Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00691197
• Collaborator: (none)
• Enrollment: 246
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 35

Study Details

Study Description

Brief Summary

Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses

Condition or Disease	Intervention/Treatment	Phase
Ametropia	Device: Carboxymethylcellulose sodium and Glycerin; Device: Carboxymethylcellulose sodium	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 246 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Carboxymethylcellulose sodium and Glycerin Carboxymethylcellulose sodium and Glycerin based rewetting drop	Device: Carboxymethylcellulose sodium and Glycerin; Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.; Other Names: Optive™
Active Comparator: Carboxymethylcellulose sodium Carboxymethylcellulose sodium based rewetting drop	Device: Carboxymethylcellulose sodium; Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.; Other Names: Refresh Contacts®

Outcome Measures

Primary Outcome Measures

1. Best Corrected Visual Acuity [Change from Baseline at Day 90]

   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.

Secondary Outcome Measures

1. Corneal Staining [Day 90]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adapted contact lens wearer

Exclusion Criteria:

• Monovision lens wearer, ocular or systemic disease, pregnant or planning to become pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		San Diego	California	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Chair: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00691197
• Other Study ID Numbers: AG9689-002
• First Posted: Jun 5, 2008
• Last Update Posted: Jul 22, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Refractive Errors; Carboxymethylcellulose Sodium; Glycerol

Study Results

Participant Flow

Arm/Group Title	Carboxymethylcellulose Sodium and Glycerin	Carboxymethylcellulose Sodium
Arm/Group Description	Carboxymethylcellulose sodium and Glycerin based rewetting drop	Carboxymethylcellulose sodium based rewetting drop
Period Title: Overall Study
STARTED	166	80
COMPLETED	155	75
NOT COMPLETED	11	5

Baseline Characteristics

Arm/Group Title	Carboxymethylcellulose Sodium and Glycerin	Carboxymethylcellulose Sodium	Total
Arm/Group Description	Carboxymethylcellulose sodium and Glycerin based rewetting drop	Carboxymethylcellulose sodium based rewetting drop	Total of all reporting groups
Overall Participants	166	80	246
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	37.6 (11.94)	36.8 (11.54)	37.4 (11.80)
Sex: Female, Male (Count of Participants)
Female	122 73.5%	53 66.3%	175 71.1%
Male	44 26.5%	27 33.8%	71 28.9%

Outcome Measures

1. Primary Outcome

Title	Best Corrected Visual Acuity
Description	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.
Time Frame	Change from Baseline at Day 90

Outcome Measure Data

Analysis Population Description

Completed Population

Arm/Group Title	Carboxymethylcellulose Sodium and Glycerin	Carboxymethylcellulose Sodium
Arm/Group Description	Carboxymethylcellulose sodium and Glycerin based rewetting drop	Carboxymethylcellulose sodium based rewetting drop
Measure Participants	155	75
Better	0.65 0.4%	1.33 1.7%
No Change	98.06 59.1%	98.67 123.3%
Worse	1.29 0.8%	0 0%

2. Post-Hoc Outcome

Title	Patient Acceptability
Description	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)
Time Frame	Day 90

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Carboxymethylcellulose Sodium and Glycerin	Carboxymethylcellulose Sodium
Arm/Group Description	Carboxymethylcellulose sodium and Glycerin based rewetting drop	Carboxymethylcellulose sodium based rewetting drop
Measure Participants	161	79
Liked using the RD (160/78)	72.5 43.7%	82.1 102.6%
RD gave good comfort during day (161/79)	78.8 47.5%	84.8 106%
RD on CL gave good initial comfort (161/79)	49.0 29.5%	54.4 68%
At day's end,CL felt better after RD use (161/78)	51.6 31.1%	62.8 78.5%
Could wear CL longer when using RD (161/79)	46.6 28.1%	44.3 55.4%
Vision was normal soon after using RD (161/79)	85.7 51.6%	81.0 101.3%
Vision with CL was better after RD use (161/79)	31.0 18.7%	41.8 52.3%
Would likely purchase these RD (161/79)	50.4 30.4%	68.4 85.5%
Eyes felt better after CL removal (161/79)	38.5 23.2%	43.1 53.9%

3. Secondary Outcome

Title	Corneal Staining
Description	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
Time Frame	Day 90

Outcome Measure Data

Analysis Population Description

Completed Population

Arm/Group Title	Carboxymethylcellulose Sodium and Glycerin	Carboxymethylcellulose Sodium
Arm/Group Description	Carboxymethylcellulose sodium and Glycerin based rewetting drop	Carboxymethylcellulose sodium based rewetting drop
Measure Participants	155	75
Number [Participants]	0 0%	1 1.3%

4. Post-Hoc Outcome

Title	Patient Preference
Description	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).
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

Responders Completed Population

Arm/Group Title	Carboxymethylcellulose Sodium and Glycerin	Carboxymethylcellulose Sodium
Arm/Group Description	Carboxymethylcellulose sodium and Glycerin based rewetting drop	Carboxymethylcellulose sodium based rewetting drop
Measure Participants	79	41
Prefer SD over PSD	47.2 28.4%	41.5 51.9%
SD more comfortable overall than PSD	53.2 32%	34.1 42.6%

Adverse Events

Arm/Group Title	Carboxymethylcellulose Sodium and Glycerin		Carboxymethylcellulose Sodium
Arm/Group Description	Carboxymethylcellulose sodium and Glycerin based rewetting drop		Carboxymethylcellulose sodium based rewetting drop
All Cause Mortality
	Carboxymethylcellulose Sodium and Glycerin		Carboxymethylcellulose Sodium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Carboxymethylcellulose Sodium and Glycerin		Carboxymethylcellulose Sodium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/166 (0%)		0/79 (0%)
Other (Not Including Serious) Adverse Events
	Carboxymethylcellulose Sodium and Glycerin		Carboxymethylcellulose Sodium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/166 (9%)		11/79 (13.9%)
Eye disorders
Asthenopia	2/166 (1.2%)		0/79 (0%)
Dry eye	2/166 (1.2%)		2/79 (2.5%)
Eye discharge	3/166 (1.8%)		0/79 (0%)
Eye irritation	3/166 (1.8%)		1/79 (1.3%)
Ocular discomfort	2/166 (1.2%)		0/79 (0%)
Conjunctival oedema	1/166 (0.6%)		1/79 (1.3%)
Conjunctivitis allergic	0/166 (0%)		1/79 (1.3%)
Episcleritis	0/166 (0%)		1/79 (1.3%)
Eye pruritus	1/166 (0.6%)		2/79 (2.5%)
Limbal hyperaemia	1/166 (0.6%)		1/79 (1.3%)
Ocular hyperaemia	0/166 (0%)		1/79 (1.3%)
Skin and subcutaneous tissue disorders
Dermatitis allergic	0/166 (0%)		1/79 (1.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.