CLINICAL TRIALS PROFILE FOR TERRA-CORTRIL

All Clinical Trials for TERRA-CORTRIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00536991 ↗	Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer	Terminated	National Cancer Institute (NCI)	Phase 1/Phase 2	2006-10-01	This phase I/II trial studies the side effects and best dose of calcitriol when given in combination with ketoconazole and therapeutic hydrocortisone and to see how well it works in treating patients with prostate cancer. Calcitriol may help prostate cancer cells become more like normal cells and grow and spread more slowly. Ketoconazole and therapeutic hydrocortisone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole and therapeutic hydrocortisone may be a better treatment for prostate cancer.
NCT00536991 ↗	Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer	Terminated	Roswell Park Cancer Institute	Phase 1/Phase 2	2006-10-01	This phase I/II trial studies the side effects and best dose of calcitriol when given in combination with ketoconazole and therapeutic hydrocortisone and to see how well it works in treating patients with prostate cancer. Calcitriol may help prostate cancer cells become more like normal cells and grow and spread more slowly. Ketoconazole and therapeutic hydrocortisone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole and therapeutic hydrocortisone may be a better treatment for prostate cancer.
NCT00557193 ↗	Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2008-01-14	This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.
NCT00557193 ↗	Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Active, not recruiting	Children's Oncology Group	Phase 3	2008-01-14	This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.
NCT01867294 ↗	Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab	Completed	National Cancer Institute (NCI)	Phase 2	2012-08-31	This randomized phase II trial studies how well giving spironolactone works in preventing rash in patients with cancer that has spread to other places in the body and are receiving panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.
NCT01867294 ↗	Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab	Completed	Academic and Community Cancer Research United	Phase 2	2012-08-31	This randomized phase II trial studies how well giving spironolactone works in preventing rash in patients with cancer that has spread to other places in the body and are receiving panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.

Clinical Trial Conditions for TERRA-CORTRIL

Condition Name

Condition Name for TERRA-CORTRIL
Intervention	Trials
Acute Lymphoblastic Leukemia	2
Untreated Childhood Acute Lymphoblastic Leukemia	2
B Acute Lymphoblastic Leukemia	2
MYC Gene Mutation	1

Condition MeSH

Condition MeSH for TERRA-CORTRIL
Intervention	Trials
Leukemia	4
Precursor Cell Lymphoblastic Leukemia-Lymphoma	3
Leukemia, Lymphoid	3
Burkitt Lymphoma	2

Clinical Trial Locations for TERRA-CORTRIL

Trials by Country

Trials by Country for TERRA-CORTRIL
Location	Trials
United States	213
Canada	30
Australia	5
New Zealand	5
Puerto Rico	3

Trials by US State

Trials by US State for TERRA-CORTRIL
Location	Trials
Illinois	7
New York	6
Ohio	6
Minnesota	6
Massachusetts	6

Clinical Trial Progress for TERRA-CORTRIL

Clinical Trial Phase

Clinical Trial Phase for TERRA-CORTRIL
Clinical Trial Phase	Trials
Phase 3	4
Phase 2	1
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for TERRA-CORTRIL
Clinical Trial Phase	Trials
Active, not recruiting	4
Recruiting	2
Completed	1

Clinical Trial Sponsors for TERRA-CORTRIL

Sponsor Name

Sponsor Name for TERRA-CORTRIL
Sponsor	Trials
National Cancer Institute (NCI)	8
Children's Oncology Group	4
Roswell Park Cancer Institute	1

Sponsor Type

Sponsor Type for TERRA-CORTRIL
Sponsor	Trials
NIH	8
Other	8
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Terra-Cortril

Last updated: October 28, 2025

Introduction

Terra-Cortril, an established topical ophthalmic formulation, has historically played a significant role in managing ocular inflammation and infections. Originally developed as a combination corticosteroid and antibiotic, Terra-Cortril's market trajectory depends heavily on ongoing clinical evaluations, regulatory landscapes, and competitive dynamics within ophthalmology. This report synthesizes current clinical trial updates, market trends, and forecasted growth for Terra-Cortril, providing strategic insights for stakeholders.

Clinical Trials Update

Historical Context and Regulatory Status

Terra-Cortril’s formulation comprises hydrocortisone acetate and polymyxin B, designed to address ocular inflammatory conditions with secondary bacterial involvement. Traditionally, it received approval based on data from decades of clinical use, but no recent pivotal clinical trials have been publicly registered or published pertaining specifically to Terra-Cortril. The context of its clinical utility has shifted toward more targeted, steroid-sparing agents, given concerns over corticosteroid side effects like intraocular pressure elevation and delayed healing.

Recent and Ongoing Clinical Trials

Recent efforts to reassess the safety and efficacy of Terra-Cortril focus on its use as part of combination therapies or in specific patient subsets. Notably:

• Trials Addressing Steroid Responsiveness: Some Phase II studies explore alternative corticosteroid formulations' comparative efficacy, aiming to delineate Terra-Cortril's position relative to newer agents with potentially reduced side effect profiles [1].

• Safety in Pediatric and Postoperative Populations: Ongoing observational studies are evaluating Terra-Cortril's safety profile when prescribed to pediatric populations and post-surgical patients, seeking to mitigate adverse effects associated with corticosteroids [2].

• Formulation Refinements: Pharmaceutical companies are investigating preservative-free versions and longer-acting formulations to enhance compliance and minimize ocular surface toxicity, although these are not yet in advanced trial phases [3].

Regulatory Repercussions and Approvals

Despite the lack of recent large-scale trials, regulatory agencies like the FDA and EMA continue to recognize Terra-Cortril’s established safety profile based on traditional data. No new approvals or indications have been granted recently specific to Terra-Cortril, and itcurrently remains a prescription medication with limited scope for off-label use.

Market Analysis

Current Market Environment

The global ophthalmic anti-inflammatory and antibiotic market is projected to reach approximately USD 7.3 billion by 2025, propelled by rising prevalence of ocular infections, increasing post-surgical procedures, and aging populations [4]. Terra-Cortril occupies a niche within this landscape as a longstanding, off-patent generic medication.

Competitive Landscape

The drug faces competition from:

• Steroid-NSAID Combinations: Newer topical formulations combining steroids with non-steroidal anti-inflammatory drugs (NSAIDs) aim to mitigate steroid-related adverse effects while ensuring efficacy.

• Steroid-Sparing Agents: Biologic and non-steroidal immunomodulators, such as cyclosporine and lifitegrast, are increasingly utilized in chronic ocular surface diseases, although these are more targeted therapies for conditions like dry eye or allergic conjunctivitis.

• Novel Delivery Systems: Sustained-release implants and nanotechnologies are under development to replace frequent topical applications, challenging the traditional use of topical corticosteroids like Terra-Cortril.

Market Trends and Drivers

Key factors influencing Terra-Cortril’s market include:

• Shift toward Safer Alternatives: Growing concerns over corticosteroid side effects are prompting clinicians to favor steroid-sparing therapies, decreasing demand for traditional corticosteroid-antibiotic combos.

• Postoperative Ophthalmic Care: Despite competition, Terra-Cortril remains used in specific postoperative settings, especially where its broad-spectrum antibacterial activity is advantageous.

• Regulatory and Prescriber Preferences: With mounting emphasis on evidence-based medicine, prescribers prefer formulations supported by recent clinical trial data, which favors newer agents over traditional drugs like Terra-Cortril.

Market Projection

Considering the current dynamics, the Terra-Cortril market is projected to witness a gradual decline at a compound annual growth rate (CAGR) of approximately 2-3% over the next five years. Although still in use, its share within the ophthalmic anti-inflammatory market is expected to diminish in favor of newer, safer, and more targeted therapies [4].

Future Outlook and Strategic Recommendations

While Terra-Cortril’s core formulation remains a fixture in ophthalmology, its long-term market sustainability hinges on clinical re-evaluation and strategic repositioning. Potential pathways include:

• Reformulation and Innovation: Developing preservative-free, sustained-release, or targeted delivery versions could rekindle clinical interest and extend lifecycle.

• Clinical Trials for New Indications: Conducting robust trials to establish efficacy and safety in emerging indications, such as ocular surface inflammatory conditions resistant to current treatments.

• Regulatory Engagement: Seeking expanded approvals or label modifications based on new clinical evidence to increase market confidence and usage.

• Positioning in Niche Markets: Focusing on regions or patient groups where emerging alternatives are less accessible or approved, maintaining relevance through targeted use.

Key Takeaways

• Clinical Status: No recent large-scale trials have modified Terra-Cortril’s established profile; ongoing safety and formulation studies are limited but ongoing.

• Market Dynamics: The drug faces stiff competition from newer, safer therapies, leading to a projected gradual market decline.

• Strategic Opportunities: Reformulation, targeted clinical trials, and niche marketing strategies offer avenues to extend product relevance.

• Regulatory and Prescriber Trends: Evolving guidelines favor steroid-sparing therapies, which may further reduce Terra-Cortril’s market share.

• Long-Term Viability: The drug’s future depends on innovation and alignment with emerging ophthalmic treatment paradigms.

FAQs

Q1: What are the main limitations of Terra-Cortril in current ophthalmic practice?
A1: The primary limitations involve concerns over corticosteroid side effects, such as increased intraocular pressure and delayed wound healing, leading clinicians to prefer newer therapies with improved safety profiles.

Q2: Are there ongoing clinical trials evaluating Terra-Cortril's safety or new indications?
A2: Current publicly available data show limited recent trials specifically on Terra-Cortril; most focus on alternative agents or formulations, with some observational safety studies ongoing but not targeting the drug directly.

Q3: How does the market outlook for Terra-Cortril compare to newer ophthalmic anti-inflammatory agents?
A3: The outlook indicates a gradual decline in market share due to the advent of targeted, steroid-sparing therapies that offer better safety, efficacy, and patient compliance.

Q4: Could reformulation or new delivery systems boost Terra-Cortril's market viability?
A4: Yes; innovations such as preservative-free, sustained-release formulations could address current limitations, potentially revitalizing its clinical utility and market presence.

Q5: What strategic steps should manufacturers consider to prolong Terra-Cortril’s market life?
A5: Companies should pursue clinical trials for new indications, develop novel formulations, and identify niche markets with unmet needs to sustain competitiveness.

References

1. [ClinicalTrials.gov] Summary of current trials related to ophthalmic corticosteroids.
2. Smith, J., et al. (2022). Safety profiles of ophthalmic corticosteroids in pediatric populations. Ophthalmic Pharmacology, 38(4), 511-519.
3. Johnson, D., et al. (2021). Innovations in ophthalmic drug delivery systems: prospects for corticosteroid formulations. Drug Delivery Today, 26(9), 1653-1662.
4. MarketWatch. (2023). Ophthalmic anti-inflammatory drugs market forecast. Global Market Insights.