CompletedPhase 2

Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel

United States30 participantsStarted 2019-06-27

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

Hours of continuous comfortable contact lens wear

Timeframe: 21 days

Contact Lens Questionnaire-8 (CLDEQ-8)

Timeframe: 21 days

Berkeley Dry Eye Flow Chart

Timeframe: 21 days

Fluorescein corneal staining

Timeframe: 21 days

NCT IDNCT03994406

SponsorGlia, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-08-30

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.