Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02380248
• Date of registration: 02/03/2015
• Prospective Registration: Yes
• Primary sponsor: Alcon Research
• Public title: Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects
• Scientific title: Clinical Evaluation of Systane® Gel Drops on Corneal Staining in Indian Subjects With Dry Eye
• Date of first enrolment: May 14, 2015
• Target sample size: 207
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02380248
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Sr. Clinical Manager, Global Trial Leadership
• Affiliation: Alcon, A Novartis Division

• Name: Head, CTM, Med Affairs
• Affiliation: Alcon Laboratories Pvt Ltd (India)

Key inclusion & exclusion criteria

Inclusion Criteria:

- Must give informed consent, and be willing and able to attend all study visits.

- Best-corrected visual acuity (BCVA) of = 55 letters in each eye as measured by ETDRS
(letters read method).

- Dry eye in both eyes diagnosed by an ophthalmologist.

- Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

- Women of childbearing potential who are pregnant, test positive on a pregnancy test,
or breast-feeding.

- Any medical condition (systemic or ophthalmic) that may, in the opinion of the
Investigator, preclude the safe administration of test article or safe participation
in the study.

- Any contraindications or hypersensitivities to the study medications or their
components.

- Ocular surgery (of any type, including PRK, LASIK, Epilasik, etc.) or ocular trauma
requiring medical or pharmacological treatment within 1 year of Screening.

- Use of topical ocular prescription or non-prescription medications, RESTASIS or
topical ocular steroids within 14 days of Screening.

- Chronic medications (over the counter, prescription, or vitamins) that have not been
on a stable dose for at least 30 days prior to Screening.

- Contact lens wear within 1 week of Screening and/or unwillingness to discontinue
contact lens wear for the duration of the study.

- Participation in any other clinical trial within 30 days prior to Screening.

- Other protocol-specified exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dry Eye

Intervention(s)

Other: Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops

Primary Outcome(s)

Change From Baseline in Corneal Staining at All Study Time Points [Time Frame: Baseline (Day 0), Day 45, Day 90]

Secondary ID(s)

EXI639-P001 (C-13-040)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02380248