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

Dry Eye Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761202
• Other study ID #: AGN/OPH/DE/002
• Status: Completed
• Phase: Phase 4
• First received: September 25, 2008
• Last updated: October 25, 2013
• Start date: August 2007
• Est. completion date: June 2008

Study information

• Verified date: October 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®
Eyedrops as required, but at least 3 times per day
• Sodium hyaluronate
Eyedrops as required, but at least 3 times per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conjunctival Staining by Lissamine Green	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)	week 1, month 1	No
Secondary	Corneal Staining by Fluorescein	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)	week 1, month 1	No
Secondary	Conjunctival Hyperaemia	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)	week 1, month 1	No
Secondary	Ocular Comfort and Ocular Symptoms on Visual Analogue Scale	Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)	week 1, month 1	No
Secondary	Daily Eyedrop Usage	Average daily eyedrop use	Month 1	No
Secondary	Lipid Layer Pattern Assessment	Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.	Week 1, month 1	No