Condition category
Eye Diseases
Date applied
22/12/2020
Date assigned
23/12/2020
Last edited
23/12/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
OcuRing-K™ is a long-acting implant that contains ketorolac, an anti-inflammatory medication used in eye drops to prevent inflammation and pain after cataract surgery. Eye drops are known to have side effects and can be burdensome for patients to self-administer. A pilot study is being conducted to assess the safety and potential treatment benefit of OcuRing-K™ as an alternative to eye drops for patients undergoing cataract surgery.

Who can participate?
Adults between the ages of 18 to 85 planning to undergo cataract surgery may be eligible to participate in this study.

What does the study involve?
Participation in study is no different from undergoing ordinary cataract surgery. The surgical procedure will be performed according to the standard of care, and the timing and duration of follow-up examinations will be the same as for ordinary cataract surgery.

What are the possible benefits and risks of participating?
Benefits to participating include not needing to take an anti-inflammatory eye drop after cataract surgery and contributing to the scientific research for the greater good of society. Risks associated with participation in the study include exposure to a new drug inside the eye, which may include inflammation, infection and elevation of eye pressure. These risks are not significantly different from the usual risks associated cataract surgery.

Where is the study run from?
Asociación para Evitar la Ceguera en México (Mexico)

When is the study starting and how long is it expected to run for?
From October 2019 to February 2020

Who is funding the study?
LayerBio, Inc (USA)

Who is the main contact?
Dr. Roberto Gonzalez-Salinas
dr.gonzalezsalinas@apec.com.mx

Trial website

Contact information

Type

Scientific

Primary contact

Dr Roberto Gonzalez-Salinas

ORCID ID

http://orcid.org/0000-0001-6654-5191

Contact details

Asociación para Evitar la Ceguera en México
Vicente García Torres 46
San Lucas Coyoacán
Mexico City
04030
Mexico
+52 55 1084 1400
dr.gonzalezsalinas@apec.com.mx

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

OCUR-1

Study information

Scientific title

Pilot study to assess safety and efficacy of OcuRing-K™ ketorolac implant for cataract surgery

Acronym

Study hypothesis

OcuRing-K™ is safe and well tolerated by subjects undergoing cataract surgery.

Ethics approval

Approved 02/12/2019, Comité de Ética en lnvestigación, (Asociación para Evitar la Ceguera en México, Vicente García Torres 46, San Lucas Coyoacán, PO. 04030. Mexico City, Mexico; no telephone contact available; no email contact available)

Study design

Single-site interventional single-arm open-label non-randomized trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Treatment of inflammation and pain associated with cataract surgery

Intervention

Participants in this study will undergo cataract surgery according to the standard of care. A single dose of the study drug will be administered into the eye at the time of surgery. Follow up visits will occur at 1, 7 and 28 days after cataract surgery. The content and duration of each postoperative visit is the same as the standard of care. No additional time is required for participation in this study.

Intervention type

Drug

Phase

Phase I

Drug names

phenylephrine, ketorolac, OcuRing-K™ ketorolac ophthalmic implant

Primary outcome measure

1. Safety as measured by the frequency and severity of treatment-related adverse events assessed from baseline to 28 days

Secondary outcome measures

1. Pain measured by visual analog scale (VAS) at baseline, 1, 7, and 28 days
2. Ocular inflammation measured by anterior chamber cell (ACC) at baseline, 1, 7, and 28 days

Overall trial start date

21/10/2019

Overall trial end date

06/02/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Undergoing unilateral cataract extraction and implantation of a monofocal
intraocular lens implantation (IOL)
2. Aged ≥18 and ≤ 85 years
3. Willing and able to comply with the protocol requirements, has gone through the consent process, and has signed an approved informed consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

5

Participant exclusion criteria

1. Severe/serious corneal pathology which may preclude study completion.
2. Any extraocular/intraocular inflammation in the study eye at screening visit (blepharitis allowed if mild only, and no concurrent conjunctivitis or lid erythema/edema) or ongoing, unresolved uveitis
3. Ocular surgery of any kind in the study eye within 6 months prior to baseline visit
4. Scheduled for surgery in the fellow eye within the study period
5. Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study
6. Anterior chamber inflammation as measured by slit lamp examination at baseline
7. Use of any topical ocular medication in either eye, other than tear substitute for dry eye, at least 2 weeks prior to the baseline visit
8. Currently or within the past 5 years, have a history of malignancy other than successfully treated squamous or basal cell carcinoma of the skin or successfully treated in situ cervical cancer
9. Oral corticosteroid within the past 14 days prior to Visit 1 or topical corticosteroid ≤ 48 h prior to Visit 1
10. Prescribed nonsteroidal anti-inflammatory drugs (NSAIDs) or immunosuppressive agents, unless the dose has been stable for the last six weeks and no change in dosing is anticipated for the duration of the study
11. Intravitreal or sub-Tenon corticosteroid treatment in the study eye within the past 6 months prior to Visit 1
12. Intracocular pressure (IOP) ≥ 25 mmHg at baseline, a history of glaucoma, or require ocular antihypertensive medications in the study eye
13. Known steroid intraocular pressure responders in either eye
14. Have participated in another investigational device or drug study within 3 months prior to Visit 1

Recruitment start date

03/12/2019

Recruitment end date

07/01/2020

Locations

Countries of recruitment

Mexico

Trial participating centre

Asociación para Evitar la Ceguera en México
Vicente García Torres 46 San Lucas Coyoacán
Mexico City
04030
Mexico

Sponsor information

Organisation

Layerbio, Inc.

Sponsor details

60 Cary Ave
Lexington
02421
United States of America
+1 ‭(617) 453-8210‬
ken@layerbio.com

Sponsor type

Industry

Website

https://www.layerbio.com

Funders

Funder type

Industry

Funder name

LayerBio, Inc.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
Participant-level data will be included in the peer-reviewed publication.

Intention to publish date

01/06/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/12/2020: Trial’s existence confirmed by Asociación para Evitar la Ceguera en México.