Treatment of inflammation and pain associated with cataract surgery Eye Diseases Cataract
Conditions
Interventions
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 w
Sponsors
Layerbio, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety as measured by the frequency and severity of treatment-related adverse events assessed from baseline to 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Mexico
Outcome results
None listed