Intraocular PressurePhase 4NCT03123614
Loteprednol vs. Prednisolone and Fluorometholone
A Phase 4 study testing Loteprednol Etabonate 0.5% Oph Gel and Prednisolone Acetate 1% Oph Susp in people with Intraocular Pressure and Corneal Opacity, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Intraocular Pressure, Corneal Opacity
- What is being tested?
- Loteprednol Etabonate 0.5% Oph Gel and Prednisolone Acetate 1% Oph Susp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2014to Jul 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Moran Eye Center - Midvalley Location
Murray, Utah, 84107
About this study
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
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
- Intraocular Pressure, Corneal Opacity
- Being tested
- Loteprednol Etabonate 0.5% Oph Gel, Prednisolone Acetate 1% Oph Susp
- Keywords
- Photorefractive keratectomy
- Medical subject headings
- Corneal Opacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loteprednol Etabonate 0.5% Oph GelDrug
Prednisolone Acetate 1% Oph SuspDrug
| Study group | Role | What they receive |
|---|---|---|
| Loteprednol Etabonate 0.5% Oph Gel | Active comparator | 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. Receives: Drug: Loteprednol Etabonate 0.5% Oph Gel |
| Prednisolone acetate 1% Oph Susp | Active comparator | 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. Receives: Drug: Prednisolone Acetate 1% Oph Susp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure (IOP) From Baseline Through Month 3
Intraocular pressure will be measured by applanation tonometry
Measured: Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op
Secondary outcomes (3)
Number of Eyes With Corneal Haze
As determined by slit lamp examination
Measured: 12 months
Uncorrected Visual Acuity
Best uncorrected visual acuity will be measured at 3 months
Measured: 3 months
Best Corrected Visual Acuity at 3 Months
Best uncorrected visual acuity will be measured at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start19 Sep 2014
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Mifflin, University of Utah
- Investigators
- Mark Mifflin, MD, Principal investigator, University of Utah Moran Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123614
- Sponsor's protocol ID
- IRB # 75978
- Status last verified
- May 2021
- First submitted
- 17 Apr 2017
- Last updated
- 26 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03123614
- Acronym / sponsor ID
- IRB # 75978
- Conditions
- Intraocular Pressure, Corneal Opacity
- Keywords
- Photorefractive keratectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 19 Sep 2014 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Posted 21 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loteprednol Etabonate 0.5% Oph Gel | Active comparator | Drug: Loteprednol Etabonate 0.5% Oph GelGroup 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. |
| Prednisolone acetate 1% Oph Susp | Active comparator | Drug: Prednisolone Acetate 1% Oph SuspGroup 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loteprednol Etabonate 0.5% Oph Gel | Drug | Loteprednol Etabonate 0.5% Oph Gel |
| Prednisolone Acetate 1% Oph Susp | Drug | Prednisolone acetate 1% Oph Susp |
Primary outcome
Change in Intraocular Pressure (IOP) From Baseline Through Month 3
Time frame: 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
3 secondary outcomes
Number of Eyes With Corneal Haze
Time frame: 12 months
Uncorrected Visual Acuity
Time frame: 3 months
Best Corrected Visual Acuity at 3 Months
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Mifflin, MD principal investigator
University of Utah Moran Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Loteprednol Etabonate 0.5% Oph Gel and Prednisolone Acetate 1% Oph Susp in people with Intraocular Pressure and Corneal Opacity, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intraocular Pressure (IOP) From Baseline Through Month 3 (time frame: Baseline, 1 week post-op, 1 month post-op, 2 months post-op, 3 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.