Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms
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| ClinicalTrials.gov Identifier: NCT00761202 |
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Recruitment Status
:
Completed
First Posted
: September 29, 2008
Results First Posted
: February 4, 2010
Last Update Posted
: November 19, 2013
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Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
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Brief Summary:
This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dry Eye Syndromes | Drug: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE® Drug: Sodium hyaluronate | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Treatment |
| Study Start Date : | August 2007 |
| Actual Primary Completion Date : | June 2008 |
| Actual Study Completion Date : | June 2008 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Eye Care
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Optive Eyedrops
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Drug: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®
Eyedrops as required, but at least 3 times per day
Other Name: Optive™ Eyedrops
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Active Comparator: 2
Hylocomod Eyedrops
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Drug: Sodium hyaluronate
Eyedrops as required, but at least 3 times per day
Other Name: Hylocomod
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Primary Outcome Measures
:
- Conjunctival Staining by Lissamine Green [ Time Frame: week 1, month 1 ]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)
Secondary Outcome Measures
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- Corneal Staining by Fluorescein [ Time Frame: week 1, month 1 ]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)
- Conjunctival Hyperaemia [ Time Frame: week 1, month 1 ]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)
- Ocular Comfort and Ocular Symptoms on Visual Analogue Scale [ Time Frame: week 1, month 1 ]Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)
- Daily Eyedrop Usage [ Time Frame: Month 1 ]Average daily eyedrop use
- Lipid Layer Pattern Assessment [ Time Frame: Week 1, month 1 ]Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years or over
- Contact lens wearer, spectacle wearer or non-spectacle wearer
- Mild to severe dry eye symptoms, defined as OSDI score 13 to 100
- Mild to moderate conjunctival staining in each eye and/or mild to moderate corneal staining in each eye
- Best corrected visual acuity of 6/9 in each eye
Exclusion Criteria:
- Previously used Hylocomod or Optive eyedrops
- Systemic allergy or eye allergy
- Systemic disease which might have an ocular component and/or interfere with contact lens wear
- Autoimmune disease which might have an ocular component and/or interfere with contact lens wear
- Systemic medication which might have eye side effects and or interfere with contact lens wear
- Eye infection or use of eye medication
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761202
Locations
| United Kingdom | |
| London, United Kingdom | |
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Medical Director | Allergan |
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT00761202 History of Changes |
| Other Study ID Numbers: |
AGN/OPH/DE/002 |
| First Posted: | September 29, 2008 Key Record Dates |
| Results First Posted: | February 4, 2010 |
| Last Update Posted: | November 19, 2013 |
| Last Verified: | October 2013 |
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Hyaluronic Acid Ophthalmic Solutions Tetrahydrozoline Carboxymethylcellulose Sodium Adjuvants, Immunologic |
Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents Pharmaceutical Solutions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Nasal Decongestants Vasoconstrictor Agents Respiratory System Agents Laxatives Gastrointestinal Agents |