Trial Outcomes & Findings for Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear (NCT NCT00691197)
NCT ID: NCT00691197
Last Updated: 2015-07-22
Results Overview
Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye.
COMPLETED
PHASE2/PHASE3
246 participants
Change from Baseline at Day 90
2015-07-22
Participant Flow
Participant milestones
| Measure |
Carboxymethylcellulose Sodium and Glycerin
Carboxymethylcellulose sodium and Glycerin based rewetting drop
|
Carboxymethylcellulose Sodium
Carboxymethylcellulose sodium based rewetting drop
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
80
|
|
Overall Study
COMPLETED
|
155
|
75
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear
Baseline characteristics by cohort
| Measure |
Carboxymethylcellulose Sodium and Glycerin
n=166 Participants
Carboxymethylcellulose sodium and Glycerin based rewetting drop
|
Carboxymethylcellulose Sodium
n=80 Participants
Carboxymethylcellulose sodium based rewetting drop
|
Total
n=246 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.6 Years
STANDARD_DEVIATION 11.94 • n=113 Participants
|
36.8 Years
STANDARD_DEVIATION 11.54 • n=163 Participants
|
37.4 Years
STANDARD_DEVIATION 11.80 • n=160 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=113 Participants
|
53 Participants
n=163 Participants
|
175 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=113 Participants
|
27 Participants
n=163 Participants
|
71 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline at Day 90Population: Completed Population
Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye.
Outcome measures
| Measure |
Carboxymethylcellulose Sodium and Glycerin
n=155 Participants
Carboxymethylcellulose sodium and Glycerin based rewetting drop
|
Carboxymethylcellulose Sodium
n=75 Participants
Carboxymethylcellulose sodium based rewetting drop
|
|---|---|---|
|
Best Corrected Visual Acuity
Better
|
0.65 Percentage of Participants
|
1.33 Percentage of Participants
|
|
Best Corrected Visual Acuity
No Change
|
98.06 Percentage of Participants
|
98.67 Percentage of Participants
|
|
Best Corrected Visual Acuity
Worse
|
1.29 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 90Population: Completed Population
Corneal staining of greater or equal to grade 2 at day 90. Grading scale: 0 = None Present; 1 = Trace Finding; 2 = Mild Finding; 3 = Moderate Finding; 4 = Severe Finding
Outcome measures
| Measure |
Carboxymethylcellulose Sodium and Glycerin
n=155 Participants
Carboxymethylcellulose sodium and Glycerin based rewetting drop
|
Carboxymethylcellulose Sodium
n=75 Participants
Carboxymethylcellulose sodium based rewetting drop
|
|---|---|---|
|
Corneal Staining
|
0 Participants
|
1 Participants
|
POST_HOC outcome
Timeframe: Day 90Population: Intent to Treat Population
A questionnaire was administered to all patients to evaluate the acceptability of the Rewetting Drops (RD) with use with Contact Lenses (CL). Table below shows the percentage of participants responding either "Agree" or "Strongly Agree" at day 90. Number of participants answering question is indicated as (number of Test subjects/number of Control subjects)
Outcome measures
| Measure |
Carboxymethylcellulose Sodium and Glycerin
n=161 Participants
Carboxymethylcellulose sodium and Glycerin based rewetting drop
|
Carboxymethylcellulose Sodium
n=79 Participants
Carboxymethylcellulose sodium based rewetting drop
|
|---|---|---|
|
Patient Acceptability
Eyes felt better after CL removal (161/79)
|
38.5 Percentage of Participants
|
43.1 Percentage of Participants
|
|
Patient Acceptability
Liked using the RD (160/78)
|
72.5 Percentage of Participants
|
82.1 Percentage of Participants
|
|
Patient Acceptability
RD gave good comfort during day (161/79)
|
78.8 Percentage of Participants
|
84.8 Percentage of Participants
|
|
Patient Acceptability
RD on CL gave good initial comfort (161/79)
|
49.0 Percentage of Participants
|
54.4 Percentage of Participants
|
|
Patient Acceptability
At day's end,CL felt better after RD use (161/78)
|
51.6 Percentage of Participants
|
62.8 Percentage of Participants
|
|
Patient Acceptability
Could wear CL longer when using RD (161/79)
|
46.6 Percentage of Participants
|
44.3 Percentage of Participants
|
|
Patient Acceptability
Vision was normal soon after using RD (161/79)
|
85.7 Percentage of Participants
|
81.0 Percentage of Participants
|
|
Patient Acceptability
Vision with CL was better after RD use (161/79)
|
31.0 Percentage of Participants
|
41.8 Percentage of Participants
|
|
Patient Acceptability
Would likely purchase these RD (161/79)
|
50.4 Percentage of Participants
|
68.4 Percentage of Participants
|
POST_HOC outcome
Timeframe: Day 30Population: Responders Completed Population
Percentage of patients who used pre-study rewetting drops and answered "Agree" or "Strongly Agree" when asked if they preferred the study drops (SD) over their pre-study drops(PSD).
Outcome measures
| Measure |
Carboxymethylcellulose Sodium and Glycerin
n=79 Participants
Carboxymethylcellulose sodium and Glycerin based rewetting drop
|
Carboxymethylcellulose Sodium
n=41 Participants
Carboxymethylcellulose sodium based rewetting drop
|
|---|---|---|
|
Patient Preference
Prefer SD over PSD
|
47.2 Percentage of participants
|
41.5 Percentage of participants
|
|
Patient Preference
SD more comfortable overall than PSD
|
53.2 Percentage of participants
|
34.1 Percentage of participants
|
Adverse Events
Carboxymethylcellulose Sodium and Glycerin
Carboxymethylcellulose Sodium
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Carboxymethylcellulose Sodium and Glycerin
n=166 participants at risk
Carboxymethylcellulose sodium and Glycerin based rewetting drop
|
Carboxymethylcellulose Sodium
n=79 participants at risk
Carboxymethylcellulose sodium based rewetting drop
|
|---|---|---|
|
Eye disorders
Asthenopia
|
1.2%
2/166
|
0.00%
0/79
|
|
Eye disorders
Dry eye
|
1.2%
2/166
|
2.5%
2/79
|
|
Eye disorders
Eye discharge
|
1.8%
3/166
|
0.00%
0/79
|
|
Eye disorders
Eye irritation
|
1.8%
3/166
|
1.3%
1/79
|
|
Eye disorders
Ocular discomfort
|
1.2%
2/166
|
0.00%
0/79
|
|
Eye disorders
Conjunctival oedema
|
0.60%
1/166
|
1.3%
1/79
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/166
|
1.3%
1/79
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/166
|
1.3%
1/79
|
|
Eye disorders
Episcleritis
|
0.00%
0/166
|
1.3%
1/79
|
|
Eye disorders
Eye pruritus
|
0.60%
1/166
|
2.5%
2/79
|
|
Eye disorders
Limbal hyperaemia
|
0.60%
1/166
|
1.3%
1/79
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/166
|
1.3%
1/79
|
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 more than 60 days but less than or equal to 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