A Phase 3 interventional study of Vehicle of Loteprednol Etabonate and Loteprednol Etabonate in Inflammation and Pain, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-09.
Sponsored by Bausch & Lomb Incorporated (part of Bausch Health Companies Inc.) · Phase 3, Interventional, and Treatment
This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
3,512 studies on the registry are indexed under Inflammation; 640 are open to participants now.
This study's enrollment of 406 is above the median of 50 across 2,491 interventional studies indexed under Inflammation.
Browse Inflammation studies →Bausch & Lomb Incorporated is the lead sponsor of 223 studies on the registry; 5 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 41 (80%) have results posted.
First submitted before Bausch & Lomb Incorporated became part of Bausch Health Companies Inc..
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Exclusion Criteria:
Loteprednol etabonate
Drug: Loteprednol Etabonate
Vehicle of loteprednol etabonate
Drug: Vehicle of Loteprednol Etabonate
1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.
1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.
Resolution of Anterior Chamber Cells (ACC).
Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.
Time frame: Visit 5 (Postoperative day 8)
Grade 0 Pain
Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.
Time frame: Visit 5 (Postoperative Day 8)
Resolution of Anterior Chamber Cells.
Study eyes with complete resolution of anterior chamber cells (ACC)
Time frame: At visits 4-7- postoperative day 3, 8,15 & 18
This study was initiated at 20 clinics in the United States (US). Three sites did not enroll any participants. The study was conducted at the remaining 17 sites. First participant was enrolled 11/23/2009 and last participant completed 6/25/2010.
| Milestone | Loteprednol | Vehicle |
|---|---|---|
| Started | 203 | 203 |
| Completed | 199 | 198 |
| Not completed | 4 | 5 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Protocol violation | 1 | 2 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Investigator decision | 0 | 1 |
Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.
| Eyes | Loteprednol | Vehicle |
|---|---|---|
| Resolution of Anterior Chamber Cells (ACC). | 62 | 33 |
Study eyes with complete resolution of anterior chamber cells (ACC)
| Eyes | Loteprednol | Vehicle |
|---|---|---|
| Visit 4 | 17 | 11 |
| Visit 5 | 62 | 33 |
| Visit 6 | 102 | 44 |
| Visit 7 | 96 | 45 |
Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.
| Eyes | Loteprednol | Vehicle |
|---|---|---|
| Grade 0 Pain | 148 | 85 |
Collected over Visit 3 post-operative day 1 thru visit 7 postoperative day 18. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Loteprednol | — | 1/203 (0.5%) | 0/203 (0%) |
| Vehicle | — | 2/203 (1%) | 0/203 (0%) |
| Event | Loteprednol | Vehicle |
|---|---|---|
| Cystoid Macular EdemaEye disorders | 1/203 | 1/203 |
| BronchitisRespiratory, thoracic and mediastinal disorders | 0/203 | 1/203 |
| Heart FailureCardiac disorders | 0/203 | 1/203 |
| Age Continuous(years) | Loteprednol | Vehicle | Total |
|---|---|---|---|
| Mean | 69.3 ± 8.73 | 69.0 ± 9.80 | 69.1 ± 9.27 |
| Sex: Female, Male(Participants) | Loteprednol | Vehicle | Total |
|---|---|---|---|
| Female | 109 | 122 | 231 |
| Male | 94 | 81 | 175 |
| Race/Ethnicity, Customized(participants) | Loteprednol | Vehicle | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 2 | 3 | 5 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 20 | 16 | 36 |
| White | 176 | 182 | 358 |
| Other | 4 | 1 | 5 |
The record gives a start of Nov 2009, a primary completion of Jun 2010 and a completion of Aug 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2012, 1 year 7 months after primary completion.
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This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Loteprednol Etabonate