Stimulation Therapy versus Artificial Tears for the Treatment of Post-LASIK (laser in situ keratomileusis) Dry Eye

Phase 2

Completed

• Conditions: Post-LASIK dry eye; Eye - Diseases / disorders of the eye; Eye - Normal eye development and function

• Registration Number: ACTRN12614000272695
• Lead Sponsor: Oculeve, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients meeting all criteria for appropriateness of LASIK surgery instituted by the treating centre with an established date for bilateral primary LASIK surgery

Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol

Normal lid anatomy, blinking function and closure

Corrected visual acuity of 20/25 (Snellen equivalent) or better in each eye

Exclusion Criteria

Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or electronic device

Diagnosed epilepsy with seizures within the past five years

Coagulation disorders such as haemophilia and thrombocytopenia

Active or uncontrolled severe systemic allergy, chronic seasonal allergies, rhinitis or sinusitis requiring treatment or active/untreated nasal infection at the time of the baseline examination

Punctal plugs

Contact lens wear during the study

Lacrimal, nasal or sinus neoplasia, significant trauma, or invasive surgery

Chronic or recurrent epistaxis, history of cocaine abuse, or Wegener’s granulomatosis

Participation in any clinical trial with a new active substance or a new device during the past three months

Women who are pregnant, planning a pregnancy or nursing at study entry

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A comparison between groups in mean Ocular Surface Disease Index score [At 3 months after start of study treatment];A comparison between groups in mean dry eye symptoms as assessed by a Visual Analogue Scale [At 3 months after start of study treatment ]

Secondary Outcome Measures

Name	Time	Method
A comparison between groups in mean Schirmer test score[At 3 months after start of study treatment];A comparison between groups in mean corneal staining score[At 3 months after start of study treatment]