Loteprednol for Post-Injection Pain in Age-Related Macular Degeneration

Overseen By Paul K Varghese

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Must not be taking: Topical NSAIDs, Steroids

Disqualifiers: Dementia, Chronic pain, Glaucoma, others

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a drop of loteprednol, a corticosteroid commonly used to reduce eye pain and inflammation, can manage pain after an eye injection for age-related macular degeneration. Participants will receive either a drop of loteprednol or a drop of artificial tears immediately after their standard eye injection. The researchers aim to determine if loteprednol reduces pain more effectively than artificial tears. Individuals with age-related macular degeneration who receive regular eye injections may qualify for this study, provided they do not have other eye conditions causing pain or certain allergies. As an unphased trial, this study offers an opportunity to contribute to understanding new pain management options for eye injections.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using topical NSAIDs or steroids.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that loteprednol etabonate gel, used for eye treatments, is generally well-tolerated. In studies involving patients who underwent eye surgery, very few side effects occurred. Less than 1% of patients experienced issues such as eye irritation. Importantly, it did not significantly increase eye pressure, a common concern with some eye treatments. These findings suggest that loteprednol is safe for ocular use, making it a promising option for managing pain after eye injections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for post-injection pain in age-related macular degeneration involve general anti-inflammatory or pain-relief medications. Loteprednol Etabonate, however, is unique because it's a corticosteroid specifically formulated as an ophthalmic gel, which may offer more targeted relief directly to the eye area. Researchers are excited about Loteprednol because it might reduce inflammation effectively right after the injection, potentially leading to quicker pain relief compared to standard anti-inflammatory drops. This specific targeting and rapid action are what set Loteprednol apart from current options.

What evidence suggests that loteprednol could be an effective treatment for post-injection pain in age-related macular degeneration?

Research has shown that loteprednol etabonate eye gel effectively reduces eye inflammation and pain after cataract surgery. Studies have found that using it as an eye drop significantly alleviates post-surgery pain. In this trial, one treatment arm will receive loteprednol etabonate to assess its effectiveness for pain after injections into the eye, although researchers have not specifically tested it for this purpose before. Its success in similar cases suggests potential benefits. Loteprednol is a corticosteroid, which reduces inflammation and pain by calming the body's immune response, making it a promising option for managing pain after eye procedures. ^{1 2 3 4 6}

Who Is on the Research Team?

Vishak John, MD

Principal Investigator

Vistar Eye Center

Romulo Albuquerque, M.D., Ph.D.

Principal Investigator

Vistar Eye Center

Are You a Good Fit for This Trial?

This trial is for adults with age-related macular degeneration who are getting intravitreal injections. They must not have dementia, report baseline eye pain, use certain eye medications, be under 18, have specific eye conditions like advanced glaucoma or a history of pressure increases due to steroids, allergies to study drugs, chronic pain disorders, herpes zoster; they also can't be pregnant or incarcerated.

Inclusion Criteria

I have age-related macular degeneration and am receiving eye injections as treatment.

Exclusion Criteria

I am unable to give my consent for medical procedures.

My condition is advanced glaucoma.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive an intravitreal injection followed by either loteprednol or artificial tears

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and medication usage over a 1-week period

1 week

3 phone calls

What Are the Treatments Tested in This Trial?

Interventions

• Loteprednol Etabonate Ophthalmic Gel [Lotemax]
• Nepafenac Ophthalmic 0.3% Ophthalmic Suspension
• Refresh Lubricant Eye Drops [Artificial Tears]

Trial Overview The trial tests if loteprednol (a corticosteroid) drops can reduce pain after intravitreal injections compared to artificial tears. Participants will receive one of the treatments and report their pain levels over a week via phone calls.

How Is the Trial Designed?

Group I: Loteprednol Experimental Treatment 1 Intervention

1 drop of Loteprednol is administered immediately after the intravitreal injection in this treatment arm.

Group II: Artificial tears Placebo Group 1 Intervention

1 drop of artificial tears is administered immediately after the intravitreal injection in this treatment arm. This arm acts as a negative control.

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Vistar Eye Center

Collaborator

Trials

1

Recruited

70+

Vistar Eye Center

Collaborator

Trials

1

Recruited

70+

Published Research Related to This Trial

In a study involving 406 patients after cataract surgery, the new gel formulation of loteprednol etabonate 0.5% significantly improved the resolution of inflammation and pain compared to a placebo, with 30.5% of patients achieving complete resolution of inflammation and 72.9% reporting no pain by day 8.

The treatment was found to be safe, with only one patient in each group experiencing a significant increase in intraocular pressure, and over 85% of patients reported no discomfort during drop instillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of loteprednol etabonate 0.5% gel in the treatment of ocular inflammation and pain after cataract surgery. Rajpal, RK., Roel, L., Siou-Mermet, R., et al.[2022]

In a study of 59 patients undergoing intravitreal Ozurdex injection, the use of topical 0.1% nepafenac significantly reduced pain compared to a placebo, with a median pain score of 2 versus 4 (p < 0.001).

The findings suggest that topical 0.1% nepafenac provides an additive analgesic effect when used alongside standard topical anesthesia, enhancing patient comfort during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation effectiveness of 0.1% nepafenac on injection-related pain in patients undergoing intravitreal Ozurdex injection. Ogurel, T., Ogurel, R., Ozkal, F., et al.[2022]

Loteprednol etabonate (LE) ophthalmic gel 0.5% maintains consistent drug concentrations regardless of whether the bottle is shaken before use, achieving a mean concentration of 102% of the declared amount over a 2-week period.

In contrast, both Prednisolone acetate suspensions showed significant variability in drug concentrations when not shaken, which could lead to under- or overdosing, potentially affecting treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose uniformity of loteprednol etabonate ophthalmic gel (0.5%) compared with branded and generic prednisolone acetate ophthalmic suspension (1%). Marlowe, ZT., Davio, SR.[2021]

In a study involving 189 LASIK and 209 PRK eyes, loteprednol etabonate ophthalmic gel 0.5% was found to be safe and well-tolerated, with no significant increases in intraocular pressure (IOP) post-surgery.

The gel effectively managed postoperative pain and inflammation, with mean uncorrected distance visual acuity of 20/24 for LASIK and 20/30 for PRK, indicating good visual outcomes after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective analysis of the postoperative use of loteprednol etabonate gel 0.5% following laser-assisted in situ keratomileusis or photorefractive keratectomy surgery. Salinger, CL., Gordon, M., Jackson, MA., et al.[2022]

Loteprednol etabonate ophthalmic gel 0.5% is effective and well-tolerated for treating post-operative inflammation and pain after cataract surgery, based on clinical trials lasting 14 days.

The gel formulation offers advantages over previous forms, such as uniform dosing without shaking, a pH close to natural tears, and a low risk of increasing intraocular pressure, making it a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loteprednol etabonate ophthalmic gel 0.5%: a review of its use in post-operative inflammation and pain following ocular surgery. Lyseng-Williamson, KA.[2021]

Loteprednol etabonate ophthalmic ointment 0.5% significantly improved outcomes in patients after cataract surgery, with 27.7% achieving complete resolution of inflammation compared to 12.5% in the vehicle group, and 75.5% reporting no pain versus 43.1% in the vehicle group by day 8.

The ointment was well tolerated, with fewer patients experiencing ocular adverse events (47.2% for LE ointment vs. 78.0% for vehicle) and a lower need for rescue medication, indicating its safety and efficacy in managing postoperative inflammation and pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery. Comstock, TL., Paterno, MR., Singh, A., et al.[2022]

Loteprednol etabonate ophthalmic gel 0.38% is effective in significantly reducing ocular inflammation and pain after cataract surgery, with complete resolution observed in more patients compared to a placebo by day 8, and pain relief noted as early as day 3.

The gel formulation has a lower incidence of treatment-related ocular adverse events (less than 1%) and does not significantly affect intraocular pressure or visual acuity, making it a safe option for post-operative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loteprednol Etabonate (Submicron) Ophthalmic Gel 0.38%: A Review in Post-Operative Inflammation and Pain Following Ocular Surgery. Kang, C., Keam, SJ., Shirley, M., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-macular-degeneration-9-2022-98391

Loteprednol for Post-Injection Pain in Age-Related Macular ... Loteprednol etabonate ophthalmic gel 0.38% is effective in significantly reducing ocular inflammation and pain after cataract surgery, with complete resolution ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7736007/

Loteprednol Etabonate (Submicron) Ophthalmic Gel 0.38% Loteprednol etabonate gel 0.38% was well tolerated in patients with post-operative ocular inflammation and pain following cataract surgery, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07090044

NCT07090044 | Comparing Post-intravitreal Injection Pain ... Loteprednol etabonate ophthalmic gel 0.38% is a steroidal drug to be administered as a topical drop in the eye receiving the standard of care ...

4. pi.bausch.com pi.bausch.com/globalassets/pdf/news-archive/bauschhealthpdf/11-01-2021-110226760.pdf

Bausch + Lomb Will Present Scientific Data and ... LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% is a corticosteroid indicated for the treatment of post-operative inflammation and pain ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6683659/

Loteprednol etabonate (submicron) ophthalmic gel 0.38 ... In both studies, LE gel 0.38% administered TID was safe and effective in the treatment of ocular inflammation and pain following cataract ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2019/208219Orig1s000MedR.pdf

Clinical Review(s) - accessdata.fda.gov Loteprednol etabonate (LE) is a corticosteroid that was originally developed as a topical ophthalmic suspension 0.5% (Lotemax).