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Record W2935464438 · doi:10.1016/j.ogla.2019.03.007

Once-Daily Netarsudil/Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure in the Randomized Phase 3 MERCURY-2 Study

2019· article· en· W2935464438 on OpenAlexaff
Thomas R. Walters, Iqbal Ike K. Ahmed, Richard A. Lewis, Dale W. Usner, Jae Lopez, Casey Kopczynski, Theresa Heah

Bibliographic record

VenueOphthalmology Glaucoma · 2019
Typearticle
Languageen
FieldMedicine
TopicGlaucoma and retinal disorders
Canadian institutionsUniversity of Toronto
FundersAerie Pharmaceuticals
KeywordsLatanoprostMedicineOcular hypertensionProstaglandin analogueIntraocular pressureAnesthesiaGlaucomaOphthalmology

Abstract

fetched live from OpenAlex

PURPOSE: To compare the ocular hypotensive efficacy and safety of a once-daily (pm) fixed-dose combination (FDC) product containing netarsudil 0.02% and latanoprost 0.005% with monotherapy with netarsudil or latanoprost. Netarsudil is a Rho kinase inhibitor that lowers intraocular pressure (IOP) primarily by increasing trabecular (conventional) outflow. Latanoprost is the most frequently prescribed of the prostaglandin analogs, which lower IOP primarily by increasing uveoscleral outflow. DESIGN: Three-month, double-masked, randomized (1:1:1), phase 3, superiority study. PARTICIPANTS: Patients had unmedicated IOP > 20 to <36 mmHg at 8:00 am and met other standard criteria for open-angle glaucoma and ocular hypertension. METHODS: Randomization to once-daily (pm) netarsudil/latanoprost FDC, netarsudil, or latanoprost for 3 months. MAIN OUTCOME MEASURES: Mean IOP at 8:00 am, 10:00 am, and 4:00 pm at week 2, week 6, and month 3 (intent-to-treat). Statistical superiority was concluded if the P value for the comparison of netarsudil/latanoprost FDC with each component was <0.05 and the difference in mean IOP (netarsudil/latanoprost FDC minus comparator) was <0 for all time points at all visits. Safety was recorded throughout the treatment period. RESULTS: A total of 750 patients were enrolled, with 90.2%, 89.4%, and 94.4% completing 3 months of treatment with netarsudil/latanoprost FDC, netarsudil, and latanoprost, respectively. Least-squares mean treated IOP ranged from 15.3 to 16.5 mmHg for netarsudil/latanoprost FDC, 17.4 to 19.8 mmHg for netarsudil, and 17.1 to 18.1 mmHg for latanoprost. Netarsudil/latanoprost FDC met the criteria for superiority to each active component at all 9 time points (all P < 0.0001), lowering IOP by an additional 2.2 to 3.3 mmHg versus netarsudil and an additional 1.5 to 2.4 mmHg versus latanoprost. At month 3, the proportion of patients achieving mean diurnal IOP ≤ 15 mmHg was 42.1% for netarsudil/latanoprost FDC, 15.8% for netarsudil, and 18.3% for latanoprost. No treatment-related serious adverse event (AE) was observed. Treatment-related systemic AEs were minimal. The most frequent ocular AE was conjunctival hyperemia (netarsudil/latanoprost FDC, 54.5%; netarsudil, 42.7%; latanoprost, 22.3%), which was generally mild. CONCLUSIONS: Once-daily netarsudil/latanoprost FDC demonstrated IOP reductions that were statistically and clinically superior to its individual components at all 9 time points over 3 months, with tolerable ocular safety. This FDC offers a reduced treatment burden that may improve adherence and clinical outcomes.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.391
Threshold uncertainty score0.991

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0020.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.014
GPT teacher head0.308
Teacher spread0.294 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations60
Published2019
Admission routes1
Has abstractyes

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