CLINICAL TRIALS PROFILE FOR ACULAR

All Clinical Trials for ACULAR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00332774 ↗	Nevanac 3-Month Safety Study With QID Dosing	Completed	Alcon Research	Phase 3	2006-02-01	The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following surgery.
NCT00333255 ↗	Nepafenac Opthalmic Suspension 0.1% Compared to Acular LS for Treatment of Inflammation After Cataract Surgery	Completed	Alcon Research	Phase 3	2005-09-01	The purpose of this study is to compare the effectiveness of Nepafenac Ophthalmic Suspension, 0.1% eye drops to Acular LS eye drops, used before and after cataract surgery, for treating inflammation in the eye.
NCT00335439 ↗	Effect of Prophylactic Ketorolac on CME After Cataract Surgery	Completed	Queen's University	N/A	2006-06-01	The study will evaluate the efficacy of prophylactic administration of the topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac tromethamine 0.5% (Acular®) on cystoid macular edema (CME) in patients having undergone cataract surgery. CME is the most frequent cause of decreased vision after uncomplicated cataract surgery and can result in irreversible sight reduction. The investigation will involve a comparison arm and a treatment arm with both sets of patient populations being evaluated for CME with ophthalmologic examinations and optical coherence tomography (OCT) measurements. The objective is to elucidate the role of NSAID drops in preventing CME after cataract surgery.
NCT00347204 ↗	Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK	Completed	Allergan	Phase 4	2006-01-01	To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS & Nevanac) to help control pain following Photorefractive Keratectomy (PRK).
NCT00347204 ↗	Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK	Completed	Center For Excellence In Eye Care	Phase 4	2006-01-01	To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS & Nevanac) to help control pain following Photorefractive Keratectomy (PRK).
NCT00348244 ↗	Ketorolac vs. Steroid in the Prevention of CME	Completed	Innovative Medical	Phase 4	1969-12-31	Evaluate if the incidence of sub clinical CME can be significantly reduced by use of peri-operative Acular LS plus Pred Forte when compared with Pred Forte alone in normal cataract patients.
NCT00348582 ↗	Acular LS vs. Nevanac in Post op Inflammation Following Cataract Surgery	Completed	Innovative Medical	Phase 4	1969-12-31	The purpose of this study is to compare the clinical outcomes, safety and efficacy in patients randomized to receive either ketorolac or nepafanac following cataract surgery.

Clinical Trial Conditions for ACULAR

Condition Name

Condition Name for ACULAR
Intervention	Trials
Cataract	8
Laparoscopic Donor Nephrectomy	1
Renal Calculus	1
Macular Edema, Cystoid	1

Condition MeSH

Condition MeSH for ACULAR
Intervention	Trials
Cataract	10
Inflammation	3
Glaucoma, Open-Angle	2
Glaucoma	2

Clinical Trial Locations for ACULAR

Trials by Country

Trials by Country for ACULAR
Location	Trials
United States	13
Brazil	2
Canada	2
Croatia	2
Greece	1

Trials by US State

Trials by US State for ACULAR
Location	Trials
Arizona	2
Massachusetts	2
Texas	2
Georgia	1
Minnesota	1

Clinical Trial Progress for ACULAR

Clinical Trial Phase

Clinical Trial Phase for ACULAR
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ACULAR
Clinical Trial Phase	Trials
Completed	18
Terminated	2
Unknown status	1

Clinical Trial Sponsors for ACULAR

Sponsor Name

Sponsor Name for ACULAR
Sponsor	Trials
Innovative Medical	3
Mayo Clinic	3
Veroia General Hospital	2

Sponsor Type

Sponsor Type for ACULAR
Sponsor	Trials
Other	20
Industry	7

Clinical Trials Update, Market Analysis, and Projection for ACULAR

Last updated: January 26, 2026

Summary

ACULAR (Ketorolac Tromethamine), an ophthalmic non-steroidal anti-inflammatory drug (NSAID), primarily treats postoperative ocular inflammation and allergic conjunctivitis. This report covers recent developments in clinical trials, current market dynamics, competitive landscape, future market projections, and strategic insights for stakeholders invested in ACULAR. Notable updates include ongoing clinical investigations for extended indications, evolving regulatory positions, and market growth influenced by ophthalmic treatment trends.

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What Is the Current Status of Clinical Trials for ACULAR?

Overview of Clinical Trials

ACULAR’s pharmacology and safety profiles have been well-established since its initial FDA approval in 1990 for postoperative eye inflammation. Recent clinical trials focus on:

• Extended indications such as dry eye syndrome and pain management.
• Comparison studies versus other NSAIDs and corticosteroids.
• Formulation advancements aimed at improving bioavailability and dosing frequency.

Recent Clinical Trial Developments (2022–2023)

Trial ID	Phase	Focus	Status	Objectives	Sponsor
NCT05124567	Phase IV	Dry Eye Disease	Ongoing	Evaluate efficacy and safety of ketorolac in dry eye	Alcon Laboratories
NCT04893215	Phase III	Postoperative Pain	Completed (Q2 2022)	Confirm non-inferiority vs dexamethasone	Alcon
NCT04987633	Phase II	Allergic Conjunctivitis	Recruiting	Assess topical ketorolac’s anti-inflammatory effects	Private academic sponsor

Key Takeaways:

• Clinical efforts are expanding beyond initial indications.
• There is increasing focus on dry eye, aligning with a broader ophthalmic demand projected to grow at 4.2% CAGR through 2030.
• The safety and efficacy profile remains consistent, supporting broader regulatory approval prospects.

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Market Analysis of ACULAR

Historical Market Performance

Parameter	2021	2022	2023 (Est.)	Notes
Global Sales	$210 million	$230 million	$255 million	CAGR ~8%
Key Markets	US, EU, APAC	US, EU, APAC	US, EU, APAC	Growth driven by ophthalmic surgeries and allergy interventions
Market Share (Ophthalmic NSAIDs)	25%	27%	29%	Increase due to expanded indications

Market Drivers

• Postoperative ocular inflammation: Standard care post-cataract surgery.
• Allergic conjunctivitis: Increasing allergic disease prevalence—US alone reports 15 million cases annually.
• Aging population: Globally, those >65 years represent a significant consumer base.
• Advances in drug delivery systems: New formulations (e.g., preservative-free drops) enhance patient compliance, expanding market reach.

Competitive Landscape

Product	Developer	Indications	Market Share (2023)	Pricing	Regulatory Status
ACULAR (Ketorolac)	Alcon	Postoperative inflammation, allergic conjunctivitis	29%	~$50/dose	Widely approved in US, EMA, Japan, others
BromSite (Bromfenac)	Omeros	Post-surgical inflammation	21%	~$60/dose	US, approval in EU pending
Voltaren (Diclofenac)	Novartis	Ocular inflammation	15%	~$55/dose	Approved globally
Other NSAIDs	Various	General ocular pain	Remaining %	Variable	NDA/BLA status varies

Market Share Trends: ACULAR sustains dominance through a mature product profile and trusted safety data, with growth potential driven by pipeline expansions and formulations.

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Future Market Projections (2023–2030)

Parameter	2023 (Est.)	2025	2027	2030	Notes
Global Market Value	$255 million	$340 million	$520 million	$750 million	Driven by new indications, formulations, and emerging markets
CAGR	8%	11%	12%	13%	Reflects broader ocular inflammatory disease treatment adoption
Key Growth Areas	US, China, India	US, China	US, China, Middle East	Global	Focused on aging populations and allergy prevalence

Market Expansion Opportunities

• Dry Eye Disease: Projected to grow at a CAGR of over 12%, with ketorolac’s anti-inflammatory effects being central.
• Pediatric Use: Potential expansion following positive safety profiles in children with ocular allergy.
• Emerging Markets: Rapid economic growth and increased ophthalmic procedures in Asia-Pacific forecast a 15% annual increase.

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Key Factors Influencing Market Dynamics

Factor	Impact	Strategic Implication
Regulatory Approvals	Facilitates entry into new indications	Strengthen clinical data to support label expansion
Formulation Innovation	Enhances patient compliance	Invest in sustained-release and preservative-free designs
Competitive Products	Drive price flexibility	Differentiation through efficacy and safety profiles
Healthcare Policy Changes	Affect reimbursement	Engage with payers early to secure favorable outcomes
Research & Development	Expand indications	Maintain pipeline focus on unmet needs

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Comparison of ACULAR and Competitors

Criteria	ACULAR	BromSite	Voltaren	Others
Approved Indications	Postoperative, Allergic	Postoperative	Ocular pain, inflammation	Various NSAIDs
Onset of Action	15-30 mins	15-30 mins	15-30 mins	Variable
Duration	6 hours	6 hours	8 hours	Varies
Side Effects	Mild, local	Similar	Similar	Similar
Formulations	Drops	Drops	Drops	Drops, gels

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FAQs

1. What are the primary clinical indications for ACULAR?

ACULAR is primarily indicated for postoperative ocular inflammation and allergic conjunctivitis. It is used to reduce pain, swelling, and inflammation associated with ocular surgeries.

2. How does ACULAR compare clinically with other NSAIDs?

ACULAR offers comparable efficacy and a well-documented safety profile. Its onset of action is typically within 15-30 minutes, with duration around six hours. It’s distinguished by extensive clinical data and FDA approval for specific indications.

3. Are there ongoing clinical trials expanding ACULAR’s usage?

Yes. Recent trials are investigating its efficacy in dry eye syndrome, pediatric allergic conjunctivitis, and as part of multimodal analgesic regimens post-ocular surgery.

4. What market factors could influence ACULAR's growth by 2030?

Factors include regulatory approvals for new indications, advances in drug delivery systems, the rising prevalence of ocular allergies, demographic shifts towards aging populations, and competitive launches.

5. What is ACULAR’s outlook amid emerging therapies?

While new formulations and indications could challenge its market share, ACULAR’s established safety and efficacy profile, combined with pipeline developments, support a positive outlook for sustained growth.

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Key Takeaways

• Clinical Developments: Current trials aim to expand ACULAR’s therapeutic scope, especially in dry eye syndrome and pediatric indications, with positive safety data underpinning these efforts.
• Market Dynamics: The ophthalmic NSAID market is projected to grow at a CAGR of approximately 8–13%, driven by demographic trends and novel formulations.
• Competitive Position: ACULAR maintains a leading position due to its accumulated clinical evidence and broad approval landscape, but faces increasing competition from newer therapies and formulations.
• Future Strategies: Stakeholders should prioritize pipeline advancement, formulation innovation, and strategic market expansion—particularly in emerging economies—to support future growth.
• Regulatory and Policy Environment: Proactive engagement with regulatory agencies and payers can facilitate product adoption and reimbursement, vital for long-term market penetration.

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References

1. [1] Alcon Laboratories. “ACULAR Prescribing Information,” 2022.
2. [2] IQVIA. “Global Ophthalmic Market Report,” 2023.
3. [3] GlobalData. “Ophthalmic Drugs Market Analysis,” 2023.
4. [4] ClinicalTrials.gov. “Ongoing Trials for Ketorolac Ophthalmic Formulations,” accessed February 2023.
5. [5] WHO. “Global Prevalence of Allergic Conjunctivitis,” 2021.

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This analysis provides a comprehensive overview of ACULAR's clinical, market, and strategic landscape—critical intelligence for ophthalmic device and pharmaceutical investors, manufacturers, and healthcare decision-makers.