Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for Allergic Conjunctivitis

Browse trials for

• Conjunctivitis 361
• Conjunctivitis, Allergic 226

Keywords

• Allergic conjunctivitis
• Red eyes
• Eyelid swelling
• Ragweed
• Allergies
• Itchy eyes
• Ocular redness
• Chemosis
• Tearing
• Watery eyes

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 224 is above the median of 100 across 299 interventional studies indexed under Conjunctivitis.

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Study arms

• Experimental
  AL-53817

  AL-53817 Ophthalmic Solution, 0.1%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)

  Drug: AL-53817 Ophthalmic Solution, 0.1%

• Experimental
  AL-78843

  AL-78843 Ophthalmic Solution, 0.03%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)

  Drug: AL-78843 Ophthalmic Solution, 0.03%

• Active comparator
  Maxidex

  Dexamethasone Ophthalmic Suspension, 0.1%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)

  Drug: Dexamethasone Ophthalmic Suspension, 0.1%

• Placebo comparator
  Vehicle

  AL-53817 Vehicle, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)

  Drug: AL-53817 Vehicle

Interventions

• DrugAL-53817 Ophthalmic Solution, 0.1%
• DrugAL-78843 Ophthalmic Solution, 0.03%
• DrugDexamethasone Ophthalmic Suspension, 0.1%

  Also known as: Maxidex®

• DrugAL-53817 Vehicle

  Inactive ingredients used for masking purposes

Primary outcomes

1. Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7

   Ocular redness ratings were collected for nasal and temporal areas of each eye and assessed by investigational center staff using a visual scale (ie, scored by comparing the subject's eye with a series of photographs) and graded on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)\[Day 7\] - AUC(0-10) \[Baseline\]. Both eyes contributed to the analysis.

   Time frame: 0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7

Secondary outcomes

1. Mean Change From Baseline in Ocular Itching, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7

   Ocular itching was assessed by the subject with both eyes rated together and scored on a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub). AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)\[Day 7\] - AUC(0-10) \[Baseline\].

   Time frame: 0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7

Baseline characteristics

Publications

• Jacobs RL, Ramirez DA, Rather CG, Andrews CP, Jupiter DC, Trujillo F, Shulman DG. Redness response phenotypes of allergic conjunctivitis in an allergen challenge chamber. Ann Allergy Asthma Immunol. 2017 Jan;118(1):86-93.e2. doi: 10.1016/j.anai.2016.10.023. PubMed 28007090 ↗