Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye

• Sponsor: ORA, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04268069
• Collaborator: Palatin Technologies, Inc (Industry)
• Enrollment: 160
• Locations: 4
• Arms: 2
• Actual Duration (Months): 7.7
• Patients Per Site: 40
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

Evaluation of safety and efficacy of PL9643 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: PL9643 Ophthalmic Solution; Drug: Placebo Ophthalmic Solution	Phase 2

Detailed Description

The clinical trial is a Phase 2, multi center, randomized, double masked and placebo controlled study.

During a 14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive Placebo Ophthalmic Solution (vehicle) bilaterally. During the screening period, exposure to the CAE® will be conducted to ascertain eligibility to enter the study at Visit 1 and Visit 2. Those who qualify at Visit 2 will be randomized to receive study drug in a double-masked fashion for 12 weeks. The CAE® exposure will occur at all Visits.

Study Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multi-center, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of PL9643 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye
• Actual Study Start Date: Feb 14, 2020
• Actual Primary Completion Date: Oct 5, 2020
• Actual Study Completion Date: Oct 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Ophthalmic Solution (vehicle) vehicle	Drug: Placebo Ophthalmic Solution; Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks.
Active Comparator: PL9643 Ophthalmic Solution PL9643 Ophthalmic Solution	Drug: PL9643 Ophthalmic Solution; PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks.

Outcome Measures

Primary Outcome Measures

1. Inferior Corneal Fluorescein Staining Using The Ora Calibra Scale [Day 85]

   An assessment of corneal fluorescein staining using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)

2. Ocular Discomfort Using The Ora Calibra Scale [Day 85]

   A patient-reported subjective assessment of ocular discomfort using the 0 [none] to 4 [worst] Ora Calibra Scale recorded at each study visit throughout the treatment period

Secondary Outcome Measures

1. Corneal Fluorescein Staining Using The Ora Calibra Scale [12 weeks]

   An assessment of corneal fluorescein staining using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)

2. Conjunctival Lissamine Green Staining Using The Ora Calibra Scale [12 weeks]

   An assessment of conjunctival lissamine green staining using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)

3. Conjunctival Redness Using The Ora Calibra Scale [12 weeks]

   An assessment of conjunctival redness using the 0 [none] to 4 [worst] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Be at least 18 years of age.

• Provided written informed consent.

• Have a reported history of dry eye

• Have a history of use or desire to use eye drops for dry eye symptoms

• Have corrected visual acuity greater than or equal to +0.7 in both eyes

Exclusion Criteria:

• Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal)

• Have any planned ocular and/or lid surgeries over the study period.

• Have an uncontrolled systemic disease.

• Be a woman who is pregnant, nursing or planning a pregnancy.

• Be a woman of childbearing potential who is not using an acceptable means of birth control

• Have a known allergy and/or sensitivity to the test article or its components.

• Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

• Have used an investigational drug or device within 30 days of Visit 1

• Be unable or unwilling to follow instructions, including participation in all study assessments and visits

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Andover Eye Associates	Andover	Massachusetts	United States	01810
2	Andover Eye Associates	Raynham	Massachusetts	United States	02767
3	Vita Eye Clinc	Shelby	North Carolina	United States	28150
4	Total Eye Care, P.A.	Memphis	Tennessee	United States	38119

Sponsors and Collaborators

• ORA, Inc.
• Palatin Technologies, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ORA, Inc.
• ClinicalTrials.gov Identifier: NCT04268069
• Other Study ID Numbers: PL9643-201
• First Posted: Feb 13, 2020
• Last Update Posted: Nov 13, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

No Results Posted as of Nov 13, 2020