Clinical trial NCT04884217: Treatment of Dry Eye Disease Using Pro-ocular™ - A Proof of Concept, Safety, and Efficacy Study
Official title: Treatment of Dry Eye Disease Using Pro-ocular™ - A Proof of Concept, Safety, and Efficacy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Dry Eye Syndrome
Keratoconjunctivitis Sicca
Keywords: Dry Eye
Dry Eye Disease
Evaporative Dry Eye
Evaporative Dry Eye Disease
Keratoconjuncitivitis Sicca
Sjogren's Sydrome
Lead sponsor: PharmaDax Inc.
Sponsor class: INDUSTRY
Collaborators: name: Glia, LLC
First posted: 2021-05-12
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score
timeFrame: 2 weeks
measure: Change in corneal (central) fluorescein staining score
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score
timeFrame: 2 weeks
measure: Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score
timeFrame: 4 weeks
measure: Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score
timeFrame: 8 weeks
measure: Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score
timeFrame: 12 weeks
measure: Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score
timeFrame: 4 weeks
measure: Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score
timeFrame: 8 weeks
measure: Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score
timeFrame: 12 weeks
measure: Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score
timeFrame: 2 weeks
measure: Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score
timeFrame: 4 weeks
measure: Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score
timeFrame: 8 weeks
measure: Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score
timeFrame: 12 weeks
measure: Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score
timeFrame: 1 hour
measure: Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score
timeFrame: 2 weeks
measure: Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score
timeFrame: 4 weeks
measure: Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score
timeFrame: 8 weeks
measure: Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score
timeFrame: 12 weeks
measure: Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores
timeFrame: 1 hour
measure: Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores
timeFrame: 2 weeks
measure: Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores
timeFrame: 4 weeks
measure: Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores
timeFrame: 8 weeks
measure: Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores
timeFrame: 12 weeks
measure: Change in Tear Film Grading by TearScan examination
timeFrame: 1 hour
measure: Change in Tear Film Grading by TearScan examination
timeFrame: 2 weeks
measure: Change in Tear Film Grading by TearScan examination
timeFrame: 4 weeks
measure: Change in Tear Film Grading by TearScan examination
timeFrame: 8 weeks
measure: Change in Tear Film Grading by TearScan examination
timeFrame: 12 weeks
measure: Change in Meibography score by Keratograph®
timeFrame: 12 weeks
measure: Change in Tear Meniscus Height (TMH) by Keratograph®
timeFrame: 1 hour
measure: Change in Tear Meniscus Height (TMH) by Keratograph®
timeFrame: 4 weeks
measure: Change in Tear Meniscus Height (TMH) by Keratograph®
timeFrame: 8 weeks
measure: Change in Tear Meniscus Height (TMH) by Keratograph®
timeFrame: 12 weeks
measure: Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)
timeFrame: 1 hour
measure: Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)
timeFrame: 4 weeks
measure: Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)
timeFrame: 8 weeks
measure: Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)
timeFrame: 12 weeks
measure: Change in Bulbar redness score by Keratograph®
timeFrame: 1 hour
measure: Change in Bulbar redness score by Keratograph®
timeFrame: 4 weeks
measure: Change in Bulbar redness score by Keratograph®
timeFrame: 8 weeks
measure: Change in Bulbar redness score by Keratograph®
timeFrame: 12 weeks
measure: Change in tear film osmolarity by TearLab™ osmolarity system
timeFrame: 1 hour
measure: Change in tear film osmolarity by TearLab™ osmolarity system
timeFrame: 2 weeks
measure: Change in corneal sensitivity using Cochet-Bonnet esthesiometer
timeFrame: 1 hour
measure: Change in corneal sensitivity using Cochet-Bonnet esthesiometer
timeFrame: 2 weeks
measure: Change in corneal sensitivity using Cochet-Bonnet esthesiometer
timeFrame: 4 weeks
measure: Change in corneal sensitivity using Cochet-Bonnet esthesiometer
timeFrame: 8 weeks
measure: Change in corneal sensitivity using Cochet-Bonnet esthesiometer
timeFrame: 12 weeks
measure: Change in Fluorescein Tear Break-Up Time (FBUT)
timeFrame: 1 hour
measure: Change in Fluorescein Tear Break-Up Time (FBUT)
timeFrame: 4 weeks
measure: Change in Fluorescein Tear Break-Up Time (FBUT)
timeFrame: 8 weeks
measure: Change in Fluorescein Tear Break-Up Time (FBUT)
timeFrame: 12 weeks
measure: Change in corneal (central) fluorescein staining score
timeFrame: 2 weeks
measure: Change in corneal (central) fluorescein staining score
timeFrame: 8 weeks
measure: Change in corneal (central) fluorescein staining score
timeFrame: 12 weeks
measure: Change in corneal (inferior) fluorescein staining score
timeFrame: 2 weeks
measure: Change in corneal (inferior) fluorescein staining score
timeFrame: 4 weeks
measure: Change in corneal (inferior) fluorescein staining score
timeFrame: 8 weeks
measure: Change in corneal (inferior) fluorescein staining score
timeFrame: 12 weeks
measure: Change in corneal (superior) fluorescein staining score
timeFrame: 2 weeks
measure: Change in corneal (superior) fluorescein staining score
timeFrame: 4 weeks
measure: Change in corneal (superior) fluorescein staining score
timeFrame: 8 weeks
measure: Change in corneal (superior) fluorescein staining score
timeFrame: 12 weeks
measure: Change in corneal fluorescein staining sum of scores
timeFrame: 2 weeks
measure: Change in corneal fluorescein staining sum of scores
timeFrame: 4 weeks
measure: Change in corneal fluorescein staining sum of scores
timeFrame: 8 weeks
measure: Change in corneal fluorescein staining sum of scores
timeFrame: 12 weeks
measure: Change in conjunctival fluorescein staining sum of scores
timeFrame: 2 weeks
measure: Change in conjunctival fluorescein staining sum of scores
timeFrame: 4 weeks
measure: Change in conjunctival fluorescein staining sum of scores
timeFrame: 8 weeks
measure: Change in conjunctival fluorescein staining sum of scores
timeFrame: 12 weeks
measure: Change in lissamine green staining (corneal and conjunctival) sum of scores
timeFrame: 2 weeks
measure: Change in lissamine green staining (corneal and conjunctival) sum of scores
timeFrame: 4 weeks
measure: Change in lissamine green staining (corneal and conjunctival) sum of scores
timeFrame: 8 weeks
measure: Change in lissamine green staining (corneal and conjunctival) sum of scores
timeFrame: 12 weeks
measure: Change in conjunctival hyperemia (by slit lamp biomicroscopy)
timeFrame: 2 weeks
measure: Change in conjunctival hyperemia (by slit lamp biomicroscopy)
timeFrame: 4 weeks
measure: Change in conjunctival hyperemia (by slit lamp biomicroscopy)
timeFrame: 8 weeks
measure: Change in conjunctival hyperemia (by slit lamp biomicroscopy)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital, National Defense Medical Center
Study officials:
affiliation: PharmaDax Inc.
name: Peichun Kuo
role: STUDY_DIRECTOR
References: