Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye
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ClinicalTrials.gov Identifier: NCT04268069 |
Recruitment Status :
Completed
First Posted : February 13, 2020
Last Update Posted : November 13, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dry Eye Disease | Drug: PL9643 Ophthalmic Solution Drug: Placebo Ophthalmic Solution | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
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 : | February 14, 2020 |
Actual Primary Completion Date : | October 5, 2020 |
Actual Study Completion Date : | October 5, 2020 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo Ophthalmic Solution (vehicle)
vehicle
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Drug: Placebo Ophthalmic Solution
Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks. |
Active Comparator: PL9643 Ophthalmic Solution
PL9643 Ophthalmic Solution
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Drug: PL9643 Ophthalmic Solution
PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks. |
- 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)
- 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
- 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)
- 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)
- 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)

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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
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 |
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: | November 13, 2020 |
Last Verified: | November 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Dry Eye Syndromes Keratoconjunctivitis Sicca Eye Diseases Lacrimal Apparatus Diseases Keratoconjunctivitis Conjunctivitis |
Conjunctival Diseases Keratitis Corneal Diseases Pharmaceutical Solutions Ophthalmic Solutions |