A clinical trial to assess the preliminary safety and treatment benefit of a long-acting anti-inflammatory medication for cataract surgery
| ISRCTN | ISRCTN10336649 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10336649 |
| Secondary identifying numbers | OCUR-1 |
- Submission date
- 22/12/2020
- Registration date
- 23/12/2020
- Last edited
- 14/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
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
Contact information
Scientific
Asociación para Evitar la Ceguera en México
Vicente García Torres 46
San Lucas Coyoacán
Mexico City
04030
Mexico
 ORCID ID |
0000-0001-6654-5191 |
|---|---|
| Phone | +52 55 1084 1400 |
| dr.gonzalezsalinas@apec.com.mx |
Study information
| Study design | Single-site interventional single-arm open-label non-randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Pilot study to assess safety and efficacy of OcuRing-K™ ketorolac implant for cataract surgery |
| Study objectives | OcuRing-K™ is safe and well tolerated by subjects undergoing cataract surgery. |
| Ethics approval(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | 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 study start date | 21/10/2019 |
| Completion date | 06/02/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 5 |
| Total final enrolment | 5 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/12/2019 |
| Date of final enrolment | 07/01/2020 |
Locations
Countries of recruitment
- Mexico
Study participating centre
San Lucas Coyoacán
Mexico City
04030
Mexico
Sponsor information
Industry
60 Cary Ave
Lexington
02421
United States of America
| Phone | +1 (617) 453-8210 |
|---|---|
| ken@layerbio.com | |
| Website | https://www.layerbio.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | Participant-level data will be included in the peer-reviewed publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | Presented at ARVO | 01/06/2021 | 14/01/2022 | No | No |
Editorial Notes
14/01/2022: The following changes have been made:
1. Abstract reference added.
2. The final enrolment number has been added from the reference.
23/12/2020: Trial’s existence confirmed by Asociación para Evitar la Ceguera en México.
