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

• Status: Completed
• Trial end date: 2020-10-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ORA, Inc.
• Collaborator: Palatin Technologies
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

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