Trial · NCT00854061
Study of T-PRED(TM) Compared to Pred Forte(R) II
NCT00854061, Phase 3, Completed, Bausch & Lomb Incorporated; results first posted 2020-10-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of T-PRED(TM) Compared to Pred Forte(R) II. Trials, record NCT00854061. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00854061
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of T-PRED(TM) Compared to Pred Forte(R) II
- NCT number
- NCT00854061
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 172 participants, actual
- Lead sponsor
- Bausch & Lomb Incorporated
- Conditions
- Cataract
- Interventions
- T-Pred, Pred Forte
- First posted
- 2009-03-02
- Last updated
- 2020-10-20
- Results first posted
- 2020-10-20
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Means Aqueous Humor Prednisolone Acetate Concentration | 35 days |
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 | Means Aqueous Humor Prednisolone Acetate Concentration | 35 days | Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned. | ng/mL | MEAN |
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 |
|---|---|---|---|---|---|
| Means Aqueous Humor Prednisolone Acetate Concentration | T-Pred | 100.02 | Standard Deviation 9.61 | ng/mL | |
| Means Aqueous Humor Prednisolone Acetate Concentration | Pred Forte | 131.65 | Standard Deviation 9.61 | ng/mL |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Study Participants | 172 | |
| Overall Study | Completed 1st Surgery (T-PRED in One Eye and Pred Forte in the Other Eye) | All Study Participants | 162 | |
| Overall Study | Completed 2nd Surgery (T-PRED and Pred Forte in Opposite Eyes Compared to 1st Surgery) | All Study Participants | 149 | |
| Overall Study | COMPLETED | All Study Participants | 149 | |
| Overall Study | NOT COMPLETED | All Study Participants | 23 |
Source ClinicalTrials.gov
Adverse events4
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 |
|---|---|---|---|---|---|---|
| serious | IOL dislocation | Eye disorders | T-Pred | 1 | 162 | |
| serious | IOL dislocation | Eye disorders | Pred-Forte | 0 | 162 | |
| serious | Vitritis | Eye disorders | T-Pred | 0 | 162 | |
| serious | Vitritis | Eye disorders | Pred-Forte | 1 | 162 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | T-Pred | ||
| Total, all-cause mortality | Pred-Forte | ||
| Total, other adverse events | T-Pred | 0 | 162 |
| Total, other adverse events | Pred-Forte | 0 | 162 |
| Total, serious adverse events | T-Pred | 1 | 162 |
| Total, serious adverse events | Pred-Forte | 1 | 162 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| T-Pred vs Pred-Forte: serious adverse events |
Source 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/NCT00854061
GET https://conductscience.org/api/trials/v1/NCT00854061/registered