Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel

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

Detailed Description
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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.

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

Conditions
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Contact Lens Discomfort, Contact Lens-induced Corneal Disorder, Contact Lens Acute Red Eye, Contact Lens-induced Corneal Fluorescein Staining

Intervention / Treatment
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* Drug: CLM2 topical gel
* Drug: Placebo topical gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1, study drug:placebo; block design.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLM2 Topical Gel<br>CLM2 topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime. | Drug: CLM2 topical gel<br>* Active topical gel for forehead dermal application<br>|
| Placebo Comparator: Placebo Topical Gel<br>Placebo topical gel to be applied dermally to forehead twice daily, in the morning and at bedtime. | Drug: Placebo topical gel<br>* Placebo topical gel for forehead dermal application<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lens, ocular erythema, contact lens discomfort