OCS-01 (Novel Topical Dexamethasone Formulation) in Inflammation and Pain Post Cataract Surgery: A Randomized, Double-Masked, Vehicle-Controlled Study

Clin Ther. 2022 Dec;44(12):1577-1587. doi: 10.1016/j.clinthera.2022.11.003. Epub 2022 Dec 8.


Purpose: The goal of this study was to compare topical dexamethasone 1.5% in a novel formulation (OCS-01) once daily and BID versus vehicle for the treatment of inflammation and pain after cataract surgery.

Methods: This was a Phase II, double-masked, vehicle-controlled, randomized multicenter study. Adult patients with planned unilateral uncomplicated cataract surgery were randomized to receive OCS-01 once daily (n = 51), OCS-01 BID (n = 51), or matching vehicle (n = 51) for 15 days postsurgery. Primary end points were absence of anterior chamber cells (ACC; cells = 0) at Day 15 and absence of pain (score of "0") at postoperative Day 4. The Pearson χ2 test with a two-sided alpha = 0.1 was used to compare treatments. Safety was assessed in terms of adverse events and changes in intraocular pressure.

Findings: Treatment arms were generally similar in their baseline characteristics, with mean age ranging from 66 to 68 years, the proportion of male patients ranging from 29% to 37%, and 82% to 92% of each arm being White. On Day 15, a greater reduction in the percentage of eyes with ACC grade 0 was observed in the OCS-01 once daily (51%) and BID (66.7%) arms than in the vehicle arm (19.6%) (P = 0.0009 and P < 0.0001, respectively, using a Pearson χ2 test). On Day 4, the percentage of eyes with no pain was 72.5% (OCS-01 once daily), 62.7% (OCS-01 BID), and 45.1% (vehicle); statistical significance was reached for OCS-01 once daily (P = 0.005) and OCS-01 BID (P = 0.074) compared with vehicle. OCS-01 was well tolerated. A higher proportion of treatment-emergent adverse events, including ocular adverse events, were reported for the placebo group than for either OCS-01 group.

Implications: OCS-01 once daily and BID were more effective than vehicle and well tolerated in the treatment of inflammation and pain after cataract surgery.

Clinicaltrials: gov identifier: NCT04130802.

Keywords: cataract surgery; dexamethasone ophthalmic suspension; postsurgery inflammation; topical corticosteroids.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Cataract Extraction* / adverse effects
  • Cataract*
  • Dexamethasone / therapeutic use
  • Double-Blind Method
  • Humans
  • Inflammation / drug therapy
  • Inflammation / etiology
  • Male
  • Ophthalmic Solutions / adverse effects
  • Treatment Outcome


  • Dexamethasone
  • Ophthalmic Solutions

Associated data

  • ClinicalTrials.gov/NCT04130802