CompletedNCT03123614Updated May 26, 2021Results posted

Loteprednol vs. Prednisolone and Fluorometholone

A Phase 4 interventional study of Loteprednol Etabonate 0.5% Oph Gel and Prednisolone Acetate 1% Oph Susp in Intraocular Pressure and Corneal Opacity, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-05-26.

Sponsored by University of Utah · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 131
Allocation: Randomized
Ages: 21 Years and older
Sex: All

Study 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.

Conditions studied

Intraocular Pressure
Corneal Opacity

Browse trials for

Corneal Opacity 31

Keywords

Photorefractive keratectomy

Who can participate

Ages eligible: 21 Years and older
Sexes eligible: 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

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.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 131 participants (actual)

Study arms

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

Interventions

DrugLoteprednol Etabonate 0.5% Oph Gel
DrugPrednisolone Acetate 1% Oph Susp

What researchers measure

Primary outcomes

Change in Intraocular Pressure (IOP) From Baseline Through Month 3
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

Secondary outcomes

Number of Eyes With Corneal Haze
As determined by slit lamp examination
Time frame: 12 months
Uncorrected Visual Acuity
Best uncorrected visual acuity will be measured at 3 months
Time frame: 3 months
Best Corrected Visual Acuity at 3 Months
Best uncorrected visual acuity will be measured at 3 months
Time frame: 3 months

Results

Posted Dec 21, 2020

Participant flow

Participant flow — Overall Study
Milestone	Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp
Started	57	74
Completed	57	74
Not completed	0	0

Outcome measures

PrimaryChange in Intraocular Pressure (IOP) From Baseline Through Month 3

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
Reported as:: Mean · mmHg

Change in Intraocular Pressure (IOP) From Baseline Through Month 3
mmHg	Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp
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

SecondaryNumber of Eyes With Corneal Haze

As determined by slit lamp examination

Time frame:: 12 months
Reported as:: Count of units · Eyes

Number of Eyes With Corneal Haze
Eyes	Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp
Number of Eyes With Corneal Haze	3	7

SecondaryUncorrected Visual Acuity

Best uncorrected visual acuity will be measured at 3 months

Time frame:: 3 months
Reported as:: Mean · logMAR

Uncorrected Visual Acuity
logMAR	Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp
Uncorrected Visual Acuity	-0.078 ± 0.10	-0.075 ± 0.09

SecondaryBest Corrected Visual Acuity at 3 Months

Best uncorrected visual acuity will be measured at 3 months

Time frame:: 3 months
Reported as:: Mean · logMAR

Best Corrected Visual Acuity at 3 Months
logMAR	Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp
Best Corrected Visual Acuity at 3 Months	-0.120 ± 0.059	-0.114 ± 0.03

Adverse events

Collected over 3 years and 10 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Loteprednol Etabonate 0.5% Oph Gel	0/57 (0%)	0/57 (0%)	3/57 (5.3%)
Prednisolone Acetate 1% Oph Susp	0/74 (0%)	0/74 (0%)	7/74 (9.5%)

Most frequent other events

Most frequent other events
Event	Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp
Non-visually significant corneal hazeEye disorders	3/57	7/74

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp	Total
<=18 years	0	0	0
Between 18 and 65 years	57	74	131
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp	Total
Mean	34.6 ± 8.8	35.3 ± 6.2	35.0 ± 7.3

Sex: Female, Male
Sex: Female, Male(Participants)	Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp	Total
Female	24	36	60
Male	33	38	71

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp	Total
Count of participants	—	—	0

Region of Enrollment
Region of Enrollment(Participants)	Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp	Total
United States	57	74	131

Intraocular Pressure
Intraocular Pressure(mmHg)	Loteprednol Etabonate 0.5% Oph Gel	Prednisolone Acetate 1% Oph Susp	Total
Mean	14.38 ± 2.11	14.30 ± 2.13	14.34 ± 2.12

Study locations

1 site

Moran Eye Center - Midvalley Location
Murray, Utah 84107, United States

References and documents

Study documents

Protocol and statistical analysis plan · Jul 27, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03123614
Lead sponsor: University of Utah
Responsible party: Mark Mifflin (Professor, Ophthalmology/Visual Sciences, University of Utah) — Principal investigator
First posted: Apr 21, 2017
Start date: Sep 19, 2014
Primary completion: Jul 2018
Completion: Jul 2018
Results posted: Dec 21, 2020
Last update: May 26, 2021

Study contacts

Mark Mifflin, MD

principal investigator · University of Utah Moran Eye Center

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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