Loteprednol vs. Prednisolone and Fluorometholone

Sponsor
University of Utah (Other)
Overall Status
Completed
CT.gov ID
NCT03123614
Collaborator
(none)
131
Enrollment
1
Location
2
Arms
45.4
Actual Duration (Months)
2.9
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • Drug: Loteprednol Etabonate 0.5% Oph Gel
  • Drug: Prednisolone Acetate 1% Oph Susp
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
131 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Examiners are masked to the treatment arm when obtaining measurements of intraocular pressure (IOP) and grading corneal haze.
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Loteprednol 0.5% Gel for Routine Prophylaxis After Photorefractive Keratectomy Compared to Prednisolone Acetate 1% Suspension and Fluorometholone 0.1% Suspension
Actual Study Start Date :
Sep 19, 2014
Actual Primary Completion Date :
Jul 1, 2018
Actual Study Completion Date :
Jul 1, 2018

Arms and Interventions

ArmIntervention/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

  1. 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

  1. Number of Eyes With Corneal Haze [12 months]

    As determined by slit lamp examination

  2. Uncorrected Visual Acuity [3 months]

    Best uncorrected visual acuity will be measured at 3 months

  3. Best Corrected Visual Acuity at 3 Months [3 months]

    Best uncorrected visual acuity will be measured at 3 months

Eligibility Criteria

Criteria

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

SiteCityStateCountryPostal Code
1Moran Eye Center - Midvalley LocationMurrayUtahUnited States84107

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.
Responsible Party:
Mark Mifflin, Professor, Ophthalmology/Visual Sciences, University of Utah
ClinicalTrials.gov Identifier:
NCT03123614
Other Study ID Numbers:
  • IRB # 75978
First Posted:
Apr 21, 2017
Last Update Posted:
May 26, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Mark Mifflin, Professor, Ophthalmology/Visual Sciences, University of Utah
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleLoteprednol Etabonate 0.5% Oph GelPrednisolone Acetate 1% Oph Susp
Arm/Group DescriptionGroup 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 GelGroup 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
STARTED5774
COMPLETED5774
NOT COMPLETED00

Baseline Characteristics

Arm/Group TitleLoteprednol Etabonate 0.5% Oph GelPrednisolone Acetate 1% Oph SuspTotal
Arm/Group DescriptionGroup 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 GelGroup 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 SuspTotal of all reporting groups
Overall Participants5774131
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

1. Primary Outcome
TitleChange in Intraocular Pressure (IOP) From Baseline Through Month 3
DescriptionIntraocular pressure will be measured by applanation tonometry
Time FrameBaseline, 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 TitleLoteprednol Etabonate 0.5% Oph GelPrednisolone Acetate 1% Oph Susp
Arm/Group DescriptionGroup 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 GelGroup 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 Participants5774
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)
2. Secondary Outcome
TitleNumber of Eyes With Corneal Haze
DescriptionAs determined by slit lamp examination
Time Frame12 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleLoteprednol Etabonate 0.5% Oph GelPrednisolone Acetate 1% Oph Susp
Arm/Group DescriptionGroup 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 GelGroup 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 Participants5774
Measure Eyes114147
Count of Units [Eyes]
3
7
3. Secondary Outcome
TitleUncorrected Visual Acuity
DescriptionBest uncorrected visual acuity will be measured at 3 months
Time Frame3 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleLoteprednol Etabonate 0.5% Oph GelPrednisolone Acetate 1% Oph Susp
Arm/Group DescriptionGroup 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 GelGroup 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 Participants5774
Mean (Standard Deviation) [logMAR]
-0.078
(0.10)
-0.075
(0.09)
4. Secondary Outcome
TitleBest Corrected Visual Acuity at 3 Months
DescriptionBest uncorrected visual acuity will be measured at 3 months
Time Frame3 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleLoteprednol Etabonate 0.5% Oph GelPrednisolone Acetate 1% Oph Susp
Arm/Group DescriptionGroup 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 GelGroup 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 Participants5774
Mean (Standard Deviation) [logMAR]
-0.120
(0.059)
-0.114
(0.03)

Adverse Events

Time Frame3 years and 10 months
Adverse Event Reporting Description
Arm/Group TitleLoteprednol Etabonate 0.5% Oph GelPrednisolone Acetate 1% Oph Susp
Arm/Group DescriptionGroup 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 GelGroup 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 GelPrednisolone Acetate 1% Oph Susp
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/57 (0%) 0/74 (0%)
Serious Adverse Events
Loteprednol Etabonate 0.5% Oph GelPrednisolone Acetate 1% Oph Susp
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/57 (0%) 0/74 (0%)
Other (Not Including Serious) Adverse Events
Loteprednol Etabonate 0.5% Oph GelPrednisolone Acetate 1% Oph Susp
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total3/57 (5.3%) 7/74 (9.5%)
Eye disorders
Non-visually significant corneal haze3/57 (5.3%) 37/74 (9.5%) 7

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.

Results Point of Contact

Name/TitleMark Mifflin, MD
OrganizationUniversity of Utah Moran Eye Center
Phone801-213-4152
EmailMark.Mifflin@hsc.utah.edu
Responsible Party:
Mark Mifflin, Professor, Ophthalmology/Visual Sciences, University of Utah
ClinicalTrials.gov Identifier:
NCT03123614
Other Study ID Numbers:
  • IRB # 75978
First Posted:
Apr 21, 2017
Last Update Posted:
May 26, 2021
Last Verified:
May 1, 2021