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

Browse trials for

• Cataract 1,696
• Capsule Opacification 98
• Inflammation 3,430

Study arms

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

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

  Drug: APP13007, 0.05%

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

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

  Drug: APP13007 Placebo, 0.05%

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

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

  Drug: APP13007, 0.05%

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

  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

  Drug: APP13007 Placebo, 0.05%

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

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

  Drug: APP13007, 0.1%

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

  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

  Drug: APP13007 Placebo, 0.1%

Interventions

• DrugAPP13007, 0.05%

  APP13007 eye drop, 0.05%

• DrugAPP13007, 0.1%

  APP13007 eye drop, 0.1%

• DrugAPP13007 Placebo, 0.05%

  APP13007 placebo eyedrop, 0.05%

• DrugAPP13007 Placebo, 0.1%

  APP13007 placebo eyedrop, 0.1%

Primary outcomes

1. Number of Treatment Emergent Adverse Events

   Number of treatment emergent adverse events and number of participants.

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

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

   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.

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

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

   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.

   Time frame: Baseline and Post-operative Day 15

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

   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.

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

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

   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).

   Time frame: Baseline and Post-operative Day 15

Secondary outcomes

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

   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.

   Time frame: Post-operative Day 15

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

   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).

   Time frame: Post-operative Day 15

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

   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.

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

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

   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.

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

Baseline characteristics

Study documents

• Study protocol · Nov 15, 2019
• Statistical analysis plan · May 4, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No