NCT02965846 is a Phase 3 clinical trial of AGN-195263 in Dry Eye Syndromes, sponsored by Allergan.

Who is sponsoring NCT02965846?

NCT02965846 is sponsored by Allergan.

What drugs are being tested in NCT02965846?

Interventions in NCT02965846: AGN-195263, Vehicle.

What condition does NCT02965846 study?

NCT02965846 studies Dry Eye Syndromes.

Is NCT02965846 still recruiting?

NCT02965846 is currently terminated. Last updated 30 November 2018.

Are results published for NCT02965846?

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

Last reviewed 2018-11-30 · How we verify

NCT02965846

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

Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye

Terminated Phase 3 Results posted Last updated 30 November 2018

What this trial tests

Phase 3 trial testing AGN-195263 in Dry Eye Syndromes in 43 participants. Terminated before completion.

Timeline

13 December 2016

Primary endpoint
13 June 2017

13 June 2017

Quick facts

Lead sponsor	Allergan
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	43
Start date	13 December 2016
Primary completion	13 June 2017
Estimated completion	13 June 2017
Sites	49 locations across France, Italy, Taiwan, United Kingdom, Germany, Hungary, Poland, Philippines

Drugs / interventions tested

AGN-195263 — full drug profile →
Vehicle

Conditions studied

Dry Eye Syndromes — all drugs for Dry Eye Syndromes →

Sponsor

Allergan — full company profile →

Who can join

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

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 157 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AGN-195263

Serious: 0/5 (0%)

Deaths: 0/5

Vehicle

Serious: 0/5 (0%)

Deaths: 0/5

Other adverse events (1 terms — click to expand)

Reaction	System	AGN-195263	Vehicle
Vision Blurred	Eye disorders	—	—

Data from ClinicalTrials.gov NCT02965846 adverse events section.

Sponsor's own description

The objectives of this study are twofold •To evaluate the safety and efficacy of 0.1% AGN-195263 administered twice daily compared to its vehicle in patients with evaporative dry eye (EDE) •To evaluate the systemic pharmacokinetics of 0.1% AGN-195263 administered twice daily in patients with EDE

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of AGN-195263

Trials testing the same drug.

NCT02815293 — Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye · Phase 3 · terminated

Other recruiting trials for Dry Eye Syndromes

Currently open trials in the same condition.

NCT07412860 — Clinical Investigation Between the Topical Administration of a Tear Substitute With Ancillary Medicinal Substance and Hy · NA · recruiting
NCT06913504 — Comparison Of Blue Light Filter Feature and Blue Blocking Lenses in Digital Device Users With Dry Eye Patients · NA · active not recruiting
NCT06913465 — The Impact of Hypothyroidism on Tear Production and Dry Eye Symptoms: Implications for Optometric Care · active not recruiting
NCT06831253 — Efficacy of Platelet-Rich Plasma Injection in Dry Eye Syndrome · NA · recruiting
NCT06220474 — Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD · NA · recruiting

Other Allergan trials

Trials by the same sponsor.

NCT04609020 — Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treatment · Phase 4 · completed
NCT05452070 — A Study to Assess Adverse Events and Change in Disease Activity of HArmonyCa Lidocaine Injectable Gel for Mid Face Soft · Phase 3 · completed
NCT05393089 — Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopi · Phase 2 · withdrawn
NCT05152576 — A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants Wi · Phase 2 · completed
NCT05088980 — Study to Assess Effectiveness and Adverse Events of JUVEDERM VOLBELLA With Lidocaine Injection in Correcting Infraorbita · 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 NCT02965846 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allergan
Last refreshed: 30 November 2018

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/NCT02965846.

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