Treatment of Inflammation and Pain after Cataract Surgery
Conditions
Interventions
Test group:Drip into the conjunctival sac of the study eye
Control group:APP13007 Placebo
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Provided signed and dated informed consent. 2. Age = 18 years at time of informed consent. 3. Males or females of non-childbearing potential. Females of non-childbearing potential were defined as women who have been permanently sterilized or are postmenopausal. Postmenopausal was defined as amenorrhea for a minimum of 12 months (without an alternative medical cause). 4. Women-of-childbearing-potential were eligible for enrollment if they had a negative urine pregnancy test on POD1 prior to Randomization and they agreed to abstain from sexual activity or use a highly effective contraceptive such as occlusive cap (diaphragm or cervical/vault cap) plus spermicidal agent (foam/gel/film/cream/suppository), oral contraceptive, injectable progesterone, implant of etonogestrel or levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, or intrauterine device from POD1 to POD22. 5. Expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye (designated the ‘Study Eye’). 6. Have a pin-hole corrected visual acuity without other correction of = 1.3 logarithm of the minimum angle of resolution (logMAR) in the study eye to be operated and contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Visit 1. 7. Willing and able to comply with study requirements and visit schedule; able to either self-administer study medication or have someone available (e.g., spouse, caregiver, etc.) who could administer study medication according to the study schedule and instructions.
Exclusion criteria
Exclusion criteria: 1. Known sensitivity or allergy to any of the study drug ingredients (including benzalkonium chloride and soy lecithin) or to any conventional drugs required during cataract surgery or to perform the study procedure. 2.Have an ACC count > 0 or any evidence of intraocular inflammation in either eye at the Screening visit. 3.Have a Grade > 0 on the Ocular Pain Assessment in either eye at the Screening visit. 4. Had an immunosuppressive or autoimmune disease that researchers have determined may affect intraocular inflammation or the normal healing process of the eye. 5. Had an active or chronic/recurrent eye or systemic disease that is not controlled and may affect wound healing and/or resolution of inflammation after cataract surgery. 6. Suspected or known malignant tumor or currently receiving antitumor therapy. 7. Subjects who are using certain medications such as Eliac ® (aflibercept), Avastin ® (Bevacizumab), Novactex ® (ranibizumab), Conbercept, or Vetradal ® (verteporfin) for macular degeneration (in either eye). 8. Have an IOP 22 mmHg in either eye or a difference of > 5 mmHg between the eyes at the Screening visit. 9. A documented history of repeated IOP elevation or glaucoma. 10. Study eye has a history of herpetic keratitis. 11. Study eyes with active corneal abrasions or ulcers. 12. Study the history of active chronic or recurrent inflammatory eye diseases (e.g., iritis, scleritis, uveitis, iridocyclitis, iris erythrosis) or such diseases. 13. acute eye infections ; Ocular tuberculosis; Evidence of intraocular infection, active meibomian gland cysts, or uncontrolled severe blepharitis. 14. Study eyes with corneal dystrophy (including titration corneal dystrophy and Fuchs corneal endothelial dystrophy) or thyroid-associated eye disease. 15. Study eyes with uncontrolled and clinically significant dry eyes (mild dry eyes where artificial tears are allowed). 16. The study eye had proliferative diabetic retinopathy (PDR) and significant impairment of macular function; Significant macular disease; There is a history of clinically significant macular edema or cystic macular edema (CME). 17. The tudy eye cup to disc ratio > 0.8. 18. Corneal or retinal surgery (laser or incisional) had been performed in the study eye within 6 months before the screening visit, or laser or incisional surgery (other than cataract surgery) was planned during the study. 19. Plan and arrange contralateral eye surgery within 2 months before or during the study eye surgery. 20. The study eye had previous ocular trauma with significant scarring or any deformity resulting from trauma that was judged by the investigator to be likely to affect the pharmacokinetics of the study drug or the postoperative outcome. 21. Contact lenses or collagen membranes should be used in either eye within 72 hours before cataract surgery or during the rest of the study. 22. A non-diagnostic topical ophthalmic medication is required for either eye during the study period. 23. The investigators determined that the study eye may develop ocular bleeding that may interfere with the evaluation of postoperative inflammation. 24. Study eyes were scheduled to undergo or had undergone femtosecond laser or any other ophthalmic surgery in addition to cataract surgery by phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation. 25. Capsulorrhoea (e.g. Trypan blue) is planned or has been used for anterior capsular staining during cataract surgery. 26. Plan to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with Anterior Chamber Cell (ACC) Count = 0 after Cataract Surgery;The proportion of subjects with Ocular Pain Grade = 0 after Cataract Surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with ACC count = 0 at PODs 4, 8 and 15;Proportion of subjects with Ocular Pain Grade = 0 at PODs 4, 8 and 15;Proportion of subjects with Anterior chamber flare (ACF) Grade = 0 at POD8 maintained through POD15;Proportion of subjects with ACF Grade = 0 at PODs 4, 8 and 15;Mean change-from-baseline in ACC Grade at PODs 4, 8, and 15;Mean change-from-baseline in Ocular Pain Grade at PODs 4, 8 and 15; | — |
Countries
China
Contacts
Public ContactNingli Wang
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed