Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain

Phase 3

Completed

Conditions: Post Surgical Ocular Inflammation and Pain

Interventions: Drug: KPI-121 1% Ophthalmic Suspension dosed BID
Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID

Registration Number: NCT02793817

Lead Sponsor: Kala Pharmaceuticals, Inc.

Brief Summary: The primary objective of the study is to investigate the efficacy and safety of KPI-121 1.0% ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.

Detailed Description: This is a Phase III, multicenter, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of KPI-121 1.0% ophthalmic suspension versus placebo in subjects who require treatment of postoperative anterior ocular inflammation.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 520

Inclusion Criteria

Candidates for routine, uncomplicated cataract surgery

In Investigator's opinion, potential postoperative Snellen Distance VA by pinhole method of at least 20/200 in study eye.

Exclusion Criteria

Known hypersensitivity/contraindication to study product(s) or components.
History of glaucoma, intraocular pressure (IOP) >21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye.
Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening or 18 days following surgery.
In the opinion of Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KPI-121 1.0% Ophthalmic Suspension	KPI-121 1% Ophthalmic Suspension dosed BID	dosed BID
Vehicle of KPI-121 Ophthalmic Suspension	Vehicle of KPI-121 Ophthalmic Suspension dosed BID	dosed BID

Primary Outcome Measures

Name	Time	Method
Complete Resolution of Anterior Chamber (AC) Cells at Day 8	Visit 5 (Day 8) maintained through Visit 6 (Day 15)	Number and percentage of subjects with complete resolution of AC cells in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better. Anterior Chamber Cells 0 = No cells seen 1. = 1 - 5 cells 2. = 6 - 15 cells 3. = 16 - 30 cells 4. = greater than 30 cells
Complete Resolution of Ocular Pain at Day 8	Visit 5 (Day 8) maintained through Visit 6 (Day 15)	Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. Higher scores were worse outcomes. The following scoring scale was used for ocular pain: 0 = None 1. = Minimal 2. = Mild 3. = Moderate 4. = Moderately Severe 5. = Severe

Secondary Outcome Measures

Name	Time	Method
Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4	Visit 1 (Baseline) and Visit 4 (Day 4)	The difference in mean changes from BL in AC cell count grade at Day 4 for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better. Anterior Chamber Cells 0 = No cells seen 1. = 1 - 5 cells 2. = 6 - 15 cells 3. = 16 - 30 cells 4. = greater than 30 cells
Complete Resolution of Anterior Chamber (AC) Flare at Day 4	Visit 4 (Day 4) maintained through Visit 6 (Day 15)	Number and percentage of subjects with complete resolution of AC flare in the surgical eye (study eye) at Day 4 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Investigators were asked to grade AC flare based on the following scale wherein higher scores indicate a higher degree of flare present and a decrease across time indicates the condition is getting better. Anterior Chamber Flare 0 = None 1. = Mild (trace to clearly noticeable, visible) 2. = Moderate (without plastic aqueous humor) 3. = Marked (with plastic aqueous humor) 4. = Severe (with fibrin deposits and/or clots)
Complete Resolution of Ocular Pain at Day 4	Visit 4 (Day 4) maintained through Visit 6 (Day 15)	Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 4 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID. Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. Higher scores were worse outcomes. The following scoring scale was used for ocular pain: 0 = None 1. = Minimal 2. = Mild 3. = Moderate 4. = Moderately Severe 5. = Severe

Trial Locations

Locations (35): Arizona Eye Center
🇺🇸
Chandler, Arizona, United States
Cornea and Cataract Consultants of CA
🇺🇸
Phoenix, Arizona, United States
Sall Research Medical Center
🇺🇸
Artesia, California, United States
Orange County Ophthalmology
🇺🇸
Garden Grove, California, United States
Lugene Eye Institute
🇺🇸
Glendale, California, United States
Inland Eye Specialists
🇺🇸
Hemet, California, United States
United Medical Research Institute
🇺🇸
Inglewood, California, United States
LoBue Laser and Eye Medical Center
🇺🇸
Murrieta, California, United States
Pendleton Eye Center
🇺🇸
Oceanside, California, United States
North Bay Eye Associates, Inc.
🇺🇸
Petaluma, California, United States
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Arizona Eye Center
🇺🇸Chandler, Arizona, United States