NCT01289431 is a Phase 2 clinical trial of Mapracorat in Conjunctivitis, Allergic, sponsored by Bausch & Lomb Incorporated.

Who is sponsoring NCT01289431?

NCT01289431 is sponsored by Bausch & Lomb Incorporated.

What drugs are being tested in NCT01289431?

Interventions in NCT01289431: Mapracorat, Vehicle.

What condition does NCT01289431 study?

NCT01289431 studies Conjunctivitis, Allergic.

Is NCT01289431 still recruiting?

NCT01289431 is currently completed. Last updated 2 September 2020.

Are results published for NCT01289431?

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

Last reviewed 2020-09-02 · How we verify

NCT01289431

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

Dose Ranging Study to Evaluate the Safety and Efficacy of Mapracorat Ophthalmic Formulation, in Subjects With Allergic Conjunctivitis Compared to Vehicle in a Conjunctival Allergen Challenge (CAC).

Completed Phase 2 Results posted Last updated 2 September 2020

What this trial tests

Phase 2 trial testing Mapracorat in Conjunctivitis, Allergic in 236 participants. Completed in 1 April 2011.

Timeline

1 February 2011

Primary endpoint
1 April 2011

1 April 2011

Quick facts

Lead sponsor	Bausch & Lomb Incorporated
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	236
Start date	1 February 2011
Primary completion	1 April 2011
Estimated completion	1 April 2011
Sites	1 location across United States

Drugs / interventions tested

Mapracorat — full drug profile →
Vehicle

Conditions studied

Conjunctivitis, Allergic — all drugs for Conjunctivitis, Allergic →

Sponsor

Bausch & Lomb Incorporated — full company profile →

Who can join

12 and older, any sex, with Conjunctivitis, Allergic. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Ocular Itching
Time frame: 8 hours
Ocular itching was assessed by the participant on a 0-4 scale with half unit increments allowed. Lower scores indicate less ocular itching.
Conjunctival Redness
Time frame: 8 hours
Conjunctival redness was assessed by the Investigator on a 0-4 scale with half unit increments allowed. Lower scores indicate less conjunctival redness.

Sponsor's own description

The objective of this study is to evaluate the dose response, and efficacy of Mapracorat ophthalmic formulation compared to its vehicle for the prevention of symptoms and signs associated with allergic conjunctivitis using a conjunctival allergen challenge (CAC) model.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Mapracorat

Trials testing the same drug.

NCT01408511 — HPA Axis Study in Adults · Phase 2 · completed
NCT01407510 — HPA Axis Study in Japanese Adults · Phase 2 · completed

Other recruiting trials for Conjunctivitis, Allergic

Currently open trials in the same condition.

NCT07385495 — OJO-miR: microRNA Expression in Allergic Conjunctivitis. · active not recruiting

Other Bausch & Lomb Incorporated trials

Trials by the same sponsor.

NCT07054606 — A Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear · Phase 4 · completed
NCT06803654 — A Study Comparing the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% With Sodium Hyaluronate Rel · Phase 3 · completed
NCT06594185 — A Study to Evaluate Real World Outcomes of the enVista® Aspire (EA) and Aspire Toric (ETA) Intraocular Lens in Subjects · NA · completed
NCT06479148 — Clinical Evaluation of the Performance of the enVista® Aspire™ (EA) Lens · NA · terminated
NCT06333028 — A Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction · 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 NCT01289431 (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 Bausch & Lomb Incorporated
Last refreshed: 2 September 2020

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/NCT01289431.

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