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

Dry Eye Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04884217
• Other study ID #: DE-2
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: May 20, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: May 2021
• Source: PharmaDax Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Pro-ocular™ Topical Gel
Pro-ocular™ Topical Gel 1% is applied dermally to the forehead twice-daily
• Placebo Topical Gel
Placebo is a toopical gel without active ingredient applied dermally to the forehead twice-daily

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital, National Defense Medical Center	Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
PharmaDax Inc.	Glia, LLC

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score	Change from baseline in SANDE symptoms frequency score (0-100 worst)	2 weeks
Primary	Change in corneal (central) fluorescein staining score	Change from baseline in score on a visual analog scale (0-10 worst)	4 weeks
Secondary	Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score	Change from baseline in SANDE symptoms global score (0-100 worst)	2 weeks
Secondary	Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score	Change from baseline in SANDE symptoms global score (0-100 worst)	4 weeks
Secondary	Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score	Change from baseline in SANDE symptoms global score (0-100 worst)	8 weeks
Secondary	Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score	Change from baseline in SANDE symptoms global score (0-100 worst)	12 weeks
Secondary	Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score	Change from baseline in SANDE symptoms frequency score (0-100 worst)	4 weeks
Secondary	Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score	Change from baseline in SANDE symptoms frequency score (0-100 worst)	8 weeks
Secondary	Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score	Change from baseline in SANDE symptoms frequency score (0-100 worst)	12 weeks
Secondary	Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score	Change from baseline in SANDE symptoms severity score (0-100 worst)	2 weeks
Secondary	Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score	Change from baseline in SANDE symptoms severity score (0-100 worst)	4 weeks
Secondary	Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score	Change from baseline in SANDE symptoms severity score (0-100 worst)	8 weeks
Secondary	Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Severity score	Change from baseline in SANDE symptoms severity score (0-100 worst)	12 weeks
Secondary	Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score	Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)	1 hour
Secondary	Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score	Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)	2 weeks
Secondary	Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score	Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)	4 weeks
Secondary	Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score	Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)	8 weeks
Secondary	Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) ocular discomfort score	Change from baseline in GLIA OSDSQ ocular discomfort score (0-10 worst)	12 weeks
Secondary	Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores	Change from baseline in GLIA OSDSQ sum of scores (highest worst)	1 hour
Secondary	Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores	Change from baseline in GLIA OSDSQ sum of scores (highest worst)	2 weeks
Secondary	Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores	Change from baseline in GLIA OSDSQ sum of scores (highest worst)	4 weeks
Secondary	Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores	Change from baseline in GLIA OSDSQ sum of scores (highest worst)	8 weeks
Secondary	Change in GLIA (Ocular Surface Disease Symptoms Questionnaire) sum of scores	Change from baseline in GLIA OSDSQ sum of scores (highest worst)	12 weeks
Secondary	Change in Tear Film Grading by TearScan examination	Change from baseline in tear film grade (0-3 best)	1 hour
Secondary	Change in Tear Film Grading by TearScan examination	Change from baseline in tear film grade (0-3 best)	2 weeks
Secondary	Change in Tear Film Grading by TearScan examination	Change from baseline in tear film grade (0-3 best)	4 weeks
Secondary	Change in Tear Film Grading by TearScan examination	Change from baseline in tear film grade (0-3 best)	8 weeks
Secondary	Change in Tear Film Grading by TearScan examination	Change from baseline in tear film grade (0-3 best)	12 weeks
Secondary	Change in Meibography score by Keratograph®	Change from baseline using Grades 0 to 3 (0 no loss to 3 >2/3 loss)	12 weeks
Secondary	Change in Tear Meniscus Height (TMH) by Keratograph®	Change from baseline in mm TMH (higher is better)	1 hour
Secondary	Change in Tear Meniscus Height (TMH) by Keratograph®	Change from baseline in mm TMH (higher is better)	4 weeks
Secondary	Change in Tear Meniscus Height (TMH) by Keratograph®	Change from baseline in mm TMH (higher is better)	8 weeks
Secondary	Change in Tear Meniscus Height (TMH) by Keratograph®	Change from baseline in mm TMH (higher is better)	12 weeks
Secondary	Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)	Change from baseline in NIKBUT in seconds (longer is better)	1 hour
Secondary	Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)	Change from baseline in NIKBUT in seconds (longer is better)	4 weeks
Secondary	Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)	Change from baseline in NIKBUT in seconds (longer is better)	8 weeks
Secondary	Change in Non-Invasive Keratograph® Tear Break-Up Time (NIKBUT)	Change from baseline in NIKBUT in seconds (longer is better)	12 weeks
Secondary	Change in Bulbar redness score by Keratograph®	Change from baseline in Bulbar redness score (highest is worst)	1 hour
Secondary	Change in Bulbar redness score by Keratograph®	Change from baseline in Bulbar redness score (highest is worst)	4 weeks
Secondary	Change in Bulbar redness score by Keratograph®	Change from baseline in Bulbar redness score (highest is worst)	8 weeks
Secondary	Change in Bulbar redness score by Keratograph®	Change from baseline in Bulbar redness score (highest is worst)	12 weeks
Secondary	Change in tear film osmolarity by TearLab™ osmolarity system	Change from baseline in mOsms/L (higher value is worse)	1 hour
Secondary	Change in tear film osmolarity by TearLab™ osmolarity system	Change from baseline in mOsms/L (higher value is less sensitive)	2 weeks
Secondary	Change in corneal sensitivity using Cochet-Bonnet esthesiometer	Change from baseline in mm Hg (higher is less sensitive)	1 hour
Secondary	Change in corneal sensitivity using Cochet-Bonnet esthesiometer	Change from baseline in mm Hg (higher is less sensitive)	2 weeks
Secondary	Change in corneal sensitivity using Cochet-Bonnet esthesiometer	Change from baseline in mm Hg (higher is less sensitive)	4 weeks
Secondary	Change in corneal sensitivity using Cochet-Bonnet esthesiometer	Change from baseline in mm Hg (higher is less sensitive)	8 weeks
Secondary	Change in corneal sensitivity using Cochet-Bonnet esthesiometer	Change from baseline in mm Hg (higher is less sensitive)	12 weeks
Secondary	Change in Fluorescein Tear Break-Up Time (FBUT)	Change from baseline in FBUT in seconds (longer is better)	1 hour
Secondary	Change in Fluorescein Tear Break-Up Time (FBUT)	Change from baseline in FBUT in seconds (longer is better)	4 weeks
Secondary	Change in Fluorescein Tear Break-Up Time (FBUT)	Change from baseline in FBUT in seconds (longer is better)	8 weeks
Secondary	Change in Fluorescein Tear Break-Up Time (FBUT)	Change from baseline in FBUT in seconds (longer is better)	12 weeks
Secondary	Change in corneal (central) fluorescein staining score	Change from baseline in central corneal fluorescein staining score (0-10 worst)	2 weeks
Secondary	Change in corneal (central) fluorescein staining score	Change from baseline in central corneal fluorescein staining score (0-10 worst)	8 weeks
Secondary	Change in corneal (central) fluorescein staining score	Change from baseline in central corneal fluorescein staining score (0-10 worst)	12 weeks
Secondary	Change in corneal (inferior) fluorescein staining score	Change from baseline in inferior corneal fluorescein staining score (0-10 worst)	2 weeks
Secondary	Change in corneal (inferior) fluorescein staining score	Change from baseline in inferior corneal fluorescein staining score (0-10 worst)	4 weeks
Secondary	Change in corneal (inferior) fluorescein staining score	Change from baseline in inferior corneal fluorescein staining score (0-10 worst)	8 weeks
Secondary	Change in corneal (inferior) fluorescein staining score	Change from baseline in inferior corneal fluorescein staining score (0-10 worst)	12 weeks
Secondary	Change in corneal (superior) fluorescein staining score	Change from baseline in superior corneal fluorescein staining score (0-10 worst)	2 weeks
Secondary	Change in corneal (superior) fluorescein staining score	Change from baseline in superior corneal fluorescein staining score (0-10 worst)	4 weeks
Secondary	Change in corneal (superior) fluorescein staining score	Change from baseline in superior corneal fluorescein staining score (0-10 worst)	8 weeks
Secondary	Change in corneal (superior) fluorescein staining score	Change from baseline in superior corneal fluorescein staining score (0-10 worst)	12 weeks
Secondary	Change in corneal fluorescein staining sum of scores	Change from baseline in corneal fluorescein staining sum of scores (0-30 worst)	2 weeks
Secondary	Change in corneal fluorescein staining sum of scores	Change from baseline in corneal fluorescein staining sum of scores (0-30 worst)	4 weeks
Secondary	Change in corneal fluorescein staining sum of scores	Change from baseline in corneal fluorescein staining sum of scores (0-30 worst)	8 weeks
Secondary	Change in corneal fluorescein staining sum of scores	Change from baseline in corneal fluorescein staining sum of scores (0-30 worst)	12 weeks
Secondary	Change in conjunctival fluorescein staining sum of scores	Change from baseline in conjunctival fluorescein staining sum of scores (0-30 worst)	2 weeks
Secondary	Change in conjunctival fluorescein staining sum of scores	Change from baseline in conjunctival fluorescein staining sum of scores (0-30 worst)	4 weeks
Secondary	Change in conjunctival fluorescein staining sum of scores	Change from baseline in conjunctival fluorescein staining sum of scores (0-30 worst)	8 weeks
Secondary	Change in conjunctival fluorescein staining sum of scores	Change from baseline in conjunctival fluorescein staining sum of scores (0-30 worst)	12 weeks
Secondary	Change in lissamine green staining (corneal and conjunctival) sum of scores	Change from baseline in lissamine green staining (corneal and conjunctival) sum of scores	2 weeks
Secondary	Change in lissamine green staining (corneal and conjunctival) sum of scores	Change from baseline in lissamine green staining (corneal and conjunctival) sum of scores (higher is worse)	4 weeks
Secondary	Change in lissamine green staining (corneal and conjunctival) sum of scores	Change from baseline in lissamine green staining (corneal and conjunctival) sum of scores (higher is worse)	8 weeks
Secondary	Change in lissamine green staining (corneal and conjunctival) sum of scores	Change from baseline in lissamine green staining (corneal and conjunctival) sum of scores (higher is worse)	12 weeks
Secondary	Change in conjunctival hyperemia (by slit lamp biomicroscopy)	Change from baseline in conjunctival hyperemia score (0-10 worst)	2 weeks
Secondary	Change in conjunctival hyperemia (by slit lamp biomicroscopy)	Change from baseline in conjunctival hyperemia score (0-10 worst)	4 weeks
Secondary	Change in conjunctival hyperemia (by slit lamp biomicroscopy)	Change from baseline in conjunctival hyperemia score (0-10 worst)	8 weeks
Secondary	Change in conjunctival hyperemia (by slit lamp biomicroscopy)	Change from baseline in conjunctival hyperemia score (0-10 worst)	12 weeks