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Completed

NCT Number: NCT04089735

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

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.

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Key information

Conditions

Ocular Inflammation and Pain After Cataract Surgery

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cornea and Cataract Consultants of Arizona, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

APP13007, 0.05%

Drug

APP13007 eye drop, 0.05%

APP13007, 0.1%

Drug

APP13007 eye drop, 0.1%

APP13007 Placebo, 0.05%

Drug

APP13007 placebo eyedrop, 0.05%

APP13007 Placebo, 0.1%

Drug

APP13007 placebo eyedrop, 0.1%

Primary outcomes

  1. Number of Treatment Emergent Adverse Events

    Time frame: From First dose to Post-operative Day 28 (Part A) or Day 22 (Part B)

    Number of treatment emergent adverse events and number of participants.

  2. Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye

    Time frame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)

    Intraocular pressure is measured in mm Hg at each study visit with a Goldmann applanation tonometer. The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.

  3. Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye

    Time frame: Baseline and Post-operative Day 15

    The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area.

  4. Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye

    Time frame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)

    The visual acuity in each eye is corrected using the pinhole method and the acuity is quantified on a logMAR (minimal angle of resolution) scale using the 'Early Treatment Diabetic Retinopathy Study' [ETDRS] charts for right and left eyes. A logMAR Score is calculated using the number of incorrect letters.

  5. Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye

    Time frame: Baseline and Post-operative Day 15

    Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).

Secondary outcomes

  1. Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication

    Time frame: Post-operative Day 15

    The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area.

  2. Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication

    Time frame: Post-operative Day 15

    Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).

  3. Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye

    Time frame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)

    The degree of turbidity (flare) in the anterior chamber of the eye is measured using slit-lamp biomicroscopy and quantified on a five-point (0-4) anterior chamber flare grade scale (0 = none; 4 = Intense). The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.

  4. Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment

    Time frame: First dose to Post-operative Day 22 (Part A) or Day 15 (Part B)

    Subjects who do not respond to study treatment after randomization (anterior chamber cell count > 30 cells or an increase in anterior chamber cell count by > 15 cells from pre-dose baseline or ≥ 2 grade of increase in anterior chamber flare from pre-dose baseline) are started on anti-inflammatory medication (referred to as 'Rescue' medication). The number of subjects starting 'Rescue' medication is recorded at each study visit.

Sponsors and collaborators

Lead sponsor

Formosa Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Masked, Two-Part, Placebo-Controlled Phase 2A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 for the Treatment of Inflammation and Pain After Cataract Surgery

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 13, 2019
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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