Limits...
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

Ocular iontophoresis application. The photo shows the iontophoretic applicator placement on the eye.
© Copyright Policy
Related In: Results  -  Collection


getmorefigures.php?uid=PMC3104791&req=5

f2-opth-5-633: Ocular iontophoresis application. The photo shows the iontophoretic applicator placement on the eye.

Mentions: Visits 1 and 3 procedures were similar. Patients who continued to meet qualification criteria after visit 3 (day 0) CAE exposure were randomized into the study according to a predefined randomization code generated by an independent biostatistician, and received ocular iontophoresis of either: dexamethasone phosphate 40 mg/mL, 7.5 mA-min at 2.5 mA (DP 7.5); dexamethasone phosphate 40 mg/mL, 10.5 mA-min at 3.5 mA (DP 10.5); or sodium citrate buffer solution 100 mM, 10.5 mA-min at 3.5 mA (placebo). An unmasked technician identified the proper treatment group according to the randomization scheme, and then loaded the appropriate drug product from a standard vial into the foam reservoir of the ocular applicator. At least 1 hour after qualifying patients exited the CAE, patients were treated. Prior to placing the ocular iontophoresis applicator on the eye, the masked investigator instilled a topical anesthetic. The unmasked technician programmed the appropriate dose into the iontophoresis generator, concealed the device from the investigator, and then initiated treatment. The unmasked technician performed no other study procedures. The treatment process was then repeated for the other eye (Figure 2). Visit 5 procedures were the same as those at visit 3, but the visit 5 iontophoresis treatments were performed prior to CAE exposure.


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)

Ocular iontophoresis application. The photo shows the iontophoretic applicator placement on the eye.
© Copyright Policy
Related In: Results  -  Collection

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

f2-opth-5-633: Ocular iontophoresis application. The photo shows the iontophoretic applicator placement on the eye.
Mentions: Visits 1 and 3 procedures were similar. Patients who continued to meet qualification criteria after visit 3 (day 0) CAE exposure were randomized into the study according to a predefined randomization code generated by an independent biostatistician, and received ocular iontophoresis of either: dexamethasone phosphate 40 mg/mL, 7.5 mA-min at 2.5 mA (DP 7.5); dexamethasone phosphate 40 mg/mL, 10.5 mA-min at 3.5 mA (DP 10.5); or sodium citrate buffer solution 100 mM, 10.5 mA-min at 3.5 mA (placebo). An unmasked technician identified the proper treatment group according to the randomization scheme, and then loaded the appropriate drug product from a standard vial into the foam reservoir of the ocular applicator. At least 1 hour after qualifying patients exited the CAE, patients were treated. Prior to placing the ocular iontophoresis applicator on the eye, the masked investigator instilled a topical anesthetic. The unmasked technician programmed the appropriate dose into the iontophoresis generator, concealed the device from the investigator, and then initiated treatment. The unmasked technician performed no other study procedures. The treatment process was then repeated for the other eye (Figure 2). Visit 5 procedures were the same as those at visit 3, but the visit 5 iontophoresis treatments were performed prior to CAE exposure.

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