Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline
Status
Completed
Conditions
Dry Eye Syndrome
Treatments
Other: Hialid 0.1 Artificial Tears Eye Drops
Other: Unisol 4 Saline Solution
Other: Systane Ultra Lubricant Eye Drops
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
The purpose of this study is to evaluate the ocular retention time of Systane Ultra compared to Hialid and saline.
Enrollment
27 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Diagnosed with mild to moderate dry eye as defined in the protocol.
- Able and willing to follow instructions.
- Other protocol-defined inclusion criteria may apply.
Exclusion criteria
- Any medical condition that may affect the results of the study.
- History or evidence of ocular or intraocular surgery within the past six months.
- History of intolerance or hypersensitivity to any component of the study medications.
- Use of concomitant topical ocular medications during the study period.
- Ocular conditions that may preclude safe administration of the test article.
- Unwilling to discontinue contact lens wear during the study period.
- Participation in an investigational drug or device study within 30 days of enrollment.
- Other protocol-defined exclusion criteria may apply.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
27 participants in 6 patient groups
Systane, Hialid, Unisol
Other group
Description:
1 drop Systane in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit.
Treatment:
Other: Systane Ultra Lubricant Eye Drops
Other: Hialid 0.1 Artificial Tears Eye Drops
Other: Unisol 4 Saline Solution
Systane, Unisol, Hialid
Other group
Description:
1 drop Systane in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit.
Treatment:
Other: Systane Ultra Lubricant Eye Drops
Other: Hialid 0.1 Artificial Tears Eye Drops
Other: Unisol 4 Saline Solution
Hialid, Systane, Unisol
Other group
Description:
1 drop Hialid in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit.
Treatment:
Other: Systane Ultra Lubricant Eye Drops
Other: Hialid 0.1 Artificial Tears Eye Drops
Other: Unisol 4 Saline Solution
Hialid, Unisol, Systane
Other group
Description:
1 drop Hialid in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit.
Treatment:
Other: Systane Ultra Lubricant Eye Drops
Other: Hialid 0.1 Artificial Tears Eye Drops
Other: Unisol 4 Saline Solution
Unisol, Systane, Hialid
Other group
Description:
1 drop Unisol in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit.
Treatment:
Other: Systane Ultra Lubricant Eye Drops
Other: Hialid 0.1 Artificial Tears Eye Drops
Other: Unisol 4 Saline Solution
Unisol, Hialid, Systane
Other group
Description:
1 drop Unisol in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit.
Treatment:
Other: Systane Ultra Lubricant Eye Drops
Other: Hialid 0.1 Artificial Tears Eye Drops
Other: Unisol 4 Saline Solution
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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