The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

15 Dec 2015 → ongoing

Decision date (initial)

2024-12-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AbbVie Inc.

External identifiers

EU CT number

2024-519595-87-00

EudraCT number

2014-003186-24

ClinicalTrials.gov

NCT02250651

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 2 dose strengths of Bimatoprost SR in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) after initial and repeated administrations

Conditions and MedDRA coding

Ocular hypertension

Regulatory references

Scientific advice from competent authorities

Medicines And Healthcare Products Regulatory Agency, Danish Medicines Agency, Swedish Medical Products Agency

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Diagnosis of either OAG (ie, primary, pseudoexfoliation, or pigmentary glaucoma) or OHT in each eye and both eyes require IOP-lowering treatment (Note: diagnosis does not have to be the same in both eyes)
2. In the investigator’s opinion, either eye can be treated adequately with topical ophthalmic beta-blocker (eg, timolol) eye drops as the sole therapy In the investigator’s opinion, either eye can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog (eg, LUMIGAN, Xalatan, Travatan) eye drops as the sole therapy
3. The iridocorneal angle in the study eye must be independently confirmed as being qualified by 2 ophthalmologists using the following criteria: a. Shaffer Grade ≥ 3 on clinical gonioscopy of the inferior angle b. Peripheral anterior chamber depth by Van Herick examination ≥ 1/2 corneal thickness. Note: The independent eligibility assessments must both agree that the Shaffer grade is ≥ 3 and the Van Herick grade is ≥ 1/2 corneal thickness.
4. At the Baseline visit: Hour 0 IOP in the study eye of ≥ 22 mm Hg and ≤ 32 mm Hg, and in the fellow eye of ≤ 32 mm Hg
5. At the Baseline visit: Hour 2 IOP in the study eye of ≥ 19 mm Hg and ≤ 32 mm Hg, and in the fellow eye of ≤ 32 mm Hg
6. By the Baseline visit, the final central endothelial cell density in both eyes must be confirmed as being qualified by Reading Center assessment, with at least one eye qualified for inclusion as the study eye
7. In the investigator’s opinion, either eye can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog (eg, LUMIGAN, Xalatan, Travatan) eye drops as the sole therapy

Exclusion criteria 3

1. The following surgical history: a. History or evidence of complicated cataract surgery in the study eye: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant [IOL], sulcus IOL, aphakia, etc) or intraoperative complications (such as a posterior capsular tear [with or without vitreous loss], substantial iris trauma, etc) Note: history of uncomplicated cataract surgery is not an exclusion. b. History of phakic IOL insertion for refractive error correction in the study eye
2. In the investigator’s opinion, patient is nonresponsive to topical ophthalmic beta-blockers and/or topical prostamides, prostaglandins, or prostaglandin analogs (eg, LUMIGAN, Xalatan, Travatan)
3. Contraindications to beta-blocker therapy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Study eye time-matched IOP change from baseline (follow-up minus time-matched baseline) at each hour evaluated (Hours 0 and 2).

Secondary endpoints 1

1. Time-matched IOP

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 3

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications