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Trial Outcomes & Findings for Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients (NCT NCT01682460)

NCT ID: NCT01682460

Last Updated: 2017-06-05

Results Overview

Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= \>30 dots + confluence

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

At baseline (dispensing visit)

Results posted on

2017-06-05

Participant Flow

Participant milestones

Participant milestones
Measure
Refresh Tears Lubricant Eye Drops (Allergan)
Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Overall Study
STARTED
15
Overall Study
COMPLETED
11
Overall Study
NOT COMPLETED
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Refresh Tears Lubricant Eye Drops (Allergan)
Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Overall Study
Withdrawal by Subject
2
Overall Study
Did not meet inclusion criteria
2

Baseline Characteristics

Pilot Study on the Use of Artificial Tears to Treat Dry Eye in Glaucoma Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Refresh Tears Lubricant Eye Drops (Allergan)
n=11 Participants
Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Age, Continuous
68 years
STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male
Female
9 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
Region of Enrollment
Canada
11 participants
n=5 Participants

PRIMARY outcome

Timeframe: At baseline (dispensing visit)

Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= \>30 dots + confluence

Outcome measures

Outcome measures
Measure
Refresh Tears Lubricant Eye Drops (Allergan)
n=11 Participants
Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Ocular Surface Staining
1.65 units on a scale
Standard Deviation 0.80

PRIMARY outcome

Timeframe: After 1 week

Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= \>30 dots + confluence

Outcome measures

Outcome measures
Measure
Refresh Tears Lubricant Eye Drops (Allergan)
n=11 Participants
Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Ocular Surface Staining
1.55 units on a scale
Standard Deviation 0.88

PRIMARY outcome

Timeframe: After 1 month

Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= \>30 dots + confluence

Outcome measures

Outcome measures
Measure
Refresh Tears Lubricant Eye Drops (Allergan)
n=11 Participants
Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Ocular Surface Staining
1.29 units on a scale
Standard Deviation 0.89

PRIMARY outcome

Timeframe: At baseline (dispensing visit)

The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .

Outcome measures

Outcome measures
Measure
Refresh Tears Lubricant Eye Drops (Allergan)
n=11 Participants
Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Tear Break up Time With Fluorescein
2.88 seconds
Standard Deviation 2.01

PRIMARY outcome

Timeframe: After 1 week

The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .

Outcome measures

Outcome measures
Measure
Refresh Tears Lubricant Eye Drops (Allergan)
n=11 Participants
Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Tear Break up Time With Fluorescein
3.41 seconds
Standard Deviation 2.29

PRIMARY outcome

Timeframe: After 1 month

The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .

Outcome measures

Outcome measures
Measure
Refresh Tears Lubricant Eye Drops (Allergan)
n=11 Participants
Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Tear Break up Time With Fluorescein
4.01 seconds
Standard Deviation 2.76

SECONDARY outcome

Timeframe: At baseline (dispensing visit)

The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = \[(sum of scores for all questions answered)\*100\] / \[(total number of questions answered)\*4\]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).

Outcome measures

Outcome measures
Measure
Refresh Tears Lubricant Eye Drops (Allergan)
n=11 Participants
Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Ocular Surface Disease Index (OSDI) Score
25 units on a scale
Standard Deviation 16

SECONDARY outcome

Timeframe: 1 week after using artificial tears

The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = \[(sum of scores for all questions answered)\*100\] / \[(total number of questions answered)\*4\]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score).

Outcome measures

Outcome measures
Measure
Refresh Tears Lubricant Eye Drops (Allergan)
n=11 Participants
Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Ocular Surface Disease Index (OSDI) Score
18 units on a scale
Standard Deviation 11

SECONDARY outcome

Timeframe: 1 month after using artificial tears

The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = \[(sum of scores for all questions answered)\*100\] / \[(total number of questions answered)\*4\]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score).

Outcome measures

Outcome measures
Measure
Refresh Tears Lubricant Eye Drops (Allergan)
n=11 Participants
Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Ocular Surface Disease Index (OSDI) Score
15 units on a scale
Standard Deviation 13

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline (dispensing visit)

Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)

Outcome measures

Outcome measures
Measure
Refresh Tears Lubricant Eye Drops (Allergan)
n=11 Participants
Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Subjective Ratings of Comfort
80 units on a scale
Standard Deviation 14

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 week after using artificial tears

Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)

Outcome measures

Outcome measures
Measure
Refresh Tears Lubricant Eye Drops (Allergan)
n=11 Participants
Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Subjective Ratings of Comfort
92 units on a scale
Standard Deviation 8

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month after using artificial tears

Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)

Outcome measures

Outcome measures
Measure
Refresh Tears Lubricant Eye Drops (Allergan)
n=11 Participants
Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Subjective Ratings of Comfort
92 units on a scale
Standard Deviation 7

Adverse Events

Refresh Tears Lubricant Eye Drops (Allergan)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Refresh Tears Lubricant Eye Drops (Allergan)
n=11 participants at risk
Artificial tears eye drops QID for 1 month Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month
Eye disorders
Corneal marginal keratitis
9.1%
1/11 • Number of events 1

Additional Information

Research Manager

CCLR

Phone: 519-888-4742

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place