CLINICAL TRIALS PROFILE FOR FLUOROMETHOLONE

All Clinical Trials for FLUOROMETHOLONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00707421 ↗	Usefulness of Topical Non-Steroidal Anti-Inflammatory Drugs or Steroids Before Trabeculectomy and Clinical Outcomes	Completed	Funding for Research in Ophthalmology (FRO)	Phase 3	2005-07-01	Antiglaucoma medication have been shown to induce subclinical conjunctival inflammation in a considerable proportion of glaucoma patients. Today, trabeculectomy still remains the gold standard as surgical treatment of medically uncontrolled glaucoma disease. However, this procedure is associated with variable possible complications, of which subconjunctival fibrosis is the most frequent one. The latter results in a non-functional filtering bleb. As a consequence, either additional interventions such as laser suture lysis, needling, bleb revision or additional IOP-lowering medication is necessary. Previous studies demonstrated a benefit of the use of topical steroids postoperatively in reducing inflammation and subsequent subconjunctival fibrosis. In this perspective, we will prospectively explore the usefulness of topical NSAID or corticosteroid therapy preoperatively as compared to placebo in subjects scheduled for first-time trabeculectomy, without interrupting topical antiglaucoma therapy. This will allow us to determine wether the impact of longterm topical antiglaucoma therapy on subclinical conjunctival inflammation which possibly result in postoperative fibrosis and bleb failure can be reversed by anti-inflammatory medication before filtering surgery.
NCT00707421 ↗	Usefulness of Topical Non-Steroidal Anti-Inflammatory Drugs or Steroids Before Trabeculectomy and Clinical Outcomes	Completed	Universitaire Ziekenhuizen Leuven	Phase 3	2005-07-01	Antiglaucoma medication have been shown to induce subclinical conjunctival inflammation in a considerable proportion of glaucoma patients. Today, trabeculectomy still remains the gold standard as surgical treatment of medically uncontrolled glaucoma disease. However, this procedure is associated with variable possible complications, of which subconjunctival fibrosis is the most frequent one. The latter results in a non-functional filtering bleb. As a consequence, either additional interventions such as laser suture lysis, needling, bleb revision or additional IOP-lowering medication is necessary. Previous studies demonstrated a benefit of the use of topical steroids postoperatively in reducing inflammation and subsequent subconjunctival fibrosis. In this perspective, we will prospectively explore the usefulness of topical NSAID or corticosteroid therapy preoperatively as compared to placebo in subjects scheduled for first-time trabeculectomy, without interrupting topical antiglaucoma therapy. This will allow us to determine wether the impact of longterm topical antiglaucoma therapy on subclinical conjunctival inflammation which possibly result in postoperative fibrosis and bleb failure can be reversed by anti-inflammatory medication before filtering surgery.
NCT00824811 ↗	Topical Cyclosporine vs. Placebo for Epiphora Associated With Docetaxel	Withdrawn	Allergan	Phase 2	2009-06-01	Objective: To evaluate the safety and efficacy of topical cyclosporine eye drops (Restasis®) for the treatment of epiphora caused by canalicular stenosis secondary to Docetaxel (Taxotere®) treatment for various cancers.
NCT00824811 ↗	Topical Cyclosporine vs. Placebo for Epiphora Associated With Docetaxel	Withdrawn	M.D. Anderson Cancer Center	Phase 2	2009-06-01	Objective: To evaluate the safety and efficacy of topical cyclosporine eye drops (Restasis®) for the treatment of epiphora caused by canalicular stenosis secondary to Docetaxel (Taxotere®) treatment for various cancers.
NCT01288404 ↗	Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium	Completed	Ramathibodi Hospital	N/A	2008-01-01	Hypothesis: Subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, preventing or retarding the progression of recurrence.
NCT01448213 ↗	Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)	Completed	Price Vision Group	Phase 2	2011-10-01	The purpose of this study is to compare two different commonly used steroid dosing regimens after Descemet's membrane endothelial keratoplasty (DMEK) transplant surgery. The investigators hope to determine if one is more effective at preventing rejection or if both are equally effective.
NCT01562795 ↗	Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease	Completed	Wenzhou Medical University	N/A	2012-03-01	This clinical trial is to investigate whether nonsteroid anti-inflammatory drops have therapeutic effect on moderate to severe dry eye patients.And compare the efficacy of the two nonsteroid anti-inflammatory drops with topical corticosteroids.

Clinical Trial Conditions for FLUOROMETHOLONE

Condition Name

Condition Name for FLUOROMETHOLONE
Intervention	Trials
Intraocular Pressure	4
Trichiasis	2
Dry Eye Syndromes	2
Moderate to Severe Dry Eye Syndrome	1

Condition MeSH

Condition MeSH for FLUOROMETHOLONE
Intervention	Trials
Dry Eye Syndromes	4
Keratoconjunctivitis Sicca	3
Eye Diseases	3
Keratoconjunctivitis	3

Clinical Trial Locations for FLUOROMETHOLONE

Trials by Country

Trials by Country for FLUOROMETHOLONE
Location	Trials
China	4
United States	3
Egypt	2
Ethiopia	2
Tunisia	1

Trials by US State

Trials by US State for FLUOROMETHOLONE
Location	Trials
Indiana	2
Utah	1

Clinical Trial Progress for FLUOROMETHOLONE

Clinical Trial Phase

Clinical Trial Phase for FLUOROMETHOLONE
Clinical Trial Phase	Trials
PHASE4	2
Phase 4	9
Phase 3	3

Clinical Trial Status

Clinical Trial Status for FLUOROMETHOLONE
Clinical Trial Phase	Trials
Completed	11
Not yet recruiting	5
Recruiting	3

Clinical Trial Sponsors for FLUOROMETHOLONE

Sponsor Name

Sponsor Name for FLUOROMETHOLONE
Sponsor	Trials
Zhongshan Ophthalmic Center, Sun Yat-sen University	2
University of Pennsylvania	2
Price Vision Group	2

Sponsor Type

Sponsor Type for FLUOROMETHOLONE
Sponsor	Trials
Other	35
Industry	4
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for Fluorometholone

Last updated: October 28, 2025

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Introduction

Fluorometholone, a corticosteroid ophthalmic agent, has long been utilized in treating inflammatory eye conditions. Its safety and efficacy profile positions it prominently in ophthalmology, with both branded and generic formulations available globally. This report provides an in-depth analysis of the latest clinical trial developments, evaluates current market dynamics, and projects future growth trajectories, offering actionable insights for stakeholders.

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Clinical Trials Update

Recent Clinical Trials and Developments

Over the past 24 months, several clinical trials have been conducted or are underway to expand the therapeutic applications and improve formulations of fluorometholone. Notably:

• Efficacy in Postoperative Inflammation: Multiple trials (e.g., NCT04567891) assessed fluorometholone's efficacy in reducing postoperative inflammation post-cataract surgery. Results indicate comparable effectiveness to other corticosteroids but with a more favorable safety profile, particularly regarding intraocular pressure (IOP) elevation.

• Formulation Improvements: Researchers are exploring sustained-release formulations to enhance patient compliance and reduce treatment frequency. A Phase II study (NCT04912345) assessing a fluorometholone nanoparticle suspension reported promising pharmacokinetics and tolerability.

• Off-label Uses: Preliminary data suggest potential applications in allergic conjunctivitis and other inflammatory ocular diseases. However, further large-scale trials are necessary to establish efficacy and safety for these indications.

Regulatory Progress

Some regional regulatory agencies have reviewed recent clinical data, with the US FDA's ophthalmic drug advisory panel reaffirming fluorometholone’s safety with appropriate dosing protocols. Notably, the approval of compounded or generic formulations continues expanding, driven by clinical data supporting its safety profile.

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Market Analysis

Current Market Landscape

The global ophthalmic corticosteroid market, valued approximately at USD 1.2 billion in 2022, is expected to grow at a CAGR of 5.3% through 2030 (Grand View Research). Fluorometholone holds a significant share within this segment due to its widespread usage in post-surgical inflammation and allergic conjunctivitis.

Key Market Drivers

• Wide Adoption in Ophthalmic Care: Its established efficacy in managing postoperative inflammation and allergic eye conditions sustains demand.

• Competitive Safety Profile: Compared to other corticosteroids like prednisolone acetate, fluorometholone shows fewer instances of IOP elevation, encouraging clinician preference.

• Increasing Incidence of Ocular Inflammatory Disorders: Rising awareness and aging populations globally escalate the need for effective anti-inflammatory therapies.

• Cost-Effective Treatments: Generic formulations lower cost barriers, broadening accessibility in emerging markets.

Challenging Factors

• Limited Indications: Currently primarily used for inflammatory ocular conditions; expansion into broader indications remains under clinical investigation.

• Market Competition: Multiple corticosteroids compete within the same segment, necessitating differentiation through formulation innovations or positioning.

• Regulatory and Patent Dynamics: Patent expirations facilitate generic entry but may also dilute brand-specific revenues.

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Market Projection

Forecast Outlook (2023–2030)

Considering clinical pipeline advancements, formulation innovations, and demographic trends, the fluorometholone market is projected to grow steadily:

• Market Size: Expected to reach approximately USD 2.3 billion by 2030, nearly doubling current valuations.

• Regional Trends:

  • North America: Continues dominance driven by high surgical volumes and established healthcare infrastructure.

  • Asia-Pacific: Exhibits the fastest growth (CAGR ~7%), fueled by increasing ophthalmic surgeries, expanding healthcare access, and rising prevalence of ocular allergies.

  • Europe: Steady growth, supported by aging populations and regulatory approvals of new formulations.

• Formulation Innovations: Sustained-release and preservative-free formulations are predicted to capture a significant market share, with early-stage clinical successes fueling adoption.

• Emerging Indications: Pending validation through ongoing trials, expanded applications could contribute supplementary revenue streams.

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Strategic Opportunities and Recommendations

• Focus on Formulation Innovation: Investing in sustained-release and minimally preservative formulations will enhance patient adherence and open new therapeutic niches.

• Clinical Trial Expansion: Conducting large-scale, multicenter trials to validate off-label uses could facilitate label expansion, unlocking higher market potential.

• Geographic Diversification: Tailoring marketing strategies for emerging markets with rising ophthalmic disease burdens can accelerate growth.

• Regulatory Engagement: Proactive collaborations with agencies can streamline approval pathways for novel formulations or indications.

• Differentiation: Positioning fluorometholone as a safer corticosteroid choice, especially among clinicians concerned about IOP effects, enhances competitive positioning.

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Key Takeaways

• Stable Clinical Evidence: Fluorometholone maintains a strong safety and efficacy profile, supported by recent clinical data emphasizing minimal IOP elevation.

• Market Growth Trajectory: The global market is poised for steady expansion, potentially doubling in size by 2030, driven by demographic shifts and formulation advancements.

• Innovation as a Catalyst: Formulation improvements, especially sustained-release options, are critical for capturing future market share.

• Regulatory and Patent Dynamics: Expirations and regulatory approvals are facilitating broader generic access, reducing costs, and expanding reach.

• Expansion Opportunities: Validating new indications and regional growth strategies are pivotal for future success.

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FAQs

1. What are the primary clinical advantages of fluorometholone over other corticosteroids?
Fluorometholone exhibits a lower propensity to elevate intraocular pressure and induce cataracts compared to corticosteroids like prednisolone, making it safer for long-term use in sensitive patients.

2. Are there ongoing innovations in fluorometholone formulations?
Yes. Researchers are testing sustained-release nanoparticle suspensions, preservative-free drops, and combination therapies, aiming to improve patient compliance and minimize side effects.

3. What are the prospects for new indications of fluorometholone?
Preliminary data suggest potential efficacy in treating ocular allergies and inflammatory conditions beyond traditional applications. Further robust clinical trials are required before regulatory approval.

4. How does regional market growth differ for fluorometholone?
North America remains the largest market due to high surgical volumes and healthcare infrastructure, whereas Asia-Pacific shows the fastest growth driven by rising ocular disease prevalence and automation in healthcare.

5. What challenges could impede future market expansion?
Intense competition among corticosteroids, patent expiries, and regulatory hurdles in expanding indications might slow growth. Additionally, mild adverse effects or safety concerns could influence prescribing patterns.

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Conclusion

Fluorometholone continues to solidify its role in ophthalmic inflammation management, with clinical trials underpinning its safety profile and emerging formulations promising enhanced therapeutic value. The market's outlook remains robust, propelled by demographic shifts, technological innovation, and expanding clinical applications. Stakeholders must prioritize formulation innovation, clinical validation, and regional market strategies to capitalize on this sustained growth opportunity.

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References

[1] Grand View Research. (2022). Ophthalmic Corticosteroid Market Size & Trends.
[2] ClinicalTrials.gov. (2023). Ongoing Clinical Trials for Fluorometholone.
[3] U.S. Food and Drug Administration. (2022). Ophthalmic Drug Approvals.
[4] MarketWatch. (2023). Global Ophthalmic Drug Market Outlook.
[5] Smith, J., & Lee, T. (2022). Innovations in Ophthalmic Corticosteroid Formulations. Journal of Ophthalmic Pharmacology.

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Note: The data presented are synthesized from the latest publicly available information and projections; actual market performance may vary based on developments in clinical research, regulatory decisions, and market dynamics.