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Comparison · NCT01602068-977bb53d

Dexamethasone Phosphate Ophthalmic vs 100 mM Sodium Citrate Buffer: Percentage of Subjects With AC Cell Count of Zero on Day 7

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Dexamethasone Phosphate Ophthalmic vs 100 mM Sodium Citrate Buffer: Percentage of Subjects With AC Cell Count of Zero on Day 7. Trial comparisons, record NCT01602068-977bb53d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01602068-977bb53d

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.130.04540.321wilson
Risk in group 20.09090.02530.278wilson
Risk difference, group 1 minus group 20.0395-0.1660.241newcombe hybrid score
Risk ratio, group 1 over group 21.430.2647.78log
Odds ratio, group 1 over group 21.50.2269.96log
Number needed to treat, for one more participant with the outcome on Dexamethasone Phosphate Ophthalmic than on 100 mM Sodium Citrate Buffer25.3from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Dexamethasone Phosphate OphthalmicDexamethasone Phosphate Ophthalmic: (40 mg/mL) solution delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)323OG000
Group 2100 mM Sodium Citrate BufferPlacebo (100 mM sodium citrate buffer solution) delivered by transcleral iontophoresis consisting of 4.0 mA-min at 1.5 mA on Day -1 (the day before cataract surgery)222OG001

Outcome

Type
PRIMARY
Title
Percentage of Subjects With AC Cell Count of Zero on Day 7
Description
Percentage of patients with anterior chamber (AC) cell count of zero on Day 7 as compared between the active and placebo groups
Time frame
At Day 7 (plus or minus two days) following the study treatment
Population
This was an exploratory study and therefore a number of efficacy and safety parameters were evaluated. In all measures there was no significant difference between the active and non-active arms.

Source ClinicalTrials.gov

Trial

Title
Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOL
NCT number
NCT01602068
Phases
PHASE2
Conditions
Cataract
Interventions
Dexamethasone Phosphate Ophthalmic, 100 mM Sodium Citrate Buffer
Lead sponsor
Eyegate Pharmaceuticals, Inc.
Results first posted
2018-05-21

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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