Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel

NCT03994406 | Completed Phase 2 FDA Drug

• 1 other identifier: CLM-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Hours of continuous comfortable contact lens wear

  Change in total hours per day

  21 days

• Contact Lens Questionnaire-8 (CLDEQ-8)

  Change in total score (0-37 worst)

  21 days

• Berkeley Dry Eye Flow Chart

  Change in grade (1-5 worst)

  21 days

• Fluorescein corneal staining

  Change in score (0-3 worst)

  21 days

Secondary Outcomes (13)

• Eye discomfort from CLDEQ-8, frequency

  21 days

• Eye discomfort from CLDEQ-8, intensity

  21 days

• Glia contact lens symptoms questionnaire

  21 days

• Fluorescein conjunctival staining

  21 days

• Tear film examination by TearScan

  60-80 minutes

Study Arms (2)

CLM2 Topical Gel

EXPERIMENTAL

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

Drug: CLM2 topical gel

Placebo Topical Gel

PLACEBO COMPARATOR

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

Drug: Placebo topical gel

Interventions

CLM2 topical gel DRUG

Active topical gel for forehead dermal application

CLM2 Topical Gel

Placebo topical gel DRUG

Placebo topical gel for forehead dermal application

Placebo Topical Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Glia, LLC: lead

Study Sites (1)

UC Berkeley Clinical Research Center

Berkeley, California, 94720-2020, United States

Location

Study Officials

• Meng C. Lin, OD,PhD,FAAO

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 3-digit randomized number assignment with matching by age within 10 years, and within 5 years of lens wear. Study drug:placebo, 1:1.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1, study drug:placebo; block design.

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 21, 2019
• Study Start: June 27, 2019
• Primary Completion: August 30, 2019
• Study Completion: October 30, 2019
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)