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

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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:
Information provided by (Responsible Party):
TearScience, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Meibomian Gland Dysfunction
Dry Eye
Interventions Device: LipiFlow System
Device: Warm Compress Therapy + Lid Scrub
Enrollment 200
Recruitment Details Between February 19, 2012 and October 15, 2012, this study enrolled subjects with meibomian gland dysfunction (MGD) and evaporative dry eye from nine ophthalmic practices in the United States.
Pre-assignment Details A total of 274 subjects were consented and 200 subjects were randomized. Of the 74 subjects who were not randomized, 52 subjects did not meet the study eligibility criteria and 22 subjects elected not to participate prior to randomization or had not yet attended the Baseline visit when study enrollment was completed.
Arm/Group Title LipiFlow Treatment Warm Compress & Lid Hygiene, Then Crossover LipiFlow Treatment
Hide Arm/Group Description

Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.

In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief:

  1. One LipiFlow Treatment - After subjects received one LipiFlow treatment at randomization, no other MGD or dry eye treatment was prescribed for the study duration.
  2. Two LipiFlow Treatments - Subjects received a second LipiFlow treatment during Stage 2. No other MGD or dry eye treatment was prescribed for the study duration.
  3. Combination Treatment - After subjects received one or two LipiFlow treatments, they received other MGD or dry eye treatment, as prescribed by the physician.

Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3 months in Stage 1. Then, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.

In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief:

  1. One LipiFlow Treatment - After subjects received one LipiFlow treatment at crossover, no other MGD or dry eye treatment was prescribed for the study duration.
  2. Two LipiFlow Treatments - Subjects received a second LipiFlow treatment during Stage 2. No other MGD or dry eye treatment was prescribed for the study duration.
  3. Combination Treatment - After subjects received one or two LipiFlow treatments, they received other MGD or dry eye treatment, as prescribed by the physician.
Period Title: Stage 1: Randomized Design
Started 101 99
Received Initial Treatment (Tx) 99 98
Completed 98 94
Not Completed 3 5
Reason Not Completed
Device did not fit, No Treatment             2             0
Withdrawal by Subject             1             3
Lost to Follow-up             0             2
Period Title: Stage 2: Observational Design
Started 98 94
Received Crossover LipiFlow Tx 0 93
Received Only One LipiFlow Tx at 12 Mo 81 82
Received Other MGD Treatment at 12 Mo 11 9
Received 2nd LipiFlow Tx at 12 Mo 2 1
Completed 94 92
Not Completed 4 2
Reason Not Completed
Device did not fit, No Treatment             0             1
Withdrawal by Subject             3             1
Physician Decision             1             0
Arm/Group Title LipiFlow Treatment Warm Compress & Lid Hygiene Total
Hide Arm/Group Description Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study. Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1. Total of all reporting groups
Overall Number of Baseline Participants 101 99 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 99 participants 200 participants
56.3  (15.9) 56.1  (14.7) 56.2  (15.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 99 participants 200 participants
Female
74
  73.3%
68
  68.7%
142
  71.0%
Male
27
  26.7%
31
  31.3%
58
  29.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 99 participants 200 participants
Hispanic or Latino
7
   6.9%
7
   7.1%
14
   7.0%
Not Hispanic or Latino
94
  93.1%
92
  92.9%
186
  93.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 99 participants 200 participants
American Indian or Alaska Native
1
   1.0%
0
   0.0%
1
   0.5%
Asian
2
   2.0%
3
   3.0%
5
   2.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
98
  97.0%
96
  97.0%
194
  97.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 101 participants 99 participants 200 participants
101 99 200
Baseline Total Meibomian Gland Score  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 101 participants 99 participants 200 participants
6.2  (3.7) 6.3  (3.7) 6.2  (3.7)
Baseline Total OSDI Score  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 101 participants 99 participants 200 participants
45.6  (21.2) 51.8  (23.1) 48.7  (22.4)
Duration of Dry Eye Symptoms  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 99 participants 200 participants
6.9  (6.8) 8.7  (7.7) 7.8  (7.3)
Duration of MGD or Dry Eye Diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 99 participants 200 participants
5.3  (6.2) 5.5  (5.9) 5.4  (6.0)
1.Primary Outcome
Title Stage 1 Mean Change in Total Meibomian Gland Score From Baseline to 3 Months
Hide Description 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.
Time Frame Baseline and 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population (All Participants who were randomized and received at least partial LipiFlow treatment or used warm compress therapy at least once and had data available at 3 Months).
Arm/Group Title LipiFlow Treatment Warm Compress & Lid Hygiene
Hide Arm/Group Description:
Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
Overall Number of Participants Analyzed 98 94
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
11.6
(10.2 to 13.0)
4.5
(3.4 to 5.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LipiFlow Treatment, Warm Compress & Lid Hygiene
Comments The null and alternative hypotheses are H0: µt ≤ µc vs. Ha: µt > µc, where µt and µc are the mean changes in total meibomian gland scores from Baseline to 3 Months for the LipiFlow (test) and Warm Compress and Lid Hygiene (active control) groups, respectively. For the Stage 1 Primary Outcome, the minimum sample size was 24 subjects per group with a power of 90% and a one-sided alpha of 0.025.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Stage 1 primary and secondary outcomes were tested in order under a closed form testing method. Secondary outcome was tested only if primary outcome was statistically significant. If both outcomes were significant, overall study alpha was 0.025.
Method z-statistic
Comments p-value was based on z-statistic of the sum of weighted average of difference in scores between groups at each site divided by the sum of the weights.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LipiFlow Treatment, Warm Compress & Lid Hygiene
Comments Supportive multivariate mixed model was also performed for this outcome controlling for significant demographic and baseline characteristics.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Stage 2 Mean Total Meibomian Gland Score at 12 Months
Hide Description 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.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population (All participants who received at least partial LipiFlow or Crossover LipiFlow treatment and had data available at 12 Months). Two LipiFlow treatments subgroup was not analyzed because sample size was too small (n<5) for meaningful analysis.
Arm/Group Title LipiFlow Arm: One LipiFlow Treatment Subgroup LipiFlow Arm: Combination Treatment Subgroup Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup Warm Compress/Hygiene Arm: Combination Treatment Subgroup
Hide Arm/Group Description:

Subjects received a single, 12-minute, in-office LipiFlow treatment of both eyes after randomization in Stage 1.

In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration.

Subjects received a single, 12-minute, in-office LipiFlow treatment of both eyes after randomization in Stage 1.

In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at randomization) followed by other MGD or dry eye treatment, as prescribed by the physician.

After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.

In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration.

After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.

In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at crossover) or two LipiFlow treatments followed by other MGD or dry eye treatment, as prescribed by the physician.

Overall Number of Participants Analyzed 81 11 82 9
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
17.3
(15.8 to 18.7)
17.9
(13.1 to 22.7)
18.4
(16.7 to 20.1)
17.4
(13.2 to 21.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LipiFlow Arm: One LipiFlow Treatment Subgroup, LipiFlow Arm: Combination Treatment Subgroup, Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup, Warm Compress/Hygiene Arm: Combination Treatment Subgroup
Comments The null and alternative hypotheses for the Stage 2 Primary Outcome was: H0: µi= µj for all i and j where i≠j versus Ha: µi ≠ µj for at least one i and j, where µi is the mean total meibomian gland score at 12 Months for the ith subgroup. The null hypothesis was tested with a two-sided test at alpha=0.05. Since Stage 2 was an observational design, no minimum sample size was calculated for Stage 2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9098
Comments [Not Specified]
Method Mixed Models Analysis
Comments Stage 2 Primary Outcome was analyzed with a multivariate mixed model with the subgroup as a fixed effect while controlling for other covariates.
3.Secondary Outcome
Title Stage 1 Mean Change in Total OSDI Score From Baseline to 3 Months
Hide Description 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.
Time Frame Baseline, 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population (All participants who were randomized and received at least partial device treatment or used warm compress at least once and had data available at 3 Months).
Arm/Group Title LipiFlow Treatment Warm Compress & Lid Hygiene
Hide Arm/Group Description:
Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
Overall Number of Participants Analyzed 98 94
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-23.4
(-26.3 to -20.5)
-17.8
(-20.7 to -14.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LipiFlow Treatment, Warm Compress & Lid Hygiene
Comments The null and alternative hypotheses are H0: µt ≤ µc vs. Ha: µt > µc, where µt and µc are the mean changes in total OSDI scores from Baseline to 3 Months for the LipiFlow (test) and Warm Compress and Lid Hygiene (active control) groups, respectively. For the Stage 1 Secondary Outcome, the minimum sample size was 84 per group with a power of 80% and a one-sided alpha of 0.025.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0068
Comments Stage 1 primary and secondary outcomes were tested in order under a closed form testing method. Secondary outcome was tested only if primary outcome was statistically significant. If both outcomes were significant, overall study alpha was 0.025.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LipiFlow Treatment, Warm Compress & Lid Hygiene
Comments Supportive multivariate mixed model was also performed for this outcome controlling for significant demographic and baseline characteristics.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0419
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Stage 2 Mean Total OSDI Score at 12 Months
Hide Description 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.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (All participants who received at least a partial LipiFlow treatment or Crossover LipiFlow treatment and had data available at 12 Months). The Two LipiFlow treatments subgroup was not analyzed because the sample size (n<5) was too small for meaningful analysis.
Arm/Group Title LipiFlow Arm: One LipiFlow Treatment Subgroup LipiFlow Arm: Combination Treatment Subgroup Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup Warm Compress/Hygiene Arm: Combination Treatment Subgroup
Hide Arm/Group Description:

Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.

In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration.

Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.

In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at randomization) followed by other MGD or dry eye treatment, as prescribed by the physician.

After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.

In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration.

After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.

In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at crossover) or two LipiFlow treatments followed by other MGD or dry eye treatment, as prescribed by the physician.

Overall Number of Participants Analyzed 81 11 82 9
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
21.6
(18.3 to 24.9)
35.8
(24.5 to 47.1)
24.0
(20.5 to 27.6)
42.2
(25.5 to 58.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LipiFlow Arm: One LipiFlow Treatment Subgroup, LipiFlow Arm: Combination Treatment Subgroup, Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup, Warm Compress/Hygiene Arm: Combination Treatment Subgroup
Comments The null and alternative hypotheses for the Stage 2 Secondary Outcome was: H0: µi= µj for all i and j where i≠j versus Ha: µi ≠ µj for at least one i and j, where µi is the mean total OSDI score at 12 Months for the ith subgroup. The null hypothesis was tested with a two-sided test at alpha=0.05. Since Stage 2 was an observational design, no minimum sample size was calculated for Stage 2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0237
Comments Stage 2 Secondary Outcome was analyzed with a multivariate mixed model with the subgroup as a fixed effect while controlling for other covariates.
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame Adverse events were collected over 1 year.
Adverse Event Reporting Description Device-related adverse events were evaluated by arm/group. Events occurring during Stage 1 were assessed based on relationship to the LipiFlow Treatment or Warm Compress Therapy and Lid Hygiene. Events occurring in Stage 2 were assessed based on relationship to LipiFlow Treatment or Crossover LipiFlow Treatment.
 
Arm/Group Title LipiFlow Treatment Warm Compress & Lid Hygiene Crossover LipiFlow Treatment
Hide Arm/Group Description Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study. Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1. After using twice-daily, standardized warm compress therapy and lid hygiene for 3 months, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
All-Cause Mortality
LipiFlow Treatment Warm Compress & Lid Hygiene Crossover LipiFlow Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LipiFlow Treatment Warm Compress & Lid Hygiene Crossover LipiFlow Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/101 (0.00%)      0/99 (0.00%)      0/94 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LipiFlow Treatment Warm Compress & Lid Hygiene Crossover LipiFlow Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/101 (5.94%)      7/99 (7.07%)      4/94 (4.26%)    
Eye disorders       
Anterior Staphylococcal Blepharitis   1/101 (0.99%)  2 0/99 (0.00%)  0 0/94 (0.00%)  0
Blurry Vision   1/101 (0.99%)  1 1/99 (1.01%)  2 0/94 (0.00%)  0
Burning Sensation   0/101 (0.00%)  0 1/99 (1.01%)  2 1/94 (1.06%)  2
Chalazion   1/101 (0.99%)  1 0/99 (0.00%)  0 0/94 (0.00%)  0
Eye/Eyelid Discomfort/Pain   3/101 (2.97%)  4 1/99 (1.01%)  2 1/94 (1.06%)  2
Eyelid Edema/Swelling   1/101 (0.99%)  2 1/99 (1.01%)  2 1/94 (1.06%)  2
Eyelid Erythema/Redness   0/101 (0.00%)  0 1/99 (1.01%)  2 0/94 (0.00%)  0
Eyelid Irritation   0/101 (0.00%)  0 1/99 (1.01%)  2 0/94 (0.00%)  0
Eyelid Itching   1/101 (0.99%)  1 1/99 (1.01%)  1 0/94 (0.00%)  0
Eyelid Dermatitis   0/101 (0.00%)  0 2/99 (2.02%)  3 0/94 (0.00%)  0
Flashes/Ocular Migraine   1/101 (0.99%)  1 0/99 (0.00%)  0 0/94 (0.00%)  0
Gritty Sensation   0/101 (0.00%)  0 1/99 (1.01%)  2 0/94 (0.00%)  0
Hordeolum   1/101 (0.99%)  1 0/99 (0.00%)  0 0/94 (0.00%)  0
Increase/Worsening of MGD   0/101 (0.00%)  0 1/99 (1.01%)  2 0/94 (0.00%)  0
Increase/Worsening of Ocular Dryness   0/101 (0.00%)  0 1/99 (1.01%)  2 2/94 (2.13%)  4
Photophobia/Light Sensitivity   0/101 (0.00%)  0 1/99 (1.01%)  2 1/94 (1.06%)  1
Tearing   0/101 (0.00%)  1/99 (1.01%)  2 1/94 (1.06%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor can review communications for at least 30 days prior to public release with an extension for up to 45 additional days, if the Sponsor notifies the Investigator that the publication contains patentable material or Proprietary Information other than the study results. Upon Sponsor's written request, Investigator agrees to delete any Proprietary Information.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: TearScience, Inc.
Phone: 919-467-4007
EMail: cstevens@tearscience.com
Layout table for additonal information
Responsible Party: TearScience, Inc.
ClinicalTrials.gov Identifier: NCT01521507     History of Changes
Other Study ID Numbers: LF-004
First Submitted: January 26, 2012
First Posted: January 30, 2012
Results First Submitted: February 4, 2015
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015