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Ocular iontophoresis of EGP-437 (dexamethasone phosphate) in dry eye patients: results of a randomized clinical trial.

Patane MA, Cohen A, From S, Torkildsen G, Welch D, Ousler GW - Clin Ophthalmol (2011)

Bottom Line: The DP 7.5 treatment group exhibited statistically significant improvements in corneal staining (when comparing the differences between study entry and exit, 3 weeks, P = 0.039), OPI (immediately following the second treatment, P = 0.048) and ocular discomfort at follow-up visits (a week after the first treatment, P = 0.032; 24 hours after the second treatment, P = 0.0032).Treatment-emergent adverse events (AEs) were experienced by 87% of patients and were consistent across all treatment groups.Most AEs were mild and no severe AEs were observed.

View Article: PubMed Central - PubMed

Affiliation: Eyegate Pharmaceuticals, Inc, 100 Beaver Street, Waltham, MA 02453, USA. mpatane@eyegatepharma.com

ABSTRACT

Purpose: To assess safety and efficacy of EGP-437 (dexamethasone phosphate 40 mg/mL [DP]) in dry eye patients.

Methods: The study employed a prospective, single-center, double-masked design utilizing a Controlled Adverse Environment (CAE). Patients (n = 103) with confirmed signs and symptoms of dry eye syndrome were randomized into 1 of 3 iontophoresis treatment groups: 7.5 mA-min at 2.5 mA (DP 7.5, n = 41); 10.5 mA-min at 3.5 mA (DP 10.5, n = 37); or 10.5 mA-min at 3.5 mA (placebo, n = 25). Three CAE visits and 4 follow-up visits occurred over 3 weeks. Patients meeting enrollment criteria received iontophoresis in both eyes after the second CAE exposure (visit 3) and before the third CAE exposure (visit 5). Primary efficacy endpoints were corneal staining and ocular discomfort. Secondary endpoints included tear film break-up time, ocular protection index (OPI), and symptomatology.

Results: The DP 7.5 and DP 10.5 treatment groups showed statistically significant improvements in signs and symptoms of dry eye at various time points; however, the primary endpoints were not achieved. The DP 7.5 treatment group exhibited statistically significant improvements in corneal staining (when comparing the differences between study entry and exit, 3 weeks, P = 0.039), OPI (immediately following the second treatment, P = 0.048) and ocular discomfort at follow-up visits (a week after the first treatment, P = 0.032; 24 hours after the second treatment, P = 0.0032). Treatment-emergent adverse events (AEs) were experienced by 87% of patients and were consistent across all treatment groups. Most AEs were mild and no severe AEs were observed.

Conclusion: Ocular iontophoresis of EGP-437 demonstrated statistically and clinically significant improvements in signs and symptoms of dry eye syndrome within a CAE model.

No MeSH data available.


Related in: MedlinePlus

Patient disposition. The flow chart depicts the distribution of patients throughout the study as well as inclusion/exclusion numbers, study populations, and treatment arms.Abbreviations: DP, dexamethasone phosphate; ITT, intention to treat; PP, per protocol.
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f3-opth-5-633: Patient disposition. The flow chart depicts the distribution of patients throughout the study as well as inclusion/exclusion numbers, study populations, and treatment arms.Abbreviations: DP, dexamethasone phosphate; ITT, intention to treat; PP, per protocol.

Mentions: A total of 105 patients (mean age: 53 years, range 18 to 84; 32% male; 89% Caucasian) were randomized into three treatment groups comprising the ITT population. There were no significant differences between groups for age or male/female ratios. One hundred and three patients received study treatments via iontophoresis, comprising the safety population. Of the 105 randomized patients, 2 withdrew from the study prior to receiving treatment. The PP population consisted of the 83 patients who completed the study with no major protocol violations. The patient disposition is shown in Figure 3. Fourteen patients did not complete the study for various reasons, including two that received the wrong treatment. No patient was discontinued from the study as a result of a protocol deviation; however, six patients were excluded from the PP population for the following reasons: completed visit 5 out-of-window (n = 4), took exclusionary medication (n = 1), and received the wrong treatment via technician error (n = 1). Patients who received the wrong treatment were included in the ITT population as treated.


Ocular iontophoresis of EGP-437 (dexamethasone phosphate) in dry eye patients: results of a randomized clinical trial.

Patane MA, Cohen A, From S, Torkildsen G, Welch D, Ousler GW - Clin Ophthalmol (2011)

Patient disposition. The flow chart depicts the distribution of patients throughout the study as well as inclusion/exclusion numbers, study populations, and treatment arms.Abbreviations: DP, dexamethasone phosphate; ITT, intention to treat; PP, per protocol.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3104791&req=5

f3-opth-5-633: Patient disposition. The flow chart depicts the distribution of patients throughout the study as well as inclusion/exclusion numbers, study populations, and treatment arms.Abbreviations: DP, dexamethasone phosphate; ITT, intention to treat; PP, per protocol.
Mentions: A total of 105 patients (mean age: 53 years, range 18 to 84; 32% male; 89% Caucasian) were randomized into three treatment groups comprising the ITT population. There were no significant differences between groups for age or male/female ratios. One hundred and three patients received study treatments via iontophoresis, comprising the safety population. Of the 105 randomized patients, 2 withdrew from the study prior to receiving treatment. The PP population consisted of the 83 patients who completed the study with no major protocol violations. The patient disposition is shown in Figure 3. Fourteen patients did not complete the study for various reasons, including two that received the wrong treatment. No patient was discontinued from the study as a result of a protocol deviation; however, six patients were excluded from the PP population for the following reasons: completed visit 5 out-of-window (n = 4), took exclusionary medication (n = 1), and received the wrong treatment via technician error (n = 1). Patients who received the wrong treatment were included in the ITT population as treated.

Bottom Line: The DP 7.5 treatment group exhibited statistically significant improvements in corneal staining (when comparing the differences between study entry and exit, 3 weeks, P = 0.039), OPI (immediately following the second treatment, P = 0.048) and ocular discomfort at follow-up visits (a week after the first treatment, P = 0.032; 24 hours after the second treatment, P = 0.0032).Treatment-emergent adverse events (AEs) were experienced by 87% of patients and were consistent across all treatment groups.Most AEs were mild and no severe AEs were observed.

View Article: PubMed Central - PubMed

Affiliation: Eyegate Pharmaceuticals, Inc, 100 Beaver Street, Waltham, MA 02453, USA. mpatane@eyegatepharma.com

ABSTRACT

Purpose: To assess safety and efficacy of EGP-437 (dexamethasone phosphate 40 mg/mL [DP]) in dry eye patients.

Methods: The study employed a prospective, single-center, double-masked design utilizing a Controlled Adverse Environment (CAE). Patients (n = 103) with confirmed signs and symptoms of dry eye syndrome were randomized into 1 of 3 iontophoresis treatment groups: 7.5 mA-min at 2.5 mA (DP 7.5, n = 41); 10.5 mA-min at 3.5 mA (DP 10.5, n = 37); or 10.5 mA-min at 3.5 mA (placebo, n = 25). Three CAE visits and 4 follow-up visits occurred over 3 weeks. Patients meeting enrollment criteria received iontophoresis in both eyes after the second CAE exposure (visit 3) and before the third CAE exposure (visit 5). Primary efficacy endpoints were corneal staining and ocular discomfort. Secondary endpoints included tear film break-up time, ocular protection index (OPI), and symptomatology.

Results: The DP 7.5 and DP 10.5 treatment groups showed statistically significant improvements in signs and symptoms of dry eye at various time points; however, the primary endpoints were not achieved. The DP 7.5 treatment group exhibited statistically significant improvements in corneal staining (when comparing the differences between study entry and exit, 3 weeks, P = 0.039), OPI (immediately following the second treatment, P = 0.048) and ocular discomfort at follow-up visits (a week after the first treatment, P = 0.032; 24 hours after the second treatment, P = 0.0032). Treatment-emergent adverse events (AEs) were experienced by 87% of patients and were consistent across all treatment groups. Most AEs were mild and no severe AEs were observed.

Conclusion: Ocular iontophoresis of EGP-437 demonstrated statistically and clinically significant improvements in signs and symptoms of dry eye syndrome within a CAE model.

No MeSH data available.


Related in: MedlinePlus