Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04268069
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04268069
Recruitment Status : Active, not recruiting
First Posted : February 13, 2020
Last Update Posted : August 5, 2020
Sponsor:
Collaborator:
Palatin Technologies
Information provided by (Responsible Party):
ORA, Inc.

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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 : February 14, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

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.




Primary Outcome Measures :
  1. Inferior Corneal Fluorescein Staining Using The Ora Calibra Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268069


Locations
Layout table for location information
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Andover Eye Associates
Raynham, Massachusetts, United States, 02767
United States, North Carolina
Vita Eye Clinc
Shelby, North Carolina, United States, 28150
United States, Tennessee
Total Eye Care, P.A.
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
ORA, Inc.
Palatin Technologies
Layout table for additonal information
Responsible Party: ORA, Inc.
ClinicalTrials.gov Identifier: NCT04268069    
Other Study ID Numbers: PL9643-201
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions