Trial Outcomes & Findings for A Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms (NCT NCT02028754)
NCT ID: NCT02028754
Last Updated: 2014-04-23
Results Overview
TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film.
COMPLETED
PHASE4
180 participants
Day 7
2014-04-23
Participant Flow
Participant milestones
| Measure |
Sodium Carboxymethylcellulose and Conventional Therapy
Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
Conventional Therapy
Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
90
|
|
Overall Study
COMPLETED
|
83
|
82
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms
Baseline characteristics by cohort
| Measure |
Sodium Carboxymethylcellulose and Conventional Therapy
n=90 Participants
Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
Conventional Therapy
n=90 Participants
Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.8 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
69.0 Years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
68.9 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: All patients with data at this time point
TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film.
Outcome measures
| Measure |
Sodium Carboxymethylcellulose and Conventional Therapy
n=85 Participants
Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
Conventional Therapy
n=85 Participants
Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
|---|---|---|
|
Tear Break-Up Time (TBUT) in the Study Eye
|
8.5 Seconds
Standard Deviation 5.5
|
6.6 Seconds
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: Day 30Population: All patients with data at this time point
TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film.
Outcome measures
| Measure |
Sodium Carboxymethylcellulose and Conventional Therapy
n=83 Participants
Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
Conventional Therapy
n=82 Participants
Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
|---|---|---|
|
Tear Break-Up Time (TBUT) in the Study Eye
|
9.0 Seconds
Standard Deviation 5.9
|
6.7 Seconds
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Day 7, Day 30Population: All patients with data at this time point
The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 3 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 3 points: 0=non-staining, 1=staining range \< 1/2 of the cornea, 2=staining range ≥ 1/2 of the cornea, and 3=regional whole staining of the cornea. The total score ranges from 0 to 9 points. The higher the staining score, the worse the dry eye condition.
Outcome measures
| Measure |
Sodium Carboxymethylcellulose and Conventional Therapy
n=85 Participants
Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
Conventional Therapy
n=85 Participants
Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
|---|---|---|
|
Fluorescein Staining Score in the Study Eye
Day 7
|
2.0 Scores on a Scale
Standard Deviation 2.8
|
1.8 Scores on a Scale
Standard Deviation 2.6
|
|
Fluorescein Staining Score in the Study Eye
Day 30 (N=83, 82)
|
1.1 Scores on a Scale
Standard Deviation 1.8
|
1.2 Scores on a Scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Day 7, Day 30Population: All patients with data at this time point
Conjunctival and corneal staining are evaluated following ocular administration of lissamine green dye in the study eye. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva and cornea are divided into 5 regions that are scored based on the extent of staining. Scores range from 0 to 3 points: 0=non-staining, 1=staining range \< 1/2 of the conjunctiva and cornea, 2=staining range ≥ 1/2 of the conjunctiva and cornea, and 3=regional whole staining of the conjunctiva and cornea. The total score ranges from 0 to 15 points. The higher the grade score, the worse the dry eye condition.
Outcome measures
| Measure |
Sodium Carboxymethylcellulose and Conventional Therapy
n=85 Participants
Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
Conventional Therapy
n=85 Participants
Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
|---|---|---|
|
Lissamine Green Staining Score in the Study Eye
Day 7
|
2.9 Scores on a Scale
Standard Deviation 3.3
|
2.6 Scores on a Scale
Standard Deviation 3.2
|
|
Lissamine Green Staining Score in the Study Eye
Day 30 (N=83,82)
|
2.1 Scores on a Scale
Standard Deviation 2.4
|
2.3 Scores on a Scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Day 7, Day 30Population: All patients with data at this time point
The Schirmer I test consists of anesthetic drops being placed into the lower eyelid of the study eye. Patients then close their eyes. Test paper is placed on the lower eyelid of the patient's closed eyes. The paper is then removed and the moisture length on the paper recorded. Shorter distances indicate worse dry eye symptoms.
Outcome measures
| Measure |
Sodium Carboxymethylcellulose and Conventional Therapy
n=85 Participants
Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
Conventional Therapy
n=85 Participants
Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
|---|---|---|
|
Results of Schirmer I Test With Anesthetics in the Study Eye
Day 7
|
11.8 Millimeters
Standard Deviation 5.6
|
12.5 Millimeters
Standard Deviation 6.8
|
|
Results of Schirmer I Test With Anesthetics in the Study Eye
Day 30 (N=83, 82)
|
12.7 Millimeters
Standard Deviation 6.1
|
12.6 Millimeters
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Day 7, Day 30Population: All patients with data at this time point
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms in the study eye. The OSDI consists of a 5-point scale (0=none of the time and 4 = all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability).
Outcome measures
| Measure |
Sodium Carboxymethylcellulose and Conventional Therapy
n=85 Participants
Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
Conventional Therapy
n=85 Participants
Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
|---|---|---|
|
Ocular Surface Disease Index (OSDI) Questionnaire Score in the Study Eye
Day 7
|
15.6 Scores on a Scale
Standard Deviation 16.8
|
18.1 Scores on a Scale
Standard Deviation 19.5
|
|
Ocular Surface Disease Index (OSDI) Questionnaire Score in the Study Eye
Day 30 (N=83, 82)
|
12.7 Scores on a Scale
Standard Deviation 11.3
|
14.2 Scores on a Scale
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: Day 7, Day 30Population: All patients with data at this time point
The following 11 subjective symptoms are evaluated in the study eye: foreign body sensation, photophobia, itching, pain in the eye, dry eye, eye heaviness, blurred vision, eye fatigue, eye discomfort, eye secretions and tears. Each of these symptoms is divided into 4 classes: no symptom=0; occasional symptoms=1; intermittent mild symptoms=2; and persistent obvious symptoms=3. The total score ranged from 0 (best) to 33 (worst).
Outcome measures
| Measure |
Sodium Carboxymethylcellulose and Conventional Therapy
n=85 Participants
Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
Conventional Therapy
n=85 Participants
Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
|
|---|---|---|
|
Subjective Symptom Total Score in the Study Eye
Day 7
|
6.1 Scores on a Scale
Standard Deviation 5.3
|
6.4 Scores on a Scale
Standard Deviation 5.2
|
|
Subjective Symptom Total Score in the Study Eye
Day 30 (N=83, 82)
|
5.1 Scores on a Scale
Standard Deviation 3.6
|
5.6 Scores on a Scale
Standard Deviation 4.0
|
Adverse Events
Sodium Carboxymethylcellulose and Conventional Therapy
Conventional Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER