Study to Evaluate a Contact Lens Lubricating and Rewetting Drop
Study Details
Study Description
Brief Summary
The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lubricating and Rewetting Drops Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week. |
Device: Lubricating and Rewetting Drops
Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.
|
| Active Comparator: AMO Blink Contacts Lubricant Eye Drops AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week |
Device: AMO Blink Contacts Lubricant Eye Drops
Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2. [At 1 week follow up]
Slit lamp findings for epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded 0 to 4, with 0 = none to 4 = severe. The outcome measure is any finding > grade 2, across abnormalities.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
-
Adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
-
Use a lens care system on a regular basis.
-
Wear their habitual lenses (or be willing to wear lenses) a minimum of 8 hours per day.
-
Willing to use drops 4 times per day.
Exclusion Criteria:
-
Participating in a conflicting study.
-
An active ocular disease, any corneal infiltrative response, or are using any ocular medications.
-
Any scar or neovascularization within the central 4mm of the cornea.
-
Any grade 2 or greater finding during the slit lamp examination
-
Using any systemic or topical medications that will affect ocular physiology or lens performance.
-
Aphakic.
-
Amblyopic.
-
Allergic to any component in the study care products.
-
Have had any corneal surgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bausch & Lomb | Rochester | New York | United States | 14609 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Principal Investigator: Stephanie Su, OD, Bausch & Lomb Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 684E
Study Results
Participant Flow
| Recruitment Details | There were 168 participants enrolled and 166 participants treated. The study was a cross-over study, so the 166 participants received both treatment groups. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Lubricating and Rewetting Drops Then AMO Blink Contacts Lubric | AMO Blink Contacts Lubricant Eye Drops Then Lubricating and Re |
|---|---|---|
| Arm/Group Description | Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week. Lubricating and Rewetting Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week. AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week AMO Blink Contacts Lubricant Eye Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week. | AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week AMO Blink Contacts Lubricant Eye Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week. Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week. Lubricating and Rewetting Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week. |
| Period Title: Overall Study | ||
| STARTED | 83 | 83 |
| COMPLETED | 82 | 82 |
| NOT COMPLETED | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Overall |
|---|---|
| Arm/Group Description | The study was a cross-over study, so the 166 treated participants received both treatment groups. |
| Overall Participants | 166 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
33.4
(9.3)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
120
72.3%
|
| Male |
46
27.7%
|
Outcome Measures
| Title | Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2. |
|---|---|
| Description | Slit lamp findings for epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded 0 to 4, with 0 = none to 4 = severe. The outcome measure is any finding > grade 2, across abnormalities. |
| Time Frame | At 1 week follow up |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 330 eyes evaluable for slit lamp findings in each group. |
| Arm/Group Title | Lubricating and Rewetting Drops | AMO Blink Contacts Lubricant Eye Drops |
|---|---|---|
| Arm/Group Description | Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week. Lubricating and Rewetting Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week. | AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week AMO Blink Contacts Lubricant Eye Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week. |
| Measure Participants | 165 | 165 |
| Measure eyes | 330 | 330 |
| Count of Units [eyes] |
1
|
0
|
Adverse Events
| Time Frame | 2 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events were not coded. Therefore source vocabulary is not applicable. | |||
| Arm/Group Title | Lubricating and Rewetting Drops | AMO Blink Contacts Lubricant Eye Drops | ||
| Arm/Group Description | Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week. Lubricating and Rewetting Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week. | AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week AMO Blink Contacts Lubricant Eye Drops: Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week. | ||
All Cause Mortality |
||||
| Lubricating and Rewetting Drops | AMO Blink Contacts Lubricant Eye Drops | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Lubricating and Rewetting Drops | AMO Blink Contacts Lubricant Eye Drops | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/166 (0%) | 0/166 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Lubricating and Rewetting Drops | AMO Blink Contacts Lubricant Eye Drops | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/166 (0%) | 0/166 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Contact sponsor directly for details.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Bausch Health |
| Phone | |
| susan.harris@bauschhealth.com |
- 684E