Evaluation of the Long Term Follow up of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease

Last updated: October 30, 2023
Sponsor: Oyster Point Pharma, Inc.
Overall Status: Completed

Phase

2/3

Condition

Sjogren's Syndrome

Dry Eyes

Eyelid Inflammation

Treatment

OC-01 Low Dose, 0.12 mg/mL

Placebo (vehicle) nasal spray

OC-01 High Dose, 1.2 mg/mL

Clinical Study ID

NCT03920215
OPP-002-01EXT
  • Ages > 22
  • All Genders

Study Summary

The objective of this safety long-term follow-up study was to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study (NCT03636061).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Have been enrolled in the OPP-002 study
  2. Have received at least one dose of the study drug/placebo in OPP-002 study
  3. Completed the OPP-002 study to Visit 5
  4. Have provided verbal and written informed consent

Exclusion

Exclusion Criteria:

  1. Have discontinued prior to Visit 5 in the OPP-002 study.

Study Design

Total Participants: 101
Treatment Group(s): 4
Primary Treatment: OC-01 Low Dose, 0.12 mg/mL
Phase: 2/3
Study Start date:
August 15, 2018
Estimated Completion Date:
September 20, 2019

Study Description

Study OPP-002-01 was a long-term follow-up study of those subjects who had previously participated in the OPP-002 study (NCT03636061). The OPP-002 study is a Phase 2, multicenter, randomized, double-masked, placebo-controlled study designed to evaluate the safety and efficacy of OC-01 nasal spray in adult participants with dry eye disease.

The first scheduled visit occurs 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study. The second scheduled visit occurs 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.

Connect with a study center

  • Newport Beach

    Newport Beach, California 92663
    United States

    Site Not Available

  • Indianapolis

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • Andover

    Andover, Massachusetts 01810
    United States

    Site Not Available

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