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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

Study visit schedule. Diagram represents the overall study timeline, delineating the temporal relationship between screening visits, Controlled Adverse Environment (CAE) and drug dosing sessions, and the recovery period.
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f1-opth-5-633: Study visit schedule. Diagram represents the overall study timeline, delineating the temporal relationship between screening visits, Controlled Adverse Environment (CAE) and drug dosing sessions, and the recovery period.

Mentions: The study included 7 visits over 3 weeks: 3 visits (visits 1, 3, and 5), in which patients were exposed to the CAE for 90 minutes, and 4 follow-up visits (visits 2, 4, 6, and 7) (Figure 1). At visit 1 (day −7 ± 2), patients provided written informed consent prior to any study procedures, and clinical staff collected medical and medication history data. Prior to and after CAE exposure, patients completed symptom questionnaires, had their blink rates captured using an infrared camera mounted on a headset, underwent ophthalmic exams including slit lamp biomicroscopy, and conjunctival redness grading based on the Ora 5-point scale (0 = none to 4 = severe). Ocular surface staining using the Ora28 regions was assessed on a 5-point scale (0 = none to 4 = confluent). Fluorescein and lissamine green stains were used – fluorescein to assess the cornea and lissamine green to evaluate the conjunctiva. Tear film break-up time (TFBUT) data were also captured. Ocular Protection Index (OPI) values were calculated by dividing the TFBUT by the mean interblink interval (derived from blink rate).30 A complete enumeration of procedures and assessments is provided in Table 1.


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)

Study visit schedule. Diagram represents the overall study timeline, delineating the temporal relationship between screening visits, Controlled Adverse Environment (CAE) and drug dosing sessions, and the recovery period.
© Copyright Policy
Related In: Results  -  Collection

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

f1-opth-5-633: Study visit schedule. Diagram represents the overall study timeline, delineating the temporal relationship between screening visits, Controlled Adverse Environment (CAE) and drug dosing sessions, and the recovery period.
Mentions: The study included 7 visits over 3 weeks: 3 visits (visits 1, 3, and 5), in which patients were exposed to the CAE for 90 minutes, and 4 follow-up visits (visits 2, 4, 6, and 7) (Figure 1). At visit 1 (day −7 ± 2), patients provided written informed consent prior to any study procedures, and clinical staff collected medical and medication history data. Prior to and after CAE exposure, patients completed symptom questionnaires, had their blink rates captured using an infrared camera mounted on a headset, underwent ophthalmic exams including slit lamp biomicroscopy, and conjunctival redness grading based on the Ora 5-point scale (0 = none to 4 = severe). Ocular surface staining using the Ora28 regions was assessed on a 5-point scale (0 = none to 4 = confluent). Fluorescein and lissamine green stains were used – fluorescein to assess the cornea and lissamine green to evaluate the conjunctiva. Tear film break-up time (TFBUT) data were also captured. Ocular Protection Index (OPI) values were calculated by dividing the TFBUT by the mean interblink interval (derived from blink rate).30 A complete enumeration of procedures and assessments is provided in Table 1.

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