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

Oyster Point Pharma

Status and phase: Completed; Phase 3; Phase 2

Conditions: Long Term Follow up Dry Eye Disease

Treatments: Drug: OC-01 Low Dose, 0.12 mg/mL; Drug: OC-01 Mid Dose, 0.6 mg/mL; Drug: OC-01 High Dose, 1.2 mg/mL; Drug: Placebo (vehicle) nasal spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT03920215

OPP-002-01EXT

Details and patient eligibility

About

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).

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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 criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 4 patient groups, including a placebo group

OC-01 Low Dose, 0.12 mg/mL

Active Comparator group

Description:

OC-01 (varenicline) nasal spray, 0.12 mg/mL

Treatment:

Drug: OC-01 Low Dose, 0.12 mg/mL

OC-01 Mid Dose, 0.6 mg/mL

Active Comparator group

Description:

OC-01 (varenicline) nasal spray, 0.60 mg/mL

Treatment:

Drug: OC-01 Mid Dose, 0.6 mg/mL

OC-01 High Dose, 1.2 mg/mL

Active Comparator group

Description:

OC-01 (varenicline) nasal spray, 1.2 mg/mL

Treatment:

Drug: OC-01 High Dose, 1.2 mg/mL

Placebo (vehicle) nasal spray

Placebo Comparator group

Description:

Placebo (vehicle) nasal spray

Treatment:

Drug: Placebo (vehicle) nasal spray