Who is sponsoring NCT01212471?

NCT01212471 is sponsored by Bausch & Lomb Incorporated.

What drugs are being tested in NCT01212471?

Interventions in NCT01212471: Bromfenac Ophthalmic Solution A, Bromfenac Ophthalmic Solution B, Placebo Comparator.

What condition does NCT01212471 study?

NCT01212471 studies Dry Eye Syndrome.

Is NCT01212471 still recruiting?

NCT01212471 is currently completed. Last updated 2 September 2020.

Are results published for NCT01212471?

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

NCT01212471

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

A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease

Completed Phase 3 Results posted Last updated 2 September 2020

What this trial tests

Phase 3 trial testing Bromfenac Ophthalmic Solution A in Dry Eye Syndrome in 840 participants. Completed in 1 December 2011.

Timeline

1 September 2010

Primary endpoint
1 August 2011

1 December 2011

Quick facts

Lead sponsor	Bausch & Lomb Incorporated
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	840
Start date	1 September 2010
Primary completion	1 August 2011
Estimated completion	1 December 2011
Sites	1 location across United States

Drugs / interventions tested

Bromfenac Ophthalmic Solution A — full drug profile →
Bromfenac Ophthalmic Solution B — full drug profile →
Placebo Comparator

Conditions studied

Dry Eye Syndrome — all drugs for Dry Eye Syndrome →

Sponsor

Bausch & Lomb Incorporated — full company profile →

Who can join

18 and older, any sex, with Dry Eye Syndrome. 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.

Mean Ocular Surface Disease Index (OSDI) Total Score
Time frame: 42 days
The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes.

Sponsor's own description

A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.

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 recruiting trials for Dry Eye Syndrome

Currently open trials in the same condition.

NCT07295691 — Autologous Serum Eye Drops in Dry Eye Syndrome · NA · recruiting
NCT06914232 — Efficacy of Warm Compress Therapy in Enhancing Tear Film Quality and Reducing Postoperative DES · NA · active not recruiting
NCT06913556 — Comparing Effect of Hylorunic Acid and Lipid-coated Carbomer Gel on Dry Eyes After Phacoemulsification in DP · NA · 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 NCT01212471 (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/NCT01212471.

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