Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye

• ClinicalTrials.gov Identifier: NCT01521507
• Recruitment Status: Completed
• First Posted: January 30, 2012
• Results First Posted: February 23, 2015
• Last Update Posted: February 23, 2015
• Sponsor: TearScience, Inc.
• Information provided by (Responsible Party): TearScience, Inc.

Tracking Information

• First Submitted Date: January 26, 2012
• First Posted Date: January 30, 2012
• Results First Submitted Date: February 4, 2015
• Results First Posted Date: February 23, 2015
• Last Update Posted Date: February 23, 2015
• Study Start Date: January 2012
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 4, 2015)

• Stage 1 Mean Change in Total Meibomian Gland Score From Baseline to 3 Months [ Time Frame: Baseline and 3 Months ]
  To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based on the sum of the secretion grades for all 15 glands over a range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. To be eligible for the study, the Baseline total meibomian gland score must have been 12 or less in each eye. Change = 3 Month score - Baseline Score.
• Stage 2 Mean Total Meibomian Gland Score at 12 Months [ Time Frame: 12 Months ]
  To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based on the sum of the secretion grades for all 15 glands over a range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. The total meibomian gland score at 12 Months was compared across subgroups, as defined below.

Original Primary Outcome Measures (submitted: January 26, 2012)

• Mean Change in Total Meibomian Gland Score from Baseline to 3 Months [ Time Frame: Baseline and 3 Months ]
• Mean Change in Total Meibomian Gland Score from Baseline to 6 Months [ Time Frame: Baseline, 6 Months ]
• Mean Change in Total Meibomian Gland Score from Baseline to 12 Months [ Time Frame: Baseline, 12 Months ]

• Change History: Complete list of historical versions of study NCT01521507 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: February 4, 2015)

• Stage 1 Mean Change in Total OSDI Score From Baseline to 3 Months [ Time Frame: Baseline, 3 Months ]
  Dry eye symptoms assessed using the OSDI questionnaire were sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The questionnaire evaluated the frequency problems with the eyes limited performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes felt uncomfortable was assessed in windy conditions, areas with low humidity, and air-conditioned areas. The frequency scale was 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time), and 4 (all of the time). The total OSDI score was calculated as the sum of frequency scores for all symptoms multiplied by 25 and divided by the number of questions answered with a range from 0 to 100. A lower total OSDI score represents less disability from dry eye symptoms. To be eligible for the study, the Baseline total OSDI score must have been 13 points or higher in each eye. Change=3 Months score-Baseline score.
• Stage 2 Mean Total OSDI Score at 12 Months [ Time Frame: 12 Months ]
  Dry eye symptoms assessed using the OSDI questionnaire were sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The questionnaire evaluated the frequency problems with the eyes limited performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes felt uncomfortable was assessed in windy conditions, areas with low humidity, and air-conditioned areas. Frequency scale was 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time), and 4 (all of the time). The total OSDI score was calculated as the sum of frequency scores for all symptoms multiplied by 25 and divided by the number of questions answered with a range from 0 to 100. A lower total OSDI score represents less disability from dry eye symptoms. The total OSDI score at 12 Months was compared across subgroups, as defined below.

Original Secondary Outcome Measures (submitted: January 26, 2012)

• Mean Change in Total OSDI Score from Baseline to 3 Months [ Time Frame: Baseline, 3 Months ]
• Mean Change in Total OSDI Score from Baseline to 6 Months [ Time Frame: Baseline, 6 Months ]
• Mean Change in Total OSDI Score from Baseline to 12 Months [ Time Frame: Baseline, 12 Months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye
• Official Title: Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye

Brief Summary

The study objective is to evaluate the long-term treatment effectiveness for adult patients with meibomian gland dysfunction (MGD) and evaporative dry eye by: 1) comparing the LipiFlow® System to a standardized daily warm compress and eyelid hygiene control therapy over a duration of 3 Months; and 2) evaluating the LipiFlow® alone and in combination with other MGD and dry eye treatments over a duration of up to 12 Months.

This is a post-market, non-significant risk, prospective and multi-center clinical trial divided into two stages. The first stage from enrollment to 3 Months is an open-label, randomized controlled design to compare the effectiveness of a single LipiFlow® System treatment to a standardized daily warm compress and eyelid hygiene Control therapy with Crossover LipiFlow® treatment of the Control subjects at 3 Months. The second stage, occurring between 3 and 12 Months, is an observational design to evaluate the effectiveness of LipiFlow® alone and in combination with other MGD and dry eye treatments over a duration of up to 12 Months. Subjects are entered into the following subgroups based on the subject's self-assessment of the adequacy of symptom relief and protocol-defined criteria for additional treatment.

1. One LipiFlow® Treatment: Subjects who receive only one LipiFlow® treatment.
2. Two LipiFlow® Treatments: Subjects who receive a second LipiFlow® treatment.
3. Combination Treatment: Subjects who receive one or two LipiFlow® treatments followed by other MGD or dry eye treatment, as prescribed by the physician.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Meibomian Gland Dysfunction
• Dry Eye

Intervention

• Device: LipiFlow System
  In-office device treatment for meibomian gland dysfunction by a physician
• Device: Warm Compress Therapy + Lid Scrub
  At-home daily warm compress therapy and lid hygiene
  Other Names:

  • EyeGiene Warm Compress Therapy
  • OCuSOFT Lid Scrub

Study Arms

• Experimental: LipiFlow System
  Treatment with LipiFlow System at randomization in Stage 1 of study
  Intervention: Device: LipiFlow System
• Active Comparator: Warm Compress and Lid Hygiene
  Control group receiving warm compress therapy and lid hygiene at randomization in Stage 1 of study and crossover LipiFlow System treatment in Stage 2 of study
  Interventions:

  • Device: LipiFlow System
  • Device: Warm Compress Therapy + Lid Scrub

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 26, 2012): 200
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 2014
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• At least 18 years old
• Tear film assessment that qualifies in both eyes
• Evidence of meibomian gland dysfunction and dry eye in both eyes
• Willingness to comply with study protocol

Exclusion Criteria:

• Systemic disease condition or medication that causes dry eye
• Use of other treatments for MGD or dry eye
• Ocular surgery, trauma, herpes infection, punctal plug insertion or punctal occlusion within past 3 months
• Active eye infection
• Active eye inflammation or recurrent inflammation within past 3 months
• Moderate to severe allergic conjunctivitis
• Severe eyelid inflammation
• Eyelid abnormality that affects lid function
• Ocular surface abnormality that may compromise corneal integrity
• Pregnant or nursing women
• Participation in another ophthalmic clinical trial within past 30 days

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01521507
• Other Study ID Numbers: LF-004
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: TearScience, Inc.
• Study Sponsor: TearScience, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Christy Stevens, O.D.; TearScience, Inc.

• PRS Account: TearScience, Inc.
• Verification Date: February 2015