CompletedPhase 2/3

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

United States101 participantsStarted 2018-08-15

Plain-language 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).

Who can participate

Age range22 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

What they're measuring

Number of Participants With the Left Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations

Timeframe: 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)

Number of Participants With the Right Nostril/Abnormal at 6 Months as Assessed by Intranasal Examinations

Timeframe: 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 6 months)

Number of Participants With the Left Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations

Timeframe: 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)

Number of Participants With the Right Nostril/Abnormal at 12 Months as Assessed by Intranasal Examinations

Timeframe: 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study (Visit 1 OPP-002 and 12 months)

Trial details

NCT IDNCT03920215

SponsorOyster Point Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09-20

Results submitted2021-09-10