Trial · NCT01602068
Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOL
NCT01602068, Phase 2, Completed, Eyegate Pharmaceuticals, Inc.; results first posted 2018-05-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOL. Trials, record NCT01602068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01602068
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOL
- NCT number
- NCT01602068
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- Eyegate Pharmaceuticals, Inc.
- Conditions
- Cataract
- Interventions
- Dexamethasone Phosphate Ophthalmic, 100 mM Sodium Citrate Buffer
- First posted
- 2012-05-18
- Last updated
- 2019-01-29
- Results first posted
- 2018-05-21
- Limitations and caveats
The surgical procedure eliminates or washes out any remaining study drug product from the ocular tissue which becomes inflamed post-surgery. Exploratory study with multiple efficacy \& safety parameters were evaluated.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With AC Cell Count of Zero on Day 7 | At Day 7 (plus or minus two days) following the study treatment | Percentage of patients with anterior chamber (AC) cell count of zero on Day 7 as compared between the active and placebo groups |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With AC Cell Count of Zero on Day 7 | At Day 7 (plus or minus two days) following the study treatment | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With AC Cell Count of Zero on Day 7 | Dexamethasone Phosphate Ophthalmic | 3 | Participants | ||
| Percentage of Subjects With AC Cell Count of Zero on Day 7 | 100 mM Sodium Citrate Buffer | 2 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dexamethasone Phosphate Ophthalmic | 23 | |
| Overall Study | STARTED | 100 mM Sodium Citrate Buffer | 22 | |
| Overall Study | COMPLETED | Dexamethasone Phosphate Ophthalmic | 23 | |
| Overall Study | COMPLETED | 100 mM Sodium Citrate Buffer | 22 | |
| Overall Study | NOT COMPLETED | Dexamethasone Phosphate Ophthalmic | 0 | |
| Overall Study | NOT COMPLETED | 100 mM Sodium Citrate Buffer | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ocular AE | Eye disorders | Dexamethasone Phosphate Ophthalmic | 21 | 23 | 84 |
| other | Ocular AE | Eye disorders | 100 mM Sodium Citrate Buffer | 20 | 22 | 70 |
| serious | Cholelithiasis | Hepatobiliary disorders | Dexamethasone Phosphate Ophthalmic | 0 | 23 | 0 |
| serious | Cholelithiasis | Hepatobiliary disorders | 100 mM Sodium Citrate Buffer | 1 | 22 | 1 |
| serious | Abdominal pain | Gastrointestinal disorders | Dexamethasone Phosphate Ophthalmic | 0 | 23 | 0 |
| serious | Abdominal pain | Gastrointestinal disorders | 100 mM Sodium Citrate Buffer | 1 | 22 | 1 |
| serious | Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Dexamethasone Phosphate Ophthalmic | 0 | 23 | 0 |
| serious | Respiratory Distress | Respiratory, thoracic and mediastinal disorders | 100 mM Sodium Citrate Buffer | 1 | 22 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dexamethasone Phosphate Ophthalmic | ||
| Total, all-cause mortality | 100 mM Sodium Citrate Buffer | ||
| Total, other adverse events | Dexamethasone Phosphate Ophthalmic | 21 | 23 |
| Total, other adverse events | 100 mM Sodium Citrate Buffer | 20 | 22 |
| Total, serious adverse events | Dexamethasone Phosphate Ophthalmic | 0 | 23 |
| Total, serious adverse events | 100 mM Sodium Citrate Buffer | 3 | 22 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dexamethasone Phosphate Ophthalmic vs 100 mM Sodium Citrate Buffer: Percentage of Subjects With AC Cell Count of Zero on Day 7 | Trial comparisons |
| Dexamethasone Phosphate Ophthalmic vs 100 mM Sodium Citrate Buffer: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01602068
GET https://conductscience.org/api/trials/v1/NCT01602068/registered