Loteprednol vs. Prednisolone and Fluorometholone
Study Details
Study Description
Brief Summary
Corneal haze, in which the cornea becomes cloudy, is a well-known and a potentially vision-threatening postoperative complication of photorefractive keratectomy (PRK). Topical ophthalmic corticosteroids are routinely prescribed by most surgeons postoperatively to help prevent this complication.
Goals of topical steroids use after PRK include effective modulation of the healing response to prevent corneal haze while at the same time minimizing side effects, such as intraocular pressure elevation or cataract formation. Loteprednol etabonate is a corticosteroid that exerts its therapeutic effects and is then quickly changed into inactive metabolites. This relatively fast metabolism of loteprednol gives it a lower side effect profile than other steroids, including a smaller effect on intraocular pressure. In the ophthalmic literature, there is currently no consensus on a standard regimen or which type of corticosteroid should be used after PRK.
Investigators are conducting a prospective, randomized trial to compare the incidence of intraocular pressure rise and visually significant postoperative corneal haze after PRK with the use of loteprednol 0.5% gel compared to the use of earlier generation steroids, prednisolone acetate 1% suspension and fluorometholone 0.1% suspension.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Loteprednol Etabonate 0.5% Oph Gel Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response. |
Drug: Loteprednol Etabonate 0.5% Oph Gel
|
Active Comparator: Prednisolone acetate 1% Oph Susp Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response. |
Drug: Prednisolone Acetate 1% Oph Susp
|
Outcome Measures
Primary Outcome Measures
- Change in Intraocular Pressure (IOP) From Baseline Through Month 3 [Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op]
Intraocular pressure will be measured by applanation tonometry
Secondary Outcome Measures
- Number of Eyes With Corneal Haze [12 months]
As determined by slit lamp examination
- Uncorrected Visual Acuity [3 months]
Best uncorrected visual acuity will be measured at 3 months
- Best Corrected Visual Acuity at 3 Months [3 months]
Best uncorrected visual acuity will be measured at 3 months
Eligibility Criteria
Criteria
Inclusion Criteria:
-
All subjects who are deemed suitable candidates for PRK after routine refractive surgery screening will be considered eligible for participation in this study.
-
Subjects must be at least 21 years of age and not pregnant or nursing (due to fluctuations in visual parameters during pregnancy).
Exclusion Criteria:
- Selection will be consistent with the current standard of care for PRK. Any patient that is not a suitable candidate for PRK will not be included.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Moran Eye Center - Midvalley Location | Murray | Utah | United States | 84107 |
Sponsors and Collaborators
- University of Utah
Investigators
- Principal Investigator: Mark Mifflin, MD, University of Utah Moran Eye Center
Study Documents (Full-Text)
More Information
Publications
None provided.- IRB # 75978
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Loteprednol Etabonate 0.5% Oph Gel | Prednisolone Acetate 1% Oph Susp |
---|---|---|
Arm/Group Description | Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response. Loteprednol Etabonate 0.5% Oph Gel | Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response. Prednisolone Acetate 1% Oph Susp |
Period Title: Overall Study | ||
STARTED | 57 | 74 |
COMPLETED | 57 | 74 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Loteprednol Etabonate 0.5% Oph Gel | Prednisolone Acetate 1% Oph Susp | Total |
---|---|---|---|
Arm/Group Description | Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response. Loteprednol Etabonate 0.5% Oph Gel | Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response. Prednisolone Acetate 1% Oph Susp | Total of all reporting groups |
Overall Participants | 57 | 74 | 131 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
57
100%
|
74
100%
|
131
100%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
34.6
(8.8)
|
35.3
(6.2)
|
35.0
(7.3)
|
Sex: Female, Male (Count of Participants) | |||
Female |
24
42.1%
|
36
48.6%
|
60
45.8%
|
Male |
33
57.9%
|
38
51.4%
|
71
54.2%
|
Race and Ethnicity Not Collected (Count of Participants) | |||
Count of Participants [Participants] |
0
0%
|
||
Region of Enrollment (Count of Participants) | |||
United States |
57
100%
|
74
100%
|
131
100%
|
Intraocular Pressure (mmHg) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [mmHg] |
14.38
(2.11)
|
14.30
(2.13)
|
14.34
(2.12)
|
Outcome Measures
Title | Change in Intraocular Pressure (IOP) From Baseline Through Month 3 |
---|---|
Description | Intraocular pressure will be measured by applanation tonometry |
Time Frame | Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Loteprednol Etabonate 0.5% Oph Gel | Prednisolone Acetate 1% Oph Susp |
---|---|---|
Arm/Group Description | Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response. Loteprednol Etabonate 0.5% Oph Gel | Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response. Prednisolone Acetate 1% Oph Susp |
Measure Participants | 57 | 74 |
Baseline intraocular pressure (IOP) |
14.38
(2.11)
|
14.30
(2.13)
|
IOP 1 week postop |
13.67
(2.34)
|
13.28
(3.37)
|
IOP 1 month postop |
14.15
(2.88)
|
14.60
(4.20)
|
IOP 2 months postop |
13.36
(2.53)
|
13.16
(2.80)
|
IOP 3 months postop |
13.15
(2.43)
|
12.22
(2.38)
|
Title | Number of Eyes With Corneal Haze |
---|---|
Description | As determined by slit lamp examination |
Time Frame | 12 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Loteprednol Etabonate 0.5% Oph Gel | Prednisolone Acetate 1% Oph Susp |
---|---|---|
Arm/Group Description | Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response. Loteprednol Etabonate 0.5% Oph Gel | Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response. Prednisolone Acetate 1% Oph Susp |
Measure Participants | 57 | 74 |
Measure Eyes | 114 | 147 |
Count of Units [Eyes] |
3
|
7
|
Title | Uncorrected Visual Acuity |
---|---|
Description | Best uncorrected visual acuity will be measured at 3 months |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Loteprednol Etabonate 0.5% Oph Gel | Prednisolone Acetate 1% Oph Susp |
---|---|---|
Arm/Group Description | Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response. Loteprednol Etabonate 0.5% Oph Gel | Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response. Prednisolone Acetate 1% Oph Susp |
Measure Participants | 57 | 74 |
Mean (Standard Deviation) [logMAR] |
-0.078
(0.10)
|
-0.075
(0.09)
|
Title | Best Corrected Visual Acuity at 3 Months |
---|---|
Description | Best uncorrected visual acuity will be measured at 3 months |
Time Frame | 3 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Loteprednol Etabonate 0.5% Oph Gel | Prednisolone Acetate 1% Oph Susp |
---|---|---|
Arm/Group Description | Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response. Loteprednol Etabonate 0.5% Oph Gel | Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response. Prednisolone Acetate 1% Oph Susp |
Measure Participants | 57 | 74 |
Mean (Standard Deviation) [logMAR] |
-0.120
(0.059)
|
-0.114
(0.03)
|
Adverse Events
Time Frame | 3 years and 10 months | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Loteprednol Etabonate 0.5% Oph Gel | Prednisolone Acetate 1% Oph Susp | ||
Arm/Group Description | Group 1 will use loteprednol 0.5% gel in both eyes, starting at a frequency of four times per day for the first week and then tapered off based on clinical judgement of the corneal healing response. Loteprednol Etabonate 0.5% Oph Gel | Group 2 will use prednisolone acetate 1% suspension in both eyes, starting at a frequency of four times per day for the first week, then tapered down to a regimen of fluorometholone 0.1% suspension, which will then be tapered off based on clinical judgement of the corneal healing response. Prednisolone Acetate 1% Oph Susp | ||
All Cause Mortality |
||||
Loteprednol Etabonate 0.5% Oph Gel | Prednisolone Acetate 1% Oph Susp | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/57 (0%) | 0/74 (0%) | ||
Serious Adverse Events |
||||
Loteprednol Etabonate 0.5% Oph Gel | Prednisolone Acetate 1% Oph Susp | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/57 (0%) | 0/74 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Loteprednol Etabonate 0.5% Oph Gel | Prednisolone Acetate 1% Oph Susp | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 3/57 (5.3%) | 7/74 (9.5%) | ||
Eye disorders | ||||
Non-visually significant corneal haze | 3/57 (5.3%) | 3 | 7/74 (9.5%) | 7 |
Limitations/Caveats
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.
Results Point of Contact
Name/Title | Mark Mifflin, MD |
---|---|
Organization | University of Utah Moran Eye Center |
Phone | 801-213-4152 |
Mark.Mifflin@hsc.utah.edu |
- IRB # 75978