ABSTRACT
Purpose: The purpose of the study was to evaluate, as a pilot trial, safety and tolerability of CAM-101 10% and 30% topical ophthalmic fibrinogen-depleted human platelet lysate (FD hPL) solution in patients with dry eye disease (DED) secondary to graft-versus-host disease (GvHD) after 6 weeks of treatment. Design: A phase I/II, pilot, prospective, multicenter, randomized, double-masked clinical trial. Participants: Patients with DED secondary to GvHD. Methods: Sixty-four adult patients were stratified by "symptom severity" (Ocular Surface Disease Index [OSDI], ocular discomfort Visual Analog Scale (VAS), ocular symptom frequency, and use of artificial tears) and then randomized 1:1:1 to CAM-101 (FD hPL) at 10% or 30% concentration or an electrolyte (Plasma-Lyte A) vehicle control, 1 drop in both eyes, 4 times daily, for 42 days. After 42 days, control patients were offered 42 days of open-label treatment with 30% FD hPL. Main Outcome Measures: Primary outcome safety measures were ocular and systemic adverse events and the number of patients in each group with clinically significant change from normal to abnormal in any ocular findings. Secondary outcomes were changes from baseline to day 42 in ocular discomfort, OSDI, fluorescein corneal staining, and lissamine green conjunctival staining relative to the vehicle control. The ocular symptom frequency was assessed on a 100-point VAS. Results: FD hPL 10% and 30% were safe and well tolerated. Relative to the vehicle control, significant decreases from baseline to day 42 were seen in the FD hPL 30% group with regard to ocular discomfort (mean decrease = -18.04; P = 0.018), frequency of burning/stinging (-20.23; P = 0.022), eye discomfort (-32.97; P < 0.001), eye dryness (-21.61; P = 0.020), pain (-15.12; P = 0.044), photophobia (-24.33; P = 0.0125), and grittiness (-20.08; P = 0.0185). Decreases were also seen for itching and foreign body sensation, though not statistically significant. Improvements were seen in tear breakup time (mean increase = 1.30 seconds; P = 0.082) and the investigator's global evaluation 4-point scale (mean decrease = -0.86; P = 0.026). Corneal fluorescein staining was not improved. The OSDI had a mean decrease of -8.88 compared to the vehicle, although not statistically significant. Conclusions: Fibrinogen-depleted human platelet lysate appears to be well tolerated, with no significant toxicity at concentrations of 10% and 30%. These initial data suggest some efficacy, especially for subjective outcome measures relative to baseline assessments and treatment with the vehicle, but larger studies are needed to confirm these effects.
ABSTRACT
PURPOSE: To assess the effect of preoperative topical nonsteroidal antiinflammatory drugs (NSAIDs) on postoperative pain after laser-assisted subepithelial keratectomy (LASEK) and to investigate their mechanism. SETTING: Severance Eye Hospital and Saeyan Eye Clinic, Seoul, South Korea. DESIGN: Prospective randomized clinical trial. METHODS: Participants in 2 related studies were assessed. Study 1 comprised patients scheduled for bilateral LASEK (Group 1) who were randomized to receive an NSAID in 1 eye and a placebo in the fellow eye 30, 20, and 10 minutes before LASEK. Postoperative pain, glare, tearing, and irritation were assessed using a visual analog scale. Study 2 comprised healthy subjects (Group 2) who were randomly divided into subgroups. The participants in these subgroups were randomized to receive ketorolac tromethamine 0.5% in 1 eye and placebo (ofloxacin 0.3%) in the fellow eye (Group 2A), proparacaine hydrochloride 0.5% in 1 eye and placebo in the fellow eye (Group 2B), or ketorolac tromethamine 0.5% in 1 eye and placebo in the fellow eye, followed 10 minutes later by 1 drop of proparacaine hydrochloride 0.5% in both eyes (Group 2C). In all 3 groups, corneal sensitivity was measured after 1, 2, and 6 hours. RESULTS: The mean postoperative pain score in the NSAID-pretreated eye was statistically significantly lower than in the placebo-pretreated eye 6, 12, and 24 hours postoperatively (P < .05). The mean corneal sensitivity was statistically significantly lower in the NSAID-treated eye than in the placebo-treated eye at 1 and 2 hours in Groups 2A and 2C (P < .05). CONCLUSION: Preoperative administration of topical NSAIDs before LASEK effectively reduces postoperative pain. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.
