Treatment of Dry Eye Disease Using Pro-ocular™ - A Proof of Concept, Safety, and Efficacy Study

PharmaDax Inc.80 enrolled

Overview

To evaluate the safety and efficacy of 1% Pro-ocular topical gel administered twice daily for 12 weeks in treatment of Dry Eye Disease

Pro-ocular™ 1% topical gel his demonstrated efficacy in rapidly reducing or eliminating dry eye symptoms, and after multiple doses, the signs and symptoms of ocular surface disease including dry eye disease. Study DE-2 is single center, randomized, double-masked, placebo-controlled, parallel-group study designed to evaluate the safety and efficacy of 1% Pro-ocular topical gel administered twice daily for 12 weeks for treatment of Dry Eye Disease. The approximately 80 subjects will be randomized 1:1, active drug:placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Dry Eye Syndrome Keratoconjunctivitis Sicca

Interventions

Pro-ocular™ Topical GelDRUG

Pro-ocular™ Topical Gel 1% is applied dermally to the forehead twice-daily

Placebo Topical GelDRUG

Placebo is a toopical gel without active ingredient applied dermally to the forehead twice-daily

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female of any race, at least 20 years of age at Visit 1 Screening. 2. Has a subject reported history (including physician diagnosis) of dry eye disease in both eyes for at least 3 months prior to Visit 1. 3. Has SANDE score ≥50 in either frequency or severity of symptoms of dryness and/or irritation at Visit 1. 4. Have all of the following in the same eye at Visit 1: 1. Fluorescein Tear Break-Up Time of ≤5 seconds. 2. Corneal fluorescein staining score of moderate or more in any field (inferior, superior or central). 3. Report a severity score of moderate or more on ocular dryness and at least one of the other symptoms on the GLIA Ocular Surface Disease Symptoms Questionnaire. 5. Has provided written informed consent. 6. Be able and willing to follow oral and written instructions, including participation in all study assessments and visits. Exclusion Criteria: 1. Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as but not limited to corneal opacities and scars, dystrophies, epithelial scarring, infections, history of blood clots, etc. 2. Has infections, or inflammatory skin lesion in or around the dosing area. 3. Best corrected visual acuity baseline \<20/200. 4. Has a condition or history that, in the opinion of the investigator, may interfere significantly with the subject's participation in the study. 5. Wear contact lens within 7 days prior to Visit 1. 6. Anticipate change of vision correction or anticipate any ocular procedures during study period. 7. A woman who is pregnant or testing positive in the blood pregnancy test at screening, nursing an infant, or planning a pregnancy. 8. Has a known adverse reaction and/or sensitivity to the study drug or its components. 9. Use of topical ocular cyclosporine (e.g. Restasis®), lifitegrast (Xiidra®), diquafosol (Diquas®), eye gels, eye ointments, any administration route of steroids, anti-histamines, antipsychotics, antidepressants and NSAIDs within 30 days prior to Visit 1. 10. Routine use (more than once a week) of a chlorinated swimming pool during study period. 11. Unwilling or unable to cease using the following medications during the study period (from Visit 1 to Visit 6): Topical ocular cyclosporine (e.g. Restasis®), lifitegrast (Xiidra®), diquafosol (Diquas®), eye gels, eye ointments, any administration route of steroids, anti-histamines, antipsychotics, antidepressants and NSAIDs.. 12. Unwilling to cease the use of sunscreen and face scrubs on the forehead or eye area during study period. 13. Smoke within 3 months prior to Visit 1. 14. Ongoing glaucoma treatment within 30 days prior to Visit 1 and during study period. 15. Currently enrolled in an investigational drug or device study within 30 days prior to Visit 1 and during study period.

Locations (1)

Tri-Service General Hospital, National Defense Medical Center

Taipei, Taiwan

Outcomes

Primary Outcomes

Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score

Change from baseline in SANDE symptoms frequency score (0-100 worst)

Time frame: 2 weeks

Change in corneal (central) fluorescein staining score

Change from baseline in score on a visual analog scale (0-10 worst)

Time frame: 4 weeks

Secondary Outcomes

Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score

Change from baseline in SANDE symptoms global score (0-100 worst)

Time frame: 2 weeks

Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score

Change from baseline in SANDE symptoms global score (0-100 worst)

Time frame: 4 weeks

Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score

Change from baseline in SANDE symptoms global score (0-100 worst)

Time frame: 8 weeks

Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score

Change from baseline in SANDE symptoms global score (0-100 worst)

Time frame: 12 weeks

Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score

Change from baseline in SANDE symptoms frequency score (0-100 worst)

Time frame: 4 weeks

Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score

Data from ClinicalTrials.gov

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Change from baseline in SANDE symptoms frequency score (0-100 worst)

Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score

Change from baseline in SANDE symptoms frequency score (0-100 worst)

Time frame: 12 weeks

Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score

Change from baseline in SANDE symptoms severity score (0-100 worst)

Time frame: 2 weeks

Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score

Change from baseline in SANDE symptoms severity score (0-100 worst)

Time frame: 4 weeks

Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score

Change from baseline in SANDE symptoms severity score (0-100 worst)

Time frame: 8 weeks

Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score

Change from baseline in SANDE symptoms severity score (0-100 worst)

Time frame: 12 weeks

Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score

Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)

Time frame: 1 hour

Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score

Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)

Time frame: 2 weeks

Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score

Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)

Time frame: 4 weeks

Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score

Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)

Time frame: 8 weeks

Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score

Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)

Time frame: 12 weeks

Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores

Change from baseline in GLIA OSDSQ sum of scores (highest worst)

Time frame: 1 hour

Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores

Change from baseline in GLIA OSDSQ sum of scores (highest worst)

Time frame: 2 weeks

Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores

Change from baseline in GLIA OSDSQ sum of scores (highest worst)

Time frame: 4 weeks

Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores

Change from baseline in GLIA OSDSQ sum of scores (highest worst)

Time frame: 8 weeks

Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores

Change from baseline in GLIA OSDSQ sum of scores (highest worst)

Time frame: 12 weeks