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Completed

NCT Number: NCT04268069

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

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

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Andover Eye Associates, Andover, Massachusetts, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PL9643 Ophthalmic Solution

Drug

PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks.

Placebo Ophthalmic Solution

Drug

Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

ORA, Inc.

Industry

Collaborators

  • Palatin Technologies, Inc

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 13, 2020
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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