Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel

March 23, 2023 updated by: Glia, LLC

A Controlled Phase 2 Study for Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94720-2020
        • UC Berkeley Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hours of continuous comfortable contact lens wear
Time Frame: 21 days
Change in total hours per day
21 days
Contact Lens Questionnaire-8 (CLDEQ-8)
Time Frame: 21 days
Change in total score (0-37 worst)
21 days
Berkeley Dry Eye Flow Chart
Time Frame: 21 days
Change in grade (1-5 worst)
21 days
Fluorescein corneal staining
Time Frame: 21 days
Change in score (0-3 worst)
21 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Eye discomfort from CLDEQ-8, frequency
Time Frame: 21 days
Change in score (0-4 worst)
21 days
Eye discomfort from CLDEQ-8, intensity
Time Frame: 21 days
Change in score (0-5 worst)
21 days
Glia contact lens symptoms questionnaire
Time Frame: 21 days
Change in total score (0-64)
21 days
Fluorescein conjunctival staining
Time Frame: 21 days
Change in conjunctival staining (0-3 worst)
21 days
Tear film examination by TearScan
Time Frame: 60-80 minutes
Change in total score (0-3 best)
60-80 minutes
Tear film examination by TearScan
Time Frame: 21 days
Change in total score (0-3 best)
21 days
Tear film breakup time
Time Frame: 60-80 minutes
Change in score (seconds)
60-80 minutes
Tear film breakup time
Time Frame: 21 days
Change in score (seconds)
21 days
Tear meniscus height
Time Frame: 60-80 minutes
Change in height (mm)
60-80 minutes
Tear meniscus height
Time Frame: 21 days
Change in height (mm)
21 days
Visual acuity
Time Frame: 21 days
Change in visual acuity
21 days
Tear osmolarity
Time Frame: 21 days
Change in tear osmolarity (mOsm/L)
21 days
Schirmer test
Time Frame: 21 days
Change in wetting length (mm)
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Glia, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meng C. Lin, OD,PhD,FAAO, University of California, Berkeley

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLM-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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