Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms

This study has been completed.

Sponsor:

Information provided by:

Allergan

ClinicalTrials.gov Identifier:

NCT00761202

First received: September 25, 2008

Last updated: January 12, 2010

Last verified: January 2010

History of Changes

Results First Received: January 12, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Treatment
Condition:	Dry Eye Syndromes
Interventions:	Drug: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE® Drug: Sodium hyaluronate

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Carboxymethylcellulose and Glycerin	No text entered.
Sodium Hyaluronate	No text entered.

Participant Flow: Overall Study

	Carboxymethylcellulose and Glycerin	Sodium Hyaluronate
STARTED	22	28
COMPLETED	21	26
NOT COMPLETED	1	2

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Carboxymethylcellulose and Glycerin	No text entered.
Sodium Hyaluronate	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Carboxymethylcellulose and Glycerin	Sodium Hyaluronate	Total
Number of Participants [units: participants]	21	26	47
Age [units: years] Mean ± Standard Deviation	44.8 ± 16.4	39.9 ± 14.8	42.0 ± 16.0
Gender [units: participants]
Female	16	20	36
Male	5	6	11

Outcome Measures

Hide All Outcome Measures

1. Primary:

Conjunctival Staining by Lissamine Green [ Time Frame: week 1, month 1 ]

Measure Type	Primary
Measure Title	Conjunctival Staining by Lissamine Green
Measure Description	Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)
Time Frame	week 1, month 1
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat Population

Reporting Groups

	Description
Carboxymethylcellulose and Glycerin	No text entered.
Sodium Hyaluronate	No text entered.

Measured Values

	Carboxymethylcellulose and Glycerin	Sodium Hyaluronate
Number of Participants Analyzed [units: participants]	21	26
Conjunctival Staining by Lissamine Green [units: Percent]
Week 1 - None	50.0	53.8
Week 1 - Trace	17.5	15.4
Week 1 - Mild	17.5	25.0
Week 1 - Moderate	15.0	5.8
Week 1 - Severe	0.0	0.0
Month 1 - None	78.6	50.0
Month 1 - Trace	11.9	17.3
Month 1 - Mild	9.5	25.0
Month 1 - Moderate	0.0	7.7
Month 1 - Severe	0.0	0.0

No statistical analysis provided for Conjunctival Staining by Lissamine Green

2. Secondary:

Corneal Staining by Fluorescein [ Time Frame: week 1, month 1 ]

Measure Type	Secondary
Measure Title	Corneal Staining by Fluorescein
Measure Description	Percentage of cases of limbal staining by sodium fluorescein at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)
Time Frame	week 1, month 1
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat Population

Reporting Groups

	Description
Carboxymethylcellulose and Glycerin	No text entered.
Sodium Hyaluronate	No text entered.

Measured Values

	Carboxymethylcellulose and Glycerin	Sodium Hyaluronate
Number of Participants Analyzed [units: participants]	21	26
Corneal Staining by Fluorescein [units: Percent]
Week 1 - None	45.0	57.7
Week 1 - Trace	25.0	15.4
Week 1 - Mild	15.0	25.0
Week 1 - Moderate	15.0	1.9
Week 1 - Severe	0.0	0.0
Month 1 - None	73.8	51.9
Month 1 - Trace	21.4	15.4
Month 1 - Mild	4.8	26.9
Month 1 - Moderate	0.0	5.8
Month 1 - Severe	0.0	0.0

No statistical analysis provided for Corneal Staining by Fluorescein

3. Secondary:

Conjunctival Hyperaemia [ Time Frame: week 1, month 1 ]

Measure Type	Secondary
Measure Title	Conjunctival Hyperaemia
Measure Description	Percentage of conjunctival response reported in terms of limbal hyperaemia for the worst responses over the area at each point on a five point scale (0=clear/white conjunctiva, 1=slight redness, 2=Mild redness, 3=Moderate redness, 4=Severe redness)
Time Frame	week 1, month 1
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat Population

Reporting Groups

	Description
Carboxymethylcellulose and Glycerin	No text entered.
Sodium Hyaluronate	No text entered.

Measured Values

	Carboxymethylcellulose and Glycerin	Sodium Hyaluronate
Number of Participants Analyzed [units: participants]	21	26
Conjunctival Hyperaemia [units: Percent]
Week 1 - Clear/White	5.0	3.8
Week 1 - Slight	75.0	59.6
Week 1 - Mild	17.5	36.5
Week 1 - Moderate	2.5	0.0
Week 1 - Severe	0.0	0.0
Month 1 - Clear/White	0.0	0.0
Month 1 - Slight	71.4	71.2
Month 1 - Mild	28.6	28.8
Month 1 - Moderate	0.0	0.0
Month 1 - Severe	0.0	0.0

No statistical analysis provided for Conjunctival Hyperaemia

4. Secondary:

Ocular Comfort and Ocular Symptoms on Visual Analogue Scale [ Time Frame: week 1, month 1 ]

Measure Type	Secondary
Measure Title	Ocular Comfort and Ocular Symptoms on Visual Analogue Scale
Measure Description	Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)
Time Frame	week 1, month 1
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat Population

Reporting Groups

	Description
Carboxymethylcellulose and Glycerin	No text entered.
Sodium Hyaluronate	No text entered.

Measured Values

	Carboxymethylcellulose and Glycerin	Sodium Hyaluronate
Number of Participants Analyzed [units: participants]	21	26
Ocular Comfort and Ocular Symptoms on Visual Analogue Scale [units: Units on a scale] Mean ± Standard Deviation
Ocular Comfort - Waking (Wk.1)	67.05 ± 24.90	58.81 ± 24.73
Ocular Comfort - Daytime (Wk.1)	63.20 ± 22.05	68.21 ± 19.48
Ocular Comfort - Evening (Wk.1)	57.15 ± 26.30	63.38 ± 23.71
Ocular Comfort - Waking (Mo.1)	65.05 ± 23.48	63.56 ± 28.79
Ocular Comfort - Daytime (Mo.1)	68.57 ± 17.25	70.48 ± 23.21
Ocular Comfort - Evening (Mo.1)	60.38 ± 23.29	65.06 ± 23.44

No statistical analysis provided for Ocular Comfort and Ocular Symptoms on Visual Analogue Scale

5. Secondary:

Comparison of Eyedrops Usage [ Time Frame: Month 1 ]

Measure Type	Secondary
Measure Title	Comparison of Eyedrops Usage
Measure Description	Average daily eyedrop use
Time Frame	Month 1
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat Population

Reporting Groups

	Description
Carboxymethylcellulose and Glycerin	No text entered.
Sodium Hyaluronate	No text entered.

Measured Values

	Carboxymethylcellulose and Glycerin	Sodium Hyaluronate
Number of Participants Analyzed [units: participants]	21	26
Comparison of Eyedrops Usage [units: drops/day] Mean ± Standard Deviation	3.7 ± 1.4	3.3 ± 1.0

No statistical analysis provided for Comparison of Eyedrops Usage

6. Secondary:

Lipid Layer Pattern Assessment [ Time Frame: Week 1, month 1 ]

Measure Type	Secondary
Measure Title	Lipid Layer Pattern Assessment
Measure Description	Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.
Time Frame	Week 1, month 1
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat Population

Reporting Groups

	Description
Carboxymethylcellulose and Glycerin	No text entered.
Sodium Hyaluronate	No text entered.

Measured Values

	Carboxymethylcellulose and Glycerin	Sodium Hyaluronate
Number of Participants Analyzed [units: participants]	21	26
Lipid Layer Pattern Assessment [units: Lipid Layer Mixing Pattern] Median ( Full Range )
Week 1	4.50 ( 0 to 12 )	5.50 ( 1 to 10 )
Month 1	3.00 ( 1 to 10 )	5.00 ( 1 to 12 )

No statistical analysis provided for Lipid Layer Pattern Assessment

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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.

The agreement is:

	The only 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only 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 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Vice President Medical Affairs - Europe
Organization: Allergan, Inc.
phone: (714)246-4500
e-mail: clinicaltrials@allergan.com

No publications provided

Responsible Party:	Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier:	NCT00761202 History of Changes
Other Study ID Numbers:	AGN/OPH/DE/002
Study First Received:	September 25, 2008
Results First Received:	January 12, 2010
Last Updated:	January 12, 2010
Health Authority:	United Kingdom: Research Ethics Committee

To Top