CLINICAL TRIALS PROFILE FOR TRAVOPROST

505(b)(2) Clinical Trials for travoprost

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
New Formulation	NCT00670033 ↗	Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension	Completed	Alcon Research	Phase 2	2008-04-01	The purpose of this study was to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or ocular hypertension.
New Formulation	NCT01452009 ↗	Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%	Withdrawn	Alcon Research	Phase 3	2011-11-01	A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%
New Formulation	NCT01658839 ↗	Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients	Completed	Alcon Research	Phase 1	2013-01-01	The purpose of this study was to assess the safety and describe the steady-state plasma pharmacokinetic (PK) profiles of Travoprost ophthalmic solution, 0.004% (new formulation) following a once daily administration for 7 days in pediatric glaucoma or ocular hypertension patients.

All Clinical Trials for travoprost

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.
NCT00061503 ↗	Mechanism of Action of TRAVATAN 0.004% in Subjects With Glaucoma or Ocular Hypertension	Completed	Alcon Research	Phase 4	2003-04-01	The primary objective of this study is to describe the effect of TRAVATAN 0.004% Ophthalmic Solution on aqueous humor dynamics in subjects with a clinical diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
NCT00121147 ↗	Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan	Completed	Alcon Research	N/A	2003-09-01	The purpose of this study is to compare the additive effect on eye pressure of Azopt and Alphagan P to Travatan.
NCT00121147 ↗	Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan	Completed	Hermann Eye Center	N/A	2003-09-01	The purpose of this study is to compare the additive effect on eye pressure of Azopt and Alphagan P to Travatan.
NCT00308945 ↗	Influence of Prostaglandins on Ocular Blood Flow in Glaucoma Patients	Completed	University Hospital, Basel, Switzerland	Phase 4	2003-11-01	Vasoactivity of topical drugs may be of prognostic relevance in glaucoma. There is very little information for a major class, the prostaglandin analogues with regard to this aspect. The purpose of this study is to compare the effect of travoprost 0.004% and latanoprost 0.005% on choroidal blood flow and retinal vascular diameter in glaucoma patients. After washout of current topical medication, intraocular pressure (IOP) in both eyes (Goldmann applanation tonometry), choroidal blood flow (laser Doppler flowmetry) and retinal vessel diameter (Retinal Vessel Analyzer) in one randomly selected eye will be measured at baseline, after two weeks and after 4 weeks of treatment with travoprost or latanoprost QD, in a randomized, double masked 2-way cross-over study in 20 open angle glaucoma patients.
NCT00331240 ↗	24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination	Completed	Aristotle University Of Thessaloniki	Phase 3	2006-03-01	The purpose of this study is to compare the short-term (8 week) mean 24-hour intraocular pressure control and safety of TravTim fixed combination given once in the evening with placebo once in the morning versus TravTim given once in the morning with placebo once in the evening in patients with open-angle glaucoma.

Clinical Trial Conditions for travoprost

Condition Name

Condition Name for travoprost
Intervention	Trials
Ocular Hypertension	64
Glaucoma	41
Open-Angle Glaucoma	23
Open Angle Glaucoma	13

Condition MeSH

Condition MeSH for travoprost
Intervention	Trials
Glaucoma	90
Ocular Hypertension	73
Glaucoma, Open-Angle	60
Hypertension	53

Clinical Trial Locations for travoprost

Trials by Country

Trials by Country for travoprost
Location	Trials
United States	127
Canada	6
Armenia	5
Germany	3
Italy	3

Trials by US State

Trials by US State for travoprost
Location	Trials
Texas	20
California	11
Georgia	7
Ohio	6
Oklahoma	6

Clinical Trial Progress for travoprost

Clinical Trial Phase

Clinical Trial Phase for travoprost
Clinical Trial Phase	Trials
PHASE2	2
Phase 4	56
Phase 3	21

Clinical Trial Status

Clinical Trial Status for travoprost
Clinical Trial Phase	Trials
Completed	79
Terminated	7
Recruiting	6

Clinical Trial Sponsors for travoprost

Sponsor Name

Sponsor Name for travoprost
Sponsor	Trials
Alcon Research	57
Glaukos Corporation	12
Allergan	6

Sponsor Type

Sponsor Type for travoprost
Sponsor	Trials
Industry	90
Other	25
U.S. Fed	1

Last updated: July 22, 2026

Travoprost clinical trials update, market analysis, and exclusivity timeline

Travoprost is an established ophthalmic prostaglandin analog used to lower intraocular pressure (IOP) in glaucoma and ocular hypertension. It is commercially mature, with patent and regulatory exclusivity largely expired in most jurisdictions. Market growth is driven by volume expansion in glaucoma care, geographic penetration in emerging markets, and periodic product lifecycle upgrades (fixed combinations, preservative changes, and delivery-system improvements). Competitive pressure centers on latanoprost, bimatoprost, tafluprost, and multiple generics, with branded differentiation mostly tied to formulation, dosing convenience, and safety/tolerability profiles.

What is travoprost used for and how is it positioned in glaucoma treatment?

Travoprost lowers IOP by increasing uveoscleral outflow. The standard clinical niche is:

• Primary open-angle glaucoma (POAG)
• Ocular hypertension
• Often considered in treatment algorithms where tolerability, adherence, and cost matter

Current clinical role in practice

• First-line prostaglandin-class therapy in many settings
• Switched-to option when other prostaglandin analogs are inadequate or not tolerated
• Used as monotherapy or combined with other IOP-lowering agents (typically via fixed-combination products in the market)

Key clinical endpoints that trials historically target

• Mean diurnal IOP reduction at defined timepoints
• Proportion achieving IOP targets
• Safety: conjunctival hyperemia, ocular irritation, corneal effects, eyelash changes, iris pigmentation risk (class effect)

What comparators dominate travoprost clinical evidence?

Most comparative trials and pragmatic studies use other prostaglandin analogs and fixed-combination backbones:

• Latanoprost
• Bimatoprost
• Tafluprost
• Timolol or brimonidine combinations (by study design)

What is the latest travoprost clinical trials update (interventional vs real-world)?

A comprehensive “latest” update requires a current clinical trials registry pull (ClinicalTrials.gov, EU CTR, ICTRP). No such registry data is present in the input available here, so a complete, accurate update cannot be produced.

Are there ongoing travoprost late-stage trials and what designs are being used?

A complete and accurate late-stage status assessment also requires live registry and publication feeds. Without verifiable trial records, only a non-actionable general statement is possible, which is not provided.

What patents protect travoprost and when do they expire?

Travoprost’s core chemical and early composition-of-matter protection is long past. In practice, the enforceable IP landscape for travoprost in the US and major markets is dominated by:

• Reformulation patents (preservative systems, buffers, pH, osmolarity)
• Fixed-combination patents (when travoprost is paired with timolol, brimonidine, etc.)
• Device-adjacent and manufacturing process patents (less common but persistent)
• Brand-specific method-of-use and dosing convenience patents (where applicable)

Actionable IP reality for market entry

• For established actives with broad generic availability, generic entry risks are usually formulation- and route-specific, not molecule-wide.
• The decisive question for any generic is whether the applicant targets a listed formulation with a still-active patent or exclusivity barrier in each jurisdiction.

Which patent estate categories matter for travoprost generics vs brands?

• Formulation: excipient, preservative concentration, pH and stability-driven design-arounds
• Combination: whether the product is monocomponent or paired in a fixed-dose system
• Manufacturing: validated scale-up and impurity profile constraints

What is the Orange Book status of travoprost in the US?

A correct Orange Book status requires the FDA publication list for travoprost products and their listed patents/exclusivities by applicant. No Orange Book extract is included in the input available here, so a complete status cannot be produced.

When does travoprost lose exclusivity and what breaks first: patents or exclusivities?

Travoprost is a mature molecule. In standard lifecycle patterns, first-molecule exclusivity expires early, while product-specific exclusivities (if any) and later formulation patents can extend barriers for specific SKUs. A timeline with specific dates requires verified patent-by-patent mapping to each marketed NDA/ANDA strength and dosage form, which is not available here.

What generic entry risks exist for travoprost products (Paragraph IV / litigation)?

Paragraph IV challenges depend on specific ANDA filings and Orange Book listings for particular product strengths and formulations. Without the product-level Orange Book dataset and the associated ANDA litigation docket, a complete and accurate risk assessment cannot be produced.

How many formulations are competing with travoprost and what are the key delivery formats?

Travoprost competes primarily as:

• Ophthalmic solutions (single-agent)
• Fixed-combination ophthalmic drops (depending on geography and brand strategy)

Main market differentiation levers

• Preservative system (tolerability and dry eye risk)
• Dosing schedule (usually once-daily in the class)
• Conjunctival hyperemia mitigation, where supported by formulation

How does travoprost compare with latanoprost, bimatoprost, and tafluprost on efficacy and tolerability?

Across prostaglandin analogs, IOP lowering is broadly comparable, with differences emerging in tolerability and patient preference.

Typical differentiation points

• Conjunctival hyperemia rates vary by formulation and patient population
• Ocular surface comfort and dryness can be formulation dependent (especially preservative-related effects)
• Adherence outcomes are influenced by dosing convenience and tolerability over time

What market analysis supports a travoprost revenue and demand projection?

Global demand drivers

• Rising glaucoma prevalence with aging demographics
• Long-term chronic use creating sustained volume
• Migration toward combination therapy in later lines of treatment
• Increased access and procurement in emerging markets

Key headwinds

• Generic substitution in most markets
• Price erosion typical for established ophthalmic actives
• Formulation safety scrutiny (preservatives, ocular surface disease)
• Competitive intensity from newer prostaglandin analogs and combination products

Projection approach for business planning (what matters)

For a defensible projection, the model typically breaks demand into:

• Diagnosed and treated glaucoma pool growth
• Persistence and switching rates within prostaglandin class
• Share shifts among prostaglandins and fixed combinations
• Pricing: brand premium vs generics, and tender dynamics

A numeric forecast requires market sizing baselines (units, ASP, country splits, and patent/entry events) that are not provided in the input available here, so no quantified projection is produced.

Which companies market travoprost and how does the competitive landscape look?

A complete and accurate company-by-company market share and product roster requires a current SKU and tender database or a recent market report dataset. No such dataset is available here.

What patent litigation affects travoprost brands or generic challengers?

Specific litigation and settlement terms require:

• Filed cases tied to particular ANDAs or NDAs
• Docket outcomes and any consent judgments

No litigation dataset is present here, so a complete litigation map cannot be produced.

How strong is the patent estate for travoprost compared with other glaucoma drops?

In mature small-molecule ophthalmics, the patent estate strength usually shifts from molecule-wide claims to:

• Product-formulation defensibility
• Fixed-combination-specific claims
• Manufacturing process niches

A robust comparison needs patent-by-patent counts and expiration dates across jurisdictions, which are not provided here.

What formulations are most likely to be protected for travoprost going forward?

Going forward, likely defensible areas include:

• Preservative system and ocular surface compatibility improvements
• Stability and shelf-life driven reformulations
• Fixed-combination regimens where a later patent family exists

Accurate identification of specific protected formulations requires patent family retrieval and mapping to marketed SKUs, which is not included.

Key Takeaways

• Travoprost is mature and primarily differentiated in today’s market by formulation and tolerability rather than by molecule-level exclusivity.
• Competitive pressure is dominated by other prostaglandin analogs and generic substitution.
• A true clinical trials “latest update,” an Orange Book status view, and an exclusivity/patent timeline require product-level registry and FDA patent listing data that is not present in the input available here.

FAQs

1. What dosing schedule is used for travoprost and how does it influence adherence?
2. Which ocular safety outcomes are most monitored in prostaglandin analog trials for glaucoma?
3. Do fixed-combination travoprost products face different patent barriers than monotherapy?
4. What factors drive switching between travoprost and other prostaglandin analogs in real-world practice?
5. How do tender and reimbursement dynamics typically affect travoprost pricing after generic entry?

References

No sources were provided in the input available here; no citations can be generated.