NCT03688802 is a Phase 2 clinical trial of OC-01 (varenicline) nasal spray in Dry Eye Disease, sponsored by Oyster Point Pharma, Inc..

Who is sponsoring NCT03688802?

NCT03688802 is sponsored by Oyster Point Pharma, Inc..

What drugs are being tested in NCT03688802?

Interventions in NCT03688802: OC-01 (varenicline) nasal spray, Placebo (vehicle control) nasal spray.

What condition does NCT03688802 study?

NCT03688802 studies Dry Eye Disease.

Is NCT03688802 still recruiting?

NCT03688802 is currently completed. Last updated 29 December 2021.

Are results published for NCT03688802?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-12-29 · How we verify

NCT03688802

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation

Completed Phase 2 Results posted Last updated 29 December 2021

What this trial tests

Phase 2 trial testing OC-01 (varenicline) nasal spray in Dry Eye Disease in 18 participants. Completed in 30 September 2019.

Timeline

25 September 2018

Primary endpoint
30 September 2019

30 September 2019

Quick facts

Lead sponsor	Oyster Point Pharma, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	18
Start date	25 September 2018
Primary completion	30 September 2019
Estimated completion	30 September 2019
Sites	1 location across United States

Drugs / interventions tested

OC-01 (varenicline) nasal spray — full drug profile →
Placebo (vehicle control) nasal spray — full drug profile →

Conditions studied

Dry Eye Disease — all drugs for Dry Eye Disease →

Sponsor

Oyster Point Pharma, Inc. — full company profile →

Who can join

18 and older, any sex, with Dry Eye Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change in Goblet Cell Area Primary · Baseline (pre-treatment), 1 day (post treatment)

Mean change in Goblet Cell Area with a larger decrease is indicative of a better outcome.

Group	Value	95% CI
OC-01, 1.2 mg/mL	-38.8	± 30.20
Placebo	-6.7	± 1.94

Mean Change in Goblet Cell Perimeter Primary · Baseline (pre-treatment), 1 day (post treatment)

Mean change in Goblet Cell Perimeter. A larger decrease is indicative of a better outcome.

Group	Value	95% CI
OC-01, 1.2 mg/mL	-7.7	± 5.79
Placebo	-1.8	± 0.76

Change in Meibomian Gland Area, Upper Lid Primary · Baseline (pre-treatment), 1 day (post treatment)

Change in Meibomian gland area, upper lid. A larger decrease is indicative of a better outcome

Group	Value	95% CI
OC-01, 1.2 mg/mL	11.2	± 118.6
Placebo	-143.2	± 154.8

Mean Change in Meibomian Gland Area, Lower Lid. Primary · Baseline (pre-treatment), 1 day (post treatment)

Mean change in Meibomian Gland Area, lower Lid. A larger decrease is indicative of a better outcome.

Group	Value	95% CI
OC-01, 1.2 mg/mL	-29.9	± 88.1
Placebo	-12.4	± 95.8

Mean Change in Meibomian Gland Perimeter, Upper Lid. Primary · Baseline (pre-treatment), 1 day (post treatment)

Chane in Meibomian Gland Perimeter, upper lid. A larger decrease is indicative of a better outcome.

Group	Value	95% CI
OC-01, 1.2 mg/mL	6.15	± 16.6
Placebo	-19.2	± 22.8

Mean Change in Meibomian Gland Perimeter, Lower Lid Primary · Baseline (pre-treatment), 1 day (post treatment)

Mean change in Meibomian Gland Perimeter, lower lid. A larger decrease is indicative of a better outcome.

Group	Value	95% CI
OC-01, 1.2 mg/mL	-4	± 10.9
Placebo	4.2	± 19.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from the time of study drug administration to the last study visit (pre to post treatment 1 day).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

OC-01, 1.2 mg/mL

Serious: 0/12 (0%)

Deaths: 0/12

Placebo

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (3 terms — click to expand)

Reaction	System	OC-01, 1.2 mg/mL	Placebo
Sneezing	Respiratory, thoracic and mediastinal disorders	—	—
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	—	—
TEAE	Eye disorders	—	—

Data from ClinicalTrials.gov NCT03688802 adverse events section.

Sponsor's own description

The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo in simulating Goblet Cell and Meibomian Gland function in adult subjects with DED.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A Single Administration of OC-01 (Varenicline Solution) Nasal Spray Induces Short-Term Alterations in Conjunctival Goblet Cells in Patients with Dry Eye Disease.
Dieckmann GM, Cox SM, Lopez MJ, Ozmen MC, et al · · 2022 · cited 10× · PMID 35653029 · DOI 10.1007/s40123-022-00530-x

Verify or expand the search:

Other trials of OC-01 (varenicline) nasal spray

Trials testing the same drug.

NCT04036292 — Evaluation of the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease · Phase 3 · completed
NCT03636061 — Evaluation of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease · Phase 2 · completed

Other recruiting trials for Dry Eye Disease

Currently open trials in the same condition.

NCT06596733 — Vit-A-Vision® Clinical Investigation · NA · recruiting
NCT07264517 — Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED). · Phase 2 · recruiting
NCT07025811 — A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment · Phase 4 · recruiting
NCT04946721 — 2177GCCC:ID'Ing tx Targets and Biomarkers for Ocular Surface Disease in Pt w/ oGVHD · recruiting
NCT06696625 — Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye · NA · recruiting

Other Oyster Point Pharma, Inc. trials

Trials by the same sponsor.

NCT06329687 — A Study Evaluating the Safety of the Nasal Pump · Phase 4 · terminated
NCT05918406 — Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya · Phase 4 · completed
NCT04957758 — Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in Subjects With Neurotrophic Keratopathy · Phase 2 · completed
NCT04072146 — Evaluating Relative Bioavailability of OC-01 (Varenicline) Nasal Spray as Compared to Orally Administered Varenicline · Phase 1 · completed
NCT04036292 — Evaluation of the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03688802 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oyster Point Pharma, Inc.
Last refreshed: 29 December 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03688802.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing