Symptoms and General Pathology

All Conditions

Eye Diseases

Neoplasms

Syndrome

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Meibomian Gland Dysfunction

Chalazion

Keratoconjunctivitis

Lacrimal Apparatus Diseases

Conjunctivitis

Conjunctival Diseases

Keratitis

Corneal Diseases

Eyelid Diseases

Cysts

Treatment with experimental Manual Mini System

Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase

In-office device treatment for meibomian gland dysfunction by a physician

Manual Mini System

iHeat Portable Warm Compress Therapy

Christy Stevens, OD

The objective of this study is to evaluate the clinical utility, safety and effectiveness of the Manual Mini System compared to standardized warm compress therapy for application of controlled, localized heat therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.

Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

Randomized Clinical Trial for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

Evaluation of secretion characteristics from the gland orifices along the lower eyelid. Assessment was based on the grading scale: 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated), 0 (no secretion). The total meibomian gland secretion score was the sum of the grades for all 15 glands with a range of 0 to 45.

Number of eyes for which a device-related AE occurred

Tear break-up time measured under a slit lamp biomicroscope following instillation of fluorescein dye in the eye. Time was measured in seconds with a maximum of 20. Higher tear break-up time indicates better tear film stability.

Standard Patient Evaluation of Eye Dryness questionnaire. Assessment of subjects' frequency and severity of dry eye symptoms. The total score was calculated as the sum scores for all symptoms over a range of 0 to 28. A lower total SPEED score represents less frequent and/or less severe symptoms.

Corneal staining score in five corneal regions, evaluated on a scale from 0 (none), 1 (mild), 2 (moderate) to 3 (severe). The sum of the five corneal staining scores was on a scale from 0 to 15. A lower grade indicates less corneal surface desiccation.

Intraocular pressure (IOP) was evaluated by Goldmann applanation tonometry. Change in IOP from Baseline was assessed to confirm safety.

Measurement of BSCVA at a distance using a logMAR chart under standard illumination. The logMAR ranged from -0.30 to 1.0. A lower logMAR value is a better visual acuity.

Subject-reported numeric score reflecting low or high intensity. Scores ranged from 0 to 10, with 0 being no discomfort or pain and 10 being intolerable pain.

TearScience, Inc.

Warm Compress Therapy

Total

Age Continuous

Sex: Female, Male

Baseline (N=130, 136)

2 Weeks (N=130, 136)

4 Weeks (N=128, 132)

Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.

Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)

Results presented are of the Intent to Treat Population.

Incidence of Device-related Adverse Events

Dry Eye Symptoms (Total SPEED Score)

Baseline

2 Weeks

4 Weeks

Results presented are of the Intent to Treat Population. 4 Weeks data for the Control group are after treatment crossover.

Ocular Surface Staining (Corneal Staining Sum Score)

Baseline (N=138, 140)

Immediate Post-Treatment (N=138, 140)

4 Weeks (138, 136)

Results presented are of the Intent to Treat population. Post-Treatment results for the Control group are before crossover treatment. 4 Weeks results for the Control group are after crossover treatment.

Intraocular Pressure

2 Weeks (N=136, 136)

4 Weeks (N=138, 136)

Results presented are of the Intent to Treat population. 2 Weeks data for the Control group are after control treatment, but before crossover treatment. 4 Weeks data for the Control group are after crossover treatment.

(LogMAR) Best Spectacle Corrected Visual Acuity

During Treatment (N=138, 140)

1 Day (N=138)

Results presented are of the Intent to Treat population. Only the Manual Mini group underwent a 1 day assessment.

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