Wednesday, February 1, 2012

Abstract: VisMed vs Optive

Patients apparently did no worse on Optive than in Vismed.

Randomized, phase III study comparing osmoprotective carboxymethylcellulose with sodium hyaluronate in dry eye disease.

To compare a treatment containing carboxymethylcellulose (CMC) and the osmoprotective (OsPr) compatible osmolytes erythritol, L-carnitine, and glycerin (OsPr-CMC) with a standard sodium hyaluronate (Na-HY) formulation in patients with dry eye disease.

This was a 3-month, phase III, noninferiority study. Patients were randomized 1:1 to receive OsPr-CMC (OPTIVE®) or Na-HY (VISMED®). The primary efficacy outcome was the mean change from baseline in total ocular staining at day 35, scored using the 15-point Oxford scale. Noninferiority was assessed using the adjusted means. The secondary efficacy outcome was change in ocular surface disease index (OSDI) score from baseline to day 35. Other outcomes included tear osmolarity, Schirmer-I test score, OSDI, ease of use, patient acceptability, tolerability, and safety.

A total of 82 patients were randomized. The primary efficacy analysis was per protocol (OsPr-CMC, n=37; Na-HY, n=29). OsPr-CMC was noninferior to Na-HY in terms of adjusted mean change (SE) in ocular staining score at day 35: -2.0 (0.33) with OsPr-CMC vs -1.7 (0.37) with Na-HY. Similar improvements were seen in tear osmolarity, Schirmer-I test score, OSDI, and ocular staining for OsPr-CMC and Na-HY. More patients treated with OsPr-CMC vs Na-HY liked using their eyedrops, reported that their eyes felt comfortable, and found the treatment easy to use. Both treatments were well tolerated, with no serious treatment-related adverse events.

Compared with Na-HY, OsPr-CMC was noninferior in terms of efficacy and safety, preferred by patients, and easier to use. Osmoprotection using OsPr-CMC therefore represents a viable option for dry eye disease management.

Eur J Ophthalmol. 2012 Jan 27:0. doi: 10.5301/ejo.5000117. [Epub ahead of print]
Baudouin C, Cochener B, Pisella PJ, Girard B, Pouliquen P, Cooper H, Creuzot-Garcher C.
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris - France; Institut de la Vision, UMRS 968, UPMC, Paris - France.

Monday, January 30, 2012

Drug news: Seikagaku SI-614

Hyaluronate drop starting Phase II in the US.

Seikagaku Initiates a Phase II Clinical Trial in the United States for SI-614, Indicated for Treatment of Dry Eye

Tokyo, Japan, January, 2012—Seikagaku Corporation (hereafter “Seikagaku”) (head office: Chiyoda-ku, Tokyo) hereby announces that SI-614 has entered into a Phase II clinical trial in the United States (U.S.) for the treatment of dry eye....

SI-614 is a modified hyaluronate with an excellent tear film stabilizing effect that is produced by Seikagaku’s proprietary technology. Ocular instillation of SI-614 is expected to improve the tear film instability of the three layers (lipid layer, aqueous layer, and mucin layer) and accompanied symptoms found in dry eye patients....

Abstract: Blephagel

From what I've read of user comments on DryEyeTalk, patient acceptance of this product varies as much as it does with any of the others (Ocusoft, Sterilid and so on).

Tolerability and acceptability of Blephagel: a novel eyelid hygiene aqueous gel.

Commonly associated with dry eye, blepharitis is the most commonly encountered disorder in general ophthalmologic practice. Although anti-infective and anti-inflammatory therapies are available, eyelid hygiene is the cornerstone of effective management. A variety of products have been used to assist and encourage eyelid cleansing and massage. The present study examines the ocular and periocular tolerability and acceptability of Blephagel, a cosmetic, poloxamer-containing gel designed specifically for cleansing the eyelid in subjects with sensitive skin or eyes or contact lens users. Subjects with blepharitis and sensitive skin or eyes, a history of atopy, or who use contact lenses applied Blephagel twice daily at home. Clinical ophthalmologic examinations were conducted before and 21 days after aqueous gel application, and subjects completed a questionnaire on the acceptability of the preparation. Thirty-three predominantly female subjects entered and completed the study. A total of 36% of the subjects had used similar products in the past, 21% regularly. Upon questioning by the ophthalmologist, 85% of the subjects reported acceptability of the preparation as good to very good, and 73% rated the efficacy as good to very good. There were minor but statistically non-significant changes in fluorescein tear breakup time and visual acuity before and after 21 days of aqueous gel application. The questionnaire results indicated that the subjects found the product to be effective for cleansing the eyelids of mucus and squama around eyelash roots. Moreover, cosmetic qualities, sensation in use, and acceptability were also appreciated. No subject reported any adverse event considered to be related to the aqueous gel. Although the safety of Blephagel has already been established in standard tests, the current results suggest that it is also pleasant to use and acceptable to blepharitis patients with sensitive skin as an aid to an eyelid hygiene regime.

Clin Ophthalmol. 2012;6:71-7. Epub 2012 Jan 11.
Doan S.
Department of Ophthalmology, Bichat Hospital and Foundation, Paris, France.

Abstract: Pediatric ocular rosacea

GREAT reminder not to miss this possible diagnosis even in kids!

Pediatric ocular rosacea: 2 cases.

To report the clinical course of 2 pediatric ocular rosacea cases with a significant delay until diagnosis.

We report 2 interventional case reports. Case 1 is a 10-year-old boy with 2 years of recurrent bilateral blepharitis, repetition chalazion, conjunctival hyperemia, and corneal ulcers, without response to topical antibiotics or topical and systemic steroids. Case 2 is a 9-year-old girl with keratoconjunctivitis and repetition chalazion since she was 2 years old, without improvement after consulting several ophthalmologists and performing several treatments throughout those years.

Rapid response to systemic erythromycin with marked improvement of both cases within a few weeks.

Ocular rosacea is frequently misdiagnosed, particularly in the pediatric population. To our knowledge, this report demonstrates a case with the longest history before diagnosis (7 years) and another case in which a conjunctival biopsy was performed.

Eur J Ophthalmol. 2012 Jan 3:0. doi: 10.5301/ejo.5000103. [Epub ahead of print]
Miguel AI, Salgado MB, Lisboa MS, Henriques F, Paiva MC, Castela GP.
Department of Ophthalmology, Centro Hospitalar de Coimbra, Coimbra - Portugal.