Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty

• Sponsor: Cornea Research Foundation of America (Other)
• Overall Status: Completed
• CT.gov ID: NCT01853696
• Collaborator: (none)
• Enrollment: 167
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 7.6

Study Details

Study Description

Brief Summary

Graft rejection has traditionally been one of the leading causes of cornea transplant failure. To help prevent rejection, corticosteroid eye drops are used for an extended period after transplant surgery. The purpose of this study is to compare the efficacy and side effects of different corticosteroid dosing regimens after endothelial keratoplasty (cornea transplant) surgery.

Condition or Disease	Intervention/Treatment	Phase
Fuchs' Dystrophy; Corneal Edema	Drug: loteprednol etabonate; Drug: prednisolone acetate 1%	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 167 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Prospective, Randomized Comparison of Corticosteroid Dosing Regimens Following Endothelial Keratoplasty
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Loteprednol Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months	Drug: loteprednol etabonate; Other Names: Lotemax gel
Active Comparator: Prednisolone acetate Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months	Drug: prednisolone acetate 1%

Outcome Measures

Primary Outcome Measures

1. Intraocular Pressure [from 1 to 12 months after transplant]

   Number of eyes in which the absolute intraocular pressure equaled or exceeded 24 mm Hg OR in which there was a relative increase of at least 10 mm Hg over the baseline preoperative reading.

Secondary Outcome Measures

1. Immunologic Graft Rejection Episode [within first year after cornea transplantation]

   Rejection episodes were assessed by slit lamp examination and categorized as definite when an endothelial rejection line was detected in a previously clear graft, probable when inflammation (stromal infiltrate, keratic precipitates, cells in the anterior chamber, or ciliary injection) was detected in a previously clear graft without an endothelial rejection line, and possible if central corneal pachymetry increased by 30 microns or more, even if the cornea was clear and no inflammation was detected by slit lamp examination.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• At least 18 years of age

• Male or female patient who had endothelial keratoplasty procedure within the past 1 to 7 weeks

• Patient is able and willing to administer eye drops

• Patient is able to comprehend and has signed the Informed Consent form.

• Patient is likely to complete the one-year course of the study

Exclusion Criteria:

• A history of a previous rejection episode in the study eye

• A patient exhibiting intraocular inflammation

• A patient with a known sensitivity to any of the ingredients in the study medications

• A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study

• A patient with abnormal eyelid function.

• A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis.

• Presence of any ocular disease that would interfere with the evaluation of the study treatment. However, patients with a history of cystoid macular edema, age-related macular degeneration, controlled glaucoma, corneal neovascularization, and other non-interfering comorbidities may be enrolled.

• A patient with a history of non-compliance with using prescribed medication.

• A patient who is concurrently involved in or participated in another randomized clinical trial within 30 days prior to enrollment in this study.

• Patients who are pregnant or planning to become pregnant within the duration of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Price Vision Group	Indianapolis	Indiana	United States	46260

Sponsors and Collaborators

• Cornea Research Foundation of America

Investigators

• Principal Investigator: Francis W Price, Jr., MD, Price Vision Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cornea Research Foundation of America
• ClinicalTrials.gov Identifier: NCT01853696
• Other Study ID Numbers: 2013-0424
• First Posted: May 15, 2013
• Last Update Posted: May 15, 2015
• Last Verified: Apr 1, 2015

• Additional relevant MeSH terms: Corneal Edema; Fuchs' Endothelial Dystrophy; Loteprednol Etabonate; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

Participant Flow

Arm/Group Title	Loteprednol	Prednisolone Acetate
Arm/Group Description	Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months loteprednol etabonate 0.5% gel	Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months prednisolone acetate 1%
Period Title: Overall Study
STARTED	84	83
COMPLETED	78	78
NOT COMPLETED	6	5

Baseline Characteristics

Arm/Group Title	Loteprednol	Prednisolone Acetate	Total
Arm/Group Description	Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months loteprednol etabonate	Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months prednisolone acetate 1%	Total of all reporting groups
Overall Participants	84	83	167
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	69	69	69
Sex: Female, Male (Count of Participants)
Female	56 66.7%	61 73.5%	117 70.1%
Male	28 33.3%	22 26.5%	50 29.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	1 1.2%	1 0.6%
White	84 100%	82 98.8%	166 99.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	84 100%	83 100%	167 100%

Outcome Measures

1. Primary Outcome

Title	Intraocular Pressure
Description	Number of eyes in which the absolute intraocular pressure equaled or exceeded 24 mm Hg OR in which there was a relative increase of at least 10 mm Hg over the baseline preoperative reading.
Time Frame	from 1 to 12 months after transplant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Loteprednol	Prednisolone Acetate
Arm/Group Description	Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months loteprednol etabonate 0.5% gel	Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months prednisolone acetate 1%
Measure Participants	84	83
Measure eyes	116	116
Number [eyes]	11	27

2. Secondary Outcome

Title	Immunologic Graft Rejection Episode
Description	Rejection episodes were assessed by slit lamp examination and categorized as definite when an endothelial rejection line was detected in a previously clear graft, probable when inflammation (stromal infiltrate, keratic precipitates, cells in the anterior chamber, or ciliary injection) was detected in a previously clear graft without an endothelial rejection line, and possible if central corneal pachymetry increased by 30 microns or more, even if the cornea was clear and no inflammation was detected by slit lamp examination.
Time Frame	within first year after cornea transplantation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Loteprednol	Prednisolone Acetate
Arm/Group Description	Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months loteprednol etabonate 0.5% gel	Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months prednisolone acetate 1%
Measure Participants	84	83
Measure eyes	116	116
Number [eyes]	0	0

Adverse Events

Time Frame	11 months study duration
Arm/Group Title	Loteprednol		Prednisolone Acetate
Arm/Group Description	Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months loteprednol etabonate 0.5% gel		Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months prednisolone acetate 1%
All Cause Mortality
	Loteprednol		Prednisolone Acetate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Loteprednol		Prednisolone Acetate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/84 (0%)		0/83 (0%)
Other (Not Including Serious) Adverse Events
	Loteprednol		Prednisolone Acetate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/84 (0%)		0/83 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.