CLINICAL TRIALS PROFILE FOR LATANOPROST

505(b)(2) Clinical Trials for LATANOPROST

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00402493 ↗	Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops	Completed	Pfizer	N/A	2006-12-01	The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.
OTC	NCT00402493 ↗	Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops	Completed	Philadelphia Eye Associates	N/A	2006-12-01	The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.
New Formulation	NCT03331770 ↗	Efficacy and Tolerability of an Innovative Formulation of BAK-free Latanoprost	Completed	Laboratorios Poen	Phase 4	2017-01-06	This study evaluates the efficacy and tolerability of a new formulation of latanoprost without Benzalkonium Chloride (BAK-free). Patients with open-angle glaucoma who were using BAK-containing latanoprost ophthalmic solution for ≥6 months, switched to BAK-free latanoprost ophthalmic emulsion.

All Clinical Trials for LATANOPROST

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00051142 ↗	A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)	Completed	Alcon Research	Phase 3	2001-02-01	The purpose of this study is to evaluate the safety and IOP-lowering efficacy of Travoprost (0.004%) compared to Latanoprost (0.005%) in patients with chronic open-angle glaucoma or ocular hypertension.
NCT00051181 ↗	A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Chronic Angle-Closure Glaucoma	Completed	Alcon Research	Phase 3	2000-01-01	To demonstrate that the intraocular pressure(IOP)-lowering efficacy of Travoprost (0.004%) is equal or better than that of Latanoprost 0.005% in patients with chronic angle-closure glaucoma.
NCT00140049 ↗	A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma	Completed	Pfizer	Phase 4	2005-07-01	To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.
NCT00140049 ↗	A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 4	2005-07-01	To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.
NCT00143208 ↗	Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.	Completed	Pfizer	Phase 4	2003-05-01	This study is designed as an open label evaluation of the efficacy of latanoprost and timolol fixed combination (Xalacom) after 6 month of treatment. Eligible patients may be enrolled at the baseline visit. All current ocular hypotensive therapy must be discontinued at this time. On baseline day, patients eligible for the study will receive Xalacom which is to be instilled in the morning.
NCT00143208 ↗	Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 4	2003-05-01	This study is designed as an open label evaluation of the efficacy of latanoprost and timolol fixed combination (Xalacom) after 6 month of treatment. Eligible patients may be enrolled at the baseline visit. All current ocular hypotensive therapy must be discontinued at this time. On baseline day, patients eligible for the study will receive Xalacom which is to be instilled in the morning.

Clinical Trial Conditions for LATANOPROST

Condition Name

Condition Name for LATANOPROST
Intervention	Trials
Ocular Hypertension	106
Glaucoma	70
Open-Angle Glaucoma	24
Open Angle Glaucoma	20

Condition MeSH

Condition MeSH for LATANOPROST
Intervention	Trials
Glaucoma	161
Ocular Hypertension	133
Glaucoma, Open-Angle	113
Hypertension	98

Clinical Trial Locations for LATANOPROST

Trials by Country

Trials by Country for LATANOPROST
Location	Trials
United States	415
Italy	15
Canada	14
Greece	12
Japan	12

Trials by US State

Trials by US State for LATANOPROST
Location	Trials
California	45
Texas	34
Georgia	27
New York	26
North Carolina	22

Clinical Trial Progress for LATANOPROST

Clinical Trial Phase

Clinical Trial Phase for LATANOPROST
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	2
PHASE2	5

Clinical Trial Status

Clinical Trial Status for LATANOPROST
Clinical Trial Phase	Trials
Completed	135
Recruiting	22
Unknown status	21

Clinical Trial Sponsors for LATANOPROST

Sponsor Name

Sponsor Name for LATANOPROST
Sponsor	Trials
Pfizer	23
Alcon Research	15
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	14

Sponsor Type

Sponsor Type for LATANOPROST
Sponsor	Trials
Industry	157
Other	107
NIH	2

Latanoprost Clinical Trials Update, Market Analysis, and Projection

Last updated: April 24, 2026

What is latanoprost and why does it still matter commercially?

Latanoprost is a prostaglandin F2α analog used for lowering intraocular pressure (IOP) in glaucoma and ocular hypertension. From a market perspective, it remains a high-volume, long-established therapy with continued demand driven by chronic use, entrenched prescribing, and ongoing competition from branded and generic prostaglandin analogs and combination products.

What does the clinical-trials landscape show for latanoprost right now?

Latanoprost is mature and widely available, so new trials are typically incremental: formulation, dosing convenience, pediatric extrapolation/label expansion, device-adjunct studies, switching studies, or comparative effectiveness in real-world relevant settings.

Clinical trials update (type of activity observed in registries and publications)

• Formulation and delivery refinement: studies comparing preservative-free vs preserved products and/or alternative drop regimens.
• Comparative effectiveness: head-to-head or add-on studies versus other prostaglandin analogs and fixed combinations.
• Population expansion: trials that enroll broader age ranges (including pediatric subsets where permitted) under IOP endpoint frameworks.
• Adherence and switching: studies that measure IOP control after regimen change to improve persistence.

Clinical endpoints that dominate latanoprost studies

• Primary: change in IOP from baseline (often diurnal IOP, mean IOP, or eye-specific IOP).
• Secondary: proportion achieving target IOP, ocular tolerability, adverse event rates, and visual function assessments where applicable.

What to track as the practical “signal”

• Any trial that changes the route or frequency (dose regimen) or claims improved tolerability without compromising IOP control.
• Any trial designed to support label language around special populations, or conversion to once-daily convenience strategies that can shift share within prostaglandin classes.

How is latanoprost used in current glaucoma therapy pathways?

Latanoprost sits at or near first-line in many markets due to efficacy, once-daily dosing, and long safety record. In practice, therapy flows through:

• Monotherapy prostaglandin analog selection
• Escalation to fixed combinations if target IOP is not met
• Switching within prostaglandin analog class for tolerability or adherence
• Add-on therapy for incomplete IOP control

This matters for market projection because it determines whether new competitive entries can displace latanoprost volume or only carve share into higher-acuity segments.

How big is the latanoprost market and what drives demand?

The global glaucoma and ocular hypertension market is driven by:

• Aging demographics
• High prevalence and underdiagnosis
• Chronic lifelong therapy in diagnosed patients
• Ongoing need for treatment adherence and tolerability
• Escalation dynamics from monotherapy to combination regimens

Latanoprost’s demand driver is the same:

• Once-daily chronic use
• Low clinician switching friction within prostaglandin analog class
• Generic competition pressure that keeps prices low, but volume high

Pricing and segment dynamics

• Generic latitude dominates pricing over time.
• Branded products tend to defend share through differentiated formulations (such as preservative-free), dosing convenience, or bundled patient-assistance infrastructure where relevant.
• Fixed combinations can shift utilization from mono prostaglandin drops to combination products, impacting unit share for individual molecules.

Who competes with latanoprost most directly?

The competitive set includes:

• Other prostaglandin F2α analogs: travoprost, bimatoprost, tafluprost, unoprostone (where marketed)
• Fixed combinations that include a prostaglandin analog plus an additional IOP-lowering agent
• Emerging/regional branded formulations and preservative-free variants that can win patients with intolerance

Commercial implication Competition is less about new clinical endpoints and more about:

• Tolerability differences (hyperemia, eyelash changes, periorbital effects)
• Formulation differences (preservative-free)
• Convenience and adherence
• Insurance formularies and switching programs

What is the current regulatory and patent reality for latanoprost?

Latanoprost is long off primary discovery exclusivity in most major markets, so protection is less about molecule patents and more about:

• Later-use patents (if any remain in specific jurisdictions)
• Formulation and method-of-use claims
• Device-related claims (where applicable)

This structure supports ongoing generic penetration and limits pricing power. It shifts revenue growth to unit volume durability, defensible formulation niches, and combination uptake dynamics.

What do market projections likely look like?

Given:

• Established clinical role
• Generic penetration
• Mature competitive set
• Chronic indication structure

Projection shape

• Volume: likely stable to modest growth in diagnosed treated populations, offset by substitution into fixed combinations and treatment switching within prostaglandin classes.
• Value: modest growth or flat to low single-digit depending on region and mix, because generic price compression typically outpaces volume gains.

Three-scenario projection framework (directional)	Scenario	Unit volume trend	Price trend	Revenue trend	Primary driver
Base case	Stable to low growth	Low single-digit erosion	Flat to low growth	Aging demand offsets combination substitution
Upside	Moderate volume gain	Slower price erosion	Low-to-mid growth	Preservative-free/formulation differentiation wins switching
Downside	Volume declines modestly	Faster erosion	Flat to decline	Fixed combination adoption accelerates and formulary restriction tightens

Where does latanoprost still earn incremental share?

Incremental share usually comes from one of four pathways:

• Switching from other prostaglandins due to tolerability or perceived IOP stability
• Preservative-free transitions for sensitive patients or long-term tolerability management
• Adherence-led conversion if regimen convenience or patient support improves persistence
• Regional formulary inclusion that sustains utilization despite low unit margins

What should a business investor or R&D sponsor monitor next?

For a molecule-level asset this mature, the monitor list is short:

• New formulation approvals or label expansions by region that can shift payer decisions
• Comparative trials that influence guideline committee preferences or prescribing behavior
• Fixed-combination competitive moves that reduce monotherapy share
• Pediatric policy updates that affect coverage for prostaglandin analogs

Key product and pipeline indicators to map to latanoprost outcomes

Indicator set

• IOP control benchmarks: mean diurnal IOP change and proportion reaching target thresholds
• Safety and tolerability: rates of conjunctival hyperemia, ocular irritation, and discontinuation
• Adherence proxies: persistence, refill adherence, or switch-back rates
• Formulary status: tier placement, prior authorization requirements, and contract pharmacy outcomes

Key Takeaways

• Latanoprost is a mature prostaglandin analog with chronic, high-volume demand and limited molecule-level patent runway in most markets.
• Clinical trial activity is typically incremental and dominated by formulation, tolerability, and comparative effectiveness rather than paradigm-changing outcomes.
• Market value is constrained by generic price compression; future performance depends on maintaining unit volume via adherence and tolerability advantages, and resisting substitution into fixed combinations.
• Practical upside is tied to preservative-free or differentiated formulations and payer-friendly positioning; downside risks are faster fixed-combination adoption and formulary restriction.

FAQs

1. Is latanoprost still actively studied in clinical trials?
   Yes, activity is concentrated in formulation, tolerability, switching, and comparative studies rather than new mechanism or large-scale breakthrough indications.

2. What outcomes matter most in latanoprost trials?
   IOP reduction (often mean diurnal IOP) and tolerability metrics such as hyperemia and discontinuation rates.

3. What drives latanoprost market growth: volume or price?
   Volume is the main driver; price is typically pressured by generic competition, limiting revenue growth.

4. How does fixed-combination therapy affect latanoprost share?
   It can reduce monotherapy unit share when clinicians escalate patients to combination regimens after inadequate IOP control.

5. Where can latanoprost still differentiate commercially?
   Formulation choices that improve tolerability (such as preservative-free positioning) and payer-compatible access strategies.

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Latanoprost (product and labeling information). FDA. https://www.accessdata.fda.gov/
[2] European Medicines Agency. (n.d.). Latanoprost (public assessment/EPAR information where applicable). EMA. https://www.ema.europa.eu/
[3] International Council of Ophthalmology / standard glaucoma care references and prostaglandin analog guideline frameworks. (n.d.). Glaucoma treatment guidance (prostaglandin analog role in IOP lowering). https://www.icoph.org/