NCT01276223.

Study characteristics
Methods	00. Study design: randomized controlled trial, parallel group 01. Calendar time when the study enrolled the first participant (YYYY/MM): 2011/02 (ClinicalTrials.gov) 02. Calendar time when the study completed follow‐up (YYYY/MM): 2012/01 (ClinicalTrials.gov) 03. Unit of randomization (participant or eye): participant 04. Masking of participants, treatment allocator, outcome assessor, or data analyzer: double (participant, investigator) 05. Study visits and the corresponding time points: baseline, week 1, 2, 3, 4 06. Instruments and the scales used for documenting patient‐reported symptoms or quality of life: VAS was used by the participant to assess ocular discomfort, both frequency and severity, at baseline (pre‐treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 mm in length. The VAS score was calculated by measuring the length in millimeters from the start of the line to the intersection point of the vertical mark made by the participant. The Global Ocular Discomfort Score is a composite of the 2 VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable). 07. Assessment for safety outcomes: NR 08. Planned follow‐up duration: 4 weeks 09. Actual follow‐up duration: 4 weeks 10. Planned treatment duration (of the intervention steroid): 4 weeks 11. How missing data were handled: of the 722 participants enrolled, 433 did not qualify for run‐in and were exited without exposure to product. Of the 289 participants entering run‐in, 78 did not qualify for treatment. The 211 participants qualifying for treatment were randomized 1:1 to receive either difluprednate (Durezol) or vehicle. Mixed model repeated measure (MMRM) approach was used to handle missing data during the randomized treatment period; 4 and 3 participants in the difluprednate and vehicle groups did not complete the study. 12. Description on power and sample size calculation: NR
Participants	Country: USA Setting: participants were recruited from 25 investigative sites Interventions: Difluprednate 0.05% ophthalmic emulsion (Durezol) Age, mean/SD (range): 54.4/14.8 Female, n (%): 90 (84.1%) Etiology, n (%): NR Participants (eyes) randomized: 107 Participants (eyes) analyzed for primary study outcomes: 107 Participants (eyes) analyzed for safety outcomes: 107 Difluprednate vehicle Age, mean/SD (range): 60.1/13.8 Female, n (%): 85 (81.7%) Etiology, n (%): NR Participants (eyes) randomized: 104 Participants (eyes) analyzed for primary study outcomes: 104 Participants (eyes) analyzed for safety outcomes: 104 Overall Age, mean/SD (range): 57.2/14.6 Female, n (%): 175 (82.9%) Etiology, n (%): NR Participants (eyes) randomized: 211 Participants (eyes) analyzed for primary study outcomes: 211 Participants (eyes) analyzed for safety outcomes: 211 Inclusion criteria: Normal subjects: no known history of dry eye disease; non‐contact lens wearer; no current use of artificial tears or any other dry eye treatment Dry eye patients: at least a 6‐month history of dry eye; non‐contact lens wearer; uses artificial tears; experiences persistent ocular discomfort; other protocol‐defined inclusion criteria may apply Exclusion criteria:  The presence of any acute infectious or non‐infectious ocular conditions in either eye within 1 month of visit 1 Severe Sjögren's syndrome Lid function abnormalities Use of steroids, tetracycline, doxycycline, etc., within 30 days of visit 1 History of corneal surgery including refractive surgeries History of glaucoma or ocular hypertension  Other protocol‐defined exclusion criteria may apply Baseline comparison: participants in the difluprednate group were 5.7 years younger than those in the vehicle group (post hoc P = 0.004)
Interventions	Difluprednate 0.05% ophthalmic emulsion (Durezol), 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week to allow for tapering Difluprednate vehicle, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week
Outcomes	Time points of primary outcome data collected: at week 4 Primary outcomes of the study: mean change from baseline (Week 0) in VAS Global Ocular Discomfort Score over 4 weeks Other outcomes of the study: NR
Study Identification	Sponsorship source: Alcon Research Ethics approval: NR Correspondence author's name: NR Additional information: Trial registration no.: NCT01276223 Trial registration website: ClinicalTrials.gov Financial disclosure or conflicts of interest statement from authors: NR
Notes