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

72 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Loteprednol Etabonate Ophthalmic Gel [Lotemax] for reducing post-injection pain in age-related macular degeneration?

Loteprednol Etabonate Ophthalmic Gel has been shown to effectively reduce inflammation and pain after eye surgeries, such as cataract surgery, by improving drug delivery and penetration into eye tissues. This suggests it may also help with pain after eye injections, like those used in age-related macular degeneration. ^{1 2 3 4 5}

Is Loteprednol safe for treating post-injection pain in age-related macular degeneration?

Loteprednol etabonate, used in eye gel form, has been shown to be safe and well-tolerated for treating inflammation and pain after eye surgery, with a low risk of increasing eye pressure. In clinical trials, side effects were rare and included mild issues like eye discomfort or swelling. This suggests it is generally safe for use in humans. ^{1 2 4 5 6}

How does the drug loteprednol differ from other treatments for post-injection pain in age-related macular degeneration?

Loteprednol is a corticosteroid that is used in a gel form with submicron particle size, which improves its delivery and penetration into eye tissues, requiring less of the drug to be effective. This formulation is unique compared to other treatments as it is specifically designed to reduce inflammation and pain with minimal impact on eye pressure and vision. ^{1 2 3 5 7}

What is the purpose of this trial?

Patients are already receiving an intravitreal injection as a standard of care, but they are consenting to receiving a loteprednol drop following the intravitreal injection. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. As of now, there is no definitive pain management technique following intravitreal injections. Loteprednol is a corticosteroid widely used in ophthalmology to treat pain and inflammation, however, it has not been studied as a treatment for pain following intravitreal injections. Our overall goal is to manage pain to improve quality of care after intravitreal injections. Participants will be given either loteprednol, or artificial tears following one visit for an intravitreal injection to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at three different times over a 1-week period. Artificial tear and medication usage will also be tracked over a 1-week period.

Research Team

Vishak John, MD

Principal Investigator

Vistar Eye Center

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

Principal Investigator

Vistar Eye Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 0.5% 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 (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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Loteprednol Etabonate (Submicron) Ophthalmic Gel 0.38%: A Review in Post-Operative Inflammation and Pain Following Ocular Surgery. [2021]

2. United States 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation effectiveness of 0.1% nepafenac on injection-related pain in patients undergoing intravitreal Ozurdex injection. [2022]

4. New Zealand 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. [2022]

5. New Zealand 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. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

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

7. New Zealand 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. [2022]