Last Updated: May 1, 2026

CLINICAL TRIALS PROFILE FOR TRAVOPROST


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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NCT01452009 ↗ Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004% Withdrawn Alcon Research Phase 3 2011-11-01 A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

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

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

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

Sponsor Name

Sponsor Name for travoprost
Sponsor Trials
Alcon Research 57
Glaukos Corporation 12
Ocular Therapeutix, Inc. 6
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Sponsor Type

Sponsor Type for travoprost
Sponsor Trials
Industry 90
Other 25
U.S. Fed 1
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Travoprost Clinical Trials Update, Market Analysis, and Projection

Last updated: April 23, 2026

Travoprost is a prostaglandin analog used primarily for glaucoma and ocular hypertension, with commercial maturity across multiple geographies. Current activity is dominated by (1) formulation and delivery improvements, (2) combination products, (3) pediatric and real-world evidence work, and (4) bioequivalence and post-approval studies. Patent life and competitive pressure are driven by local generic entry and fixed-combination launches rather than new molecular IP.

What is the current clinical-trial landscape for travoprost?

Clinical activity for travoprost is largely incremental rather than novel-mechanism development. Trial themes concentrate on:

  • Safety and tolerability of travoprost-containing regimens in routine ophthalmic care
  • Bioequivalence and pharmacokinetic readouts for reformulated products
  • Efficacy confirmation on intraocular pressure (IOP) endpoints
  • Real-world or comparative effectiveness studies versus other prostaglandin analogs

Trial patterns seen in the landscape

Across registries, travoprost studies tend to use established outcome measures:

  • IOP reduction from baseline at defined post-dose time points
  • Ocular surface tolerability (conjunctival hyperemia, irritation)
  • Adherence and persistence (where real-world designs are used)
  • Switch studies (travoprost-to-other prostaglandin analog or vice versa)

What endpoints dominate?

In trials that report efficacy, the most repeated endpoint is:

  • Mean IOP change from baseline for the study eye(s), typically at multiple time points

Typical safety endpoints include:

  • Ocular adverse events (hyperemia, burning, itching, dry eye symptoms)
  • Visual acuity and exam-based tolerability

How does the competitive market structure look today?

The travoprost market behaves like a late-stage branded asset with:

  • Large generic penetration
  • Price compression
  • Segment fragmentation by country, formulary, and formulation type
  • Growth pockets where delivery innovations or fixed combinations improve dosing convenience or tolerability

Key competitive cohorts

  1. Generic travoprost monotherapy
  2. Branded prodrug/prostaglandin analog competitors (same class; head-to-head and formulary substitution)
  3. Fixed combinations (class-pairing to improve IOP control and reduce drop burden)

Pricing and access dynamics

Market access is shaped by:

  • Tendering and national formulary controls for ophthalmic drops
  • Switching pressure from payers to lowest-cost bioequivalent alternatives
  • Uptake of fixed combinations when they reduce dosing frequency or improve tolerability profiles

Who are the main downstream stakeholders?

Downstream include:

  • Eye-care providers (switch decisions based on patient response and tolerability)
  • National health systems and payers (tender-driven procurement and step edits)
  • Pharmacy channels handling generic and combination products
  • Combination-product developers competing for add-on therapy share

What does the market projection imply for travoprost?

A mature prostaglandin analog market usually shows:

  • Flat-to-low volume growth driven by population aging and glaucoma prevalence trends
  • Revenue headwinds from ongoing generic entry and tender-based price reductions
  • Net revenue growth only where mix shifts to higher-value formulations (preservative changes, combination products) or where country-specific procurement delays slow generic erosion

Projection logic (structure of growth)

Travoprost market performance typically splits into:

  • Volume: supported by rising glaucoma diagnosis and chronic treatment adherence
  • Value: constrained by generic pricing and competitive substitution
  • Mix: improved by combination adoption and product differentiation within local markets

How will clinical evidence translate into commercial outcomes?

For a mature asset, clinical evidence supports:

  • Regulatory approval of reformulated products
  • Bioequivalence and substitution across geographies
  • Formulary decisions by demonstrating tolerability and stable IOP control

Evidence types that move commercial outcomes fastest:

  • Bioequivalence trials supporting rapid market entry
  • Comparative tolerability and persistence evidence used in payer and clinician preferences
  • Real-world effectiveness studies, especially those showing fewer discontinuations or better adherence

Clinical Trials Update (Structured View)

What kinds of studies still appear for travoprost?

The majority of ongoing and recently completed work clusters into four categories:

Study type Primary purpose Typical endpoints
Bioequivalence Support generic or reformulated product approval Cmax, Tmax, AUC (ocular/systemic where applicable), IOP as supportive
Formulation/delivery Reduce irritation, preserve ocular surface, improve stability IOP reduction, ocular surface tolerability scores
Comparative/real-world Benchmark outcomes versus class rivals or within class IOP control, persistence, switch rates
Special populations Confirm safety in pediatrics or patients with comorbidities Ocular AEs, tolerability, IOP response

What is the practical readout for investors?

Investors should treat new trial updates as:

  • Regulatory and substitution enablers (bioequivalence, tolerability)
  • Mix shift support (combination uptake, delivery improvements)
  • Not a de-risking catalyst for a brand-new mechanism

Market Analysis and Projection

What are the main drivers of demand for travoprost?

  • Glaucoma prevalence growth through aging populations
  • Chronic therapy durability for patients requiring long-term IOP control
  • Physician preference for prostaglandin analogs as first-line drops in many protocols

What are the main headwinds?

  • Generic substitution and tender pricing
  • Class competition (same MOA prostaglandins, plus other IOP-lowering classes)
  • Switching based on side effects (ocular irritation/hyperemia) and patient-specific tolerability

Where can growth still come from?

Growth usually comes from mix, not from innovation:

  • Fixed-combination products using travoprost or class components to reduce dosing burden
  • Local market delays to generic erosion due to procurement cycles and patent/registration timing (country specific)
  • Differentiation by tolerability and preservative systems when adopted by clinicians

Value-growth levers vs volume-growth levers

Lever Impacts Likely direction
Generic substitution Revenue per unit Down
Aging and glaucoma incidence Patient numbers Up
Combination adoption Higher price per treated patient (in many markets) Up
Formulary controls and tenders Contract pricing Down
Reformulation tolerability advantage Persistence and switching Up

Key Takeaways

  • Travoprost’s clinical pipeline is dominated by incremental studies that support reformulation, bioequivalence, tolerability, and real-world outcomes, not new mechanism breakthroughs.
  • Commercial performance is driven by generic penetration, tender pricing, and mix shifts toward combinations rather than brand-level innovation.
  • Market projections should be modeled with stable-to-slightly growing treated volume offset by ongoing value compression, with upside from combination and product differentiation in specific geographies.

FAQs

1) What is travoprost’s primary clinical use?

It is used to lower intraocular pressure in glaucoma and ocular hypertension by targeting the prostaglandin pathway.

2) Why do most travoprost trial updates look similar over time?

Because the molecule is mature; new work typically focuses on reformulation, bioequivalence, and comparative outcomes using standard IOP and ocular tolerability endpoints.

3) What is the main commercial risk for travoprost?

Sustained generic substitution and procurement-driven price reductions.

4) What is the most meaningful growth lever?

Mix shift toward higher-value formulations, especially fixed combinations that reduce drop burden and can improve persistence.

5) How should investors interpret “active trials” for travoprost?

As regulatory and substitution support rather than as evidence of a new therapeutic class expansion.


References

[1] ClinicalTrials.gov. “Travoprost” results and study record listings. https://clinicaltrials.gov/

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