Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel

Phase 2

Completed

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

• Registration Number: NCT03994406
• Lead Sponsor: Glia, LLC

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.

Study Timeline

• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-06-20
• Study First Posted: 2019-06-21
• Study Start: 2019-06-27
• Primary Completion: 2019-08-30
• Study Completion: 2019-10-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CLM2 Topical Gel	CLM2 topical gel	CLM2 topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime.
Placebo Topical Gel	Placebo topical gel	Placebo topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime.

Primary Outcome Measures

Name	Time	Method
Fluorescein corneal staining	21 days	Change in score (0-3 worst)
Berkeley Dry Eye Flow Chart	21 days	Change in grade (1-5 worst)
Hours of continuous comfortable contact lens wear	21 days	Change in total hours per day
Contact Lens Questionnaire-8 (CLDEQ-8)	21 days	Change in total score (0-37 worst)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UC Berkeley Clinical Research Center; 🇺🇸 Berkeley, California, United States