NCT04762355

Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Palovarotene Ophthalmic Solution in Healthy Adult Subjects

A Phase 1, Double-Masked, Vehicle-Controlled Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Palovarotene Ophthalmic Solution in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Clementia Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Dry eye disease (DED) is a keratoconjunctive disorder that "is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. The goal of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple ascending doses of palovarotene ophthalmic solution in healthy adult subjects.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	Palovarotene	ophthalmic solution in different concentrations: Dose 1, Dose 2 and Dose 3
DRUG	Vehicle	Placebo-to-match palovarotene ophthalmic solution vials

Timeline

• Start date: 2018-08-30
• Primary completion: 2019-01-03
• Completion: 2019-01-03
• First posted: 2021-02-21
• Last updated: 2021-02-21

Locations

1 site across 1 country: Canada