Trial Outcomes & Findings for A Retrospective Evaluation of the Intraocular Pressure Spikes With Loteprednol and Loteprednol/Tobramycin (NCT NCT00834171)

Results Overview

Mean elevated IOP during treatment. IOP is a measurement of the fluid pressure inside the eye. IOP was recorded any time an elevation of IOP (increase of 5 mmHg or more) occurred while using study treatment. The median duration of treatment at the time of observed IOP elevation was 55 days.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

55 days

Results posted on

2011-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	Loteprednol Etabonate Ophthalmic Suspension 0.5% Loteprednol etabonate ophthalmic suspension 0.5%	Loteprednol Etabonate (0.5%) and Tobramycin (0.3%) Loteprednol etabonate (0.5%) and tobramycin (0.3%)
Overall Study STARTED	43	7
Overall Study COMPLETED	43	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Retrospective Evaluation of the Intraocular Pressure Spikes With Loteprednol and Loteprednol/Tobramycin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Loteprednol Etabonate Ophthalmic Suspension 0.5% n=43 Participants Loteprednol etabonate ophthalmic suspension 0.5%	Loteprednol Etabonate (0.5%) and Tobramycin (0.3%) n=7 Participants Loteprednol etabonate (0.5%) and tobramycin (0.3%)	Total n=50 Participants Total of all reporting groups
Age Continuous	NA years n=5 Participants	NA years n=7 Participants	58.8 years n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants	NA Participants n=7 Participants	—
Sex: Female, Male Male	NA Participants n=5 Participants	NA Participants n=7 Participants	—

PRIMARY outcome

Timeframe: 55 days

Population: Intent to treat, which included all patients in the study.

Mean elevated IOP during treatment. IOP is a measurement of the fluid pressure inside the eye. IOP was recorded any time an elevation of IOP (increase of 5 mmHg or more) occurred while using study treatment. The median duration of treatment at the time of observed IOP elevation was 55 days.

Outcome measures

Outcome measures
Measure	Loteprednol Etabonate Ophthalmic Suspension 0.5% n=43 Participants Loteprednol etabonate ophthalmic suspension 0.5%	Loteprednol Etabonate (0.5%) and Tobramycin (0.3%) n=7 Participants Loteprednol etabonate (0.5%) and tobramycin (0.3%)
Mean Elevated Intraocular Pressure (IOP) During Treatment	24.8 Millimeters of mercury (mmHg) Standard Deviation 6.9	23.9 Millimeters of mercury (mmHg) Standard Deviation 3.5

Adverse Events

Loteprednol Etabonate Ophthalmic Suspension 0.5%

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Loteprednol Etabonate Ophthalmic Suspension 0.5% n=43 participants at risk Loteprednol etabonate ophthalmic suspension 0.5%	Loteprednol Etabonate (0.5%) and Tobramycin (0.3%) n=7 participants at risk Loteprednol etabonate (0.5%) and tobramycin (0.3%)
Surgical and medical procedures Glaucoma surgery	9.3% 4/43	0.00% 0/7

Additional Information

Vice President Medical Affairs

Allergan, Inc.

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Publication restrictions are in place

Restriction type: OTHER