720-2020
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel

We'll reach out to this number within 24 hrs