Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel

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: Completed
• Conditions: Contact Lens Discomfort; Contact Lens-induced Corneal Disorder; Contact Lens Acute Red Eye; Contact Lens-induced Corneal Fluorescein Staining
• Intervention / Treatment: Drug: CLM2 topical gel; Drug: Placebo topical gel

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: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eye discomfort from CLDEQ-8, frequency	Change in score (0-4 worst)	21 days
Eye discomfort from CLDEQ-8, intensity	Change in score (0-5 worst)	21 days
Glia contact lens symptoms questionnaire	Change in total score (0-64)	21 days
Fluorescein conjunctival staining	Change in conjunctival staining (0-3 worst)	21 days
Tear film examination by TearScan	Change in total score (0-3 best)	60-80 minutes
Tear film examination by TearScan	Change in total score (0-3 best)	21 days
Tear film breakup time	Change in score (seconds)	60-80 minutes
Tear film breakup time	Change in score (seconds)	21 days
Tear meniscus height	Change in height (mm)	60-80 minutes
Tear meniscus height	Change in height (mm)	21 days
Visual acuity	Change in visual acuity	21 days
Tear osmolarity	Change in tear osmolarity (mOsm/L)	21 days
Schirmer test	Change in wetting length (mm)	21 days

Collaborators and Investigators

• Sponsor: Glia, LLC
• Investigators: Principal Investigator: Meng C. Lin, OD,PhD,FAAO, University of California, Berkeley

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: contact lens; ocular erythema; contact lens discomfort
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases
• Other Study ID 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