A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery

Formosa Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Ocular Inflammation and Pain After Cataract Surgery

Treatments: Drug: APP13007, 0.05%; Drug: APP13007 Placebo, 0.1%; Drug: APP13007 Placebo, 0.05%; Drug: APP13007, 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04089735

CPN-201

Details and patient eligibility

About

This is a Phase 2a, 2-part study (designated Parts A and B) that will evaluate APP13007 dose strength and dosing frequency in a randomized double-masked fashion for comparison to the respective matching vehicle placebo. Part A will be conducted first to evaluate 0.05% APP13007 and matching vehicle placebo in an approximate 1:1 ratio in approximately 42 subjects who experience postoperative inflammation on the first day following routine, uncomplicated, cataract surgery and who meet all eligibility criteria. Based on the results of Part A, Part B of the study may be open for enrollment to evaluate 0.05% and/or 0.1% APP13007 at various dosing frequency in approximately 84 subjects, also in an approximate 1:1 ratio, active vs. placebo. In each Part, subjects will return periodically for study assessments during the treatment period and then for a follow-up visit approximately 1 week after stopping the study drug.

Enrollment: 165 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.
• In Investigator's opinion, have Early Treatment Diabetic Retinopathy Study estimated potential of 0.7 (20/100) or better in study eye.
• Have > 10 and ≤ 30 cells in anterior chamber.
• Have an intraocular pressure ≤ 30 mmHg.

Exclusion criteria

• Have an anterior chamber cell count > 0 or any evidence of intraocular inflammation.
• Have a score > 0 on Ocular Pain Assessment in either eye.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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165 participants in 6 patient groups

APP13007 0.05% twice daily (BID) [Part A]

Experimental group

Description:

1 drop 0.05% APP13007 twice daily for 21 days to the operated eye

Treatment:

Drug: APP13007, 0.05%

APP13007 0.05% Placebo twice daily (BID) [Part A]

Experimental group

Description:

1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye

Treatment:

Drug: APP13007 Placebo, 0.05%

APP13007 0.05% twice daily (BID) and once daily (QD) [Part B]

Experimental group

Description:

1 drop 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye

Treatment:

Drug: APP13007, 0.05%

APP13007 0.05% Placebo twice daily (BID) and once daily (QD) [Part B]

Experimental group

Description:

1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye

Treatment:

Drug: APP13007 Placebo, 0.05%

APP13007 0.1% twice daily (BID) and once daily (QD) [Part B]

Experimental group

Description:

1 drop 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye

Treatment:

Drug: APP13007, 0.1%

APP13007 0.1% Placebo twice daily (BID) and once daily (QD) [Part B]

Experimental group

Description:

1 drop matching vehicle placebo for 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye

Treatment:

Drug: APP13007 Placebo, 0.1%