Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining

Dry Eye Syndrome Clinical Trial

Official title:

Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01863368
• Other study ID #: M-12-040
• Status: Completed
• Phase: N/A
• First received: May 23, 2013
• Last updated: July 9, 2015
• Start date: September 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life SciencesGermany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.

Description:

Following a 2-week washout phase with saline eye drops, subjects were randomized to receive either Systane® ULTRA or OPTIVE® for the remainder of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Willing and able to attend all study visits.

• Diagnosis of dry eye, as specified in protocol.

• Uses artificial tears, as specified in protocol.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Poor visual acuity, as specified in protocol.

• Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol.

• Any hypersensitivity or allergy to the investigational products or ingredients.

• Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol.

• Contact lens use within 2 weeks of Screening Visit.

• Other protocol-defined exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• Preservative-free saline solution eyedrops
1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.
• Systane® ULTRA lubricant eyedrops

• OPTIVE® lubricating eyedrops

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)	The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.	Baseline, Day 35	No
Secondary	Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)	The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis.	Day 35	No
Secondary	Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)	The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.	Day 35	No
Secondary	Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)	The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.	Day 35	No