Evidence map›Paper›PMID 38985408›Full record

ArticleOphthalmology and therapy2024

Travoprost Intracameral Implant Demonstrates Superior IOP Lowering Versus Topical Prostaglandin Analog Monotherapy in Patients with Open-Angle Glaucoma or Ocular Hypertension.

Jason Bacharach, Long V Doan, Kerry G Stephens, Dale W Usner, Angela C Kothe, L Jay Katz, Tomas Navratil

2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Ophthalmology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03519386 phase3completednot on this map

Prospective, Randomized Phase III Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%

TypeinterventionalSponsorGlaukos CorporationRan2018 to 2024Enrolled590ConditionsGlaucoma, Open-Angle, Ocular HypertensionArmsG2-TR intraocular implant containing travoprost, Sham surgery + active-comparator eye drops
NCT03868124 phase3completednot on this map

Prospective, Randomized Phase III Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%

TypeinterventionalSponsorGlaukos CorporationRan2018 to 2024Enrolled560ConditionsGlaucoma, Open-Angle, Ocular HypertensionArmsG2-TR intraocular implant containing travoprost, Sham surgery + active-comparator eye drops
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Jason BacharachNorth Bay Eye Associates, Inc., 104 Lynch Creek Way, Suite 15, Petaluma, CA, 94954, USA.ORCID http://orcid.org/0000-0002-7084-4327
Long V DoanGlaukos Corporation, One Glaukos Way, Aliso Viejo, CA, 92656, USA.ORCID http://orcid.org/0009-0008-0572-2236
Kerry G StephensGlaukos Corporation, One Glaukos Way, Aliso Viejo, CA, 92656, USA.
Dale W UsnerGlaukos Corporation, One Glaukos Way, Aliso Viejo, CA, 92656, USA.ORCID http://orcid.org/0000-0002-2799-0652
Angela C KotheGlaukos Corporation, One Glaukos Way, Aliso Viejo, CA, 92656, USA.ORCID http://orcid.org/0009-0000-7971-5292
L Jay KatzGlaukos Corporation, One Glaukos Way, Aliso Viejo, CA, 92656, USA.
Tomas NavratilGlaukos Corporation, One Glaukos Way, Aliso Viejo, CA, 92656, USA. tnavratil@glaukos.com.ORCID http://orcid.org/0009-0007-3577-3096

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis study was conducted to analyze and compare the intraocular pressure (IOP) treatment effect of the slow-eluting (SE) travoprost intracameral implant to the IOP treatment effect of topical prostaglandin analog (PGA) monotherapy in a subgroup of subjects who were on pre-study PGA monotherapy prior to enrollment in the two pivotal phase 3 trials of the travoprost intracameral implant.

methodsA combined study population of 133 subjects from two phase 3 trials, who were on topical PGA monotherapy at screening, subsequently underwent a washout period from their topical PGA, and then were randomized and administered an SE travoprost intracameral implant. The subjects were analyzed for the IOP treatment effects of the pre-study topical PGA monotherapy and the in-study SE travoprost intracameral implant. Paired t-tests were used to compare the difference in screening minus post-washout baseline IOP versus month 3 minus post-washout baseline IOP. The IOP-lowering efficacy in eyes administered an SE travoprost intracameral implant was compared to the IOP lowering in the same eyes while on a topical PGA monotherapy prior to study entry.

resultsPre-study topical PGA monotherapy and the SE travoprost intracameral implant demonstrated IOP treatment effects of -5.76 mmHg and -7.07 mmHg, respectively. The IOP-lowering treatment effect was significantly greater by 1.31 mmHg for the SE travoprost intracameral implant relative to pre-study PGA monotherapy (95% confidence interval: -2.01, -0.60; P = 0.0003).

conclusionsThe SE travoprost intracameral implant demonstrated superior IOP-lowering treatment effect versus pre-study topical PGA monotherapy with a superiority margin that was both statistically significant and clinically meaningful. The greater IOP reduction from baseline while on the SE implant versus pre-study topical PGA monotherapy may be a reflection of the optimized adherence and continuous elution of PGA therapy into the anterior chamber achieved with the SE travoprost intracameral implant.

trial registrationClinicalTrials.gov identifiers, NCT03519386 and NCT03868124.

Indexed as

AdherenceDrug delivery systemiDose® TRIntraocular pressureProstaglandin analogTravoprost intracameral implant

Identifiers

PMID38985408
PMCPMC11341799

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.