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CompletedNCT01543061Updated Sep 27, 2013

Efficacy Study of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints

A Phase 4 interventional study of OPTIVEtm Plus and No treatment in Contact Lens Related Dry Eye Syndrome, sponsored by Optometric Technology Group Ltd. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-27.

Sponsored by Optometric Technology Group Ltd · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The objectives of the investigation will be to assess the effect of the repeated usage of a new eye drop on the tear film characteristics of silicone hydrogel contact lens wearers with contact lens related comfort problems and to quantify any potential benefit.

02

Conditions studied

  • Contact Lens Related Dry Eye Syndrome
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's planned enrollment of 35 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Optometric Technology Group Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Current silicone hydrogel contact lens wearer
  • Complaints of contact lens related dry eye (Symptoms and reduced comfortable wearing time)

Exclusion criteria

Exclusion criteria:

  • Known allergy or sensitivity to the study product(s) or its components
  • Systemic or ocular allergies
  • Use of systemic medication which might have ocular side effects.
  • Any ocular infection.
  • Use of ocular medication.
  • Significant ocular tissue anomaly
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
35 participants (estimated)

Study arms

  • Active comparator
    New study eye drop

    One month of contact lens wear with use of the Test study eye drops

    Device: OPTIVEtm Plus

  • Placebo comparator
    No Eyedrop

    One month of contact lens wear with no eye drop use

    Procedure: No treatment

  • Active comparator
    BLINK Contacts Lubricating eye drop

    One month of contact lens wear with use of the Control study eye drops

    Device: Blink Contacts® Eye Drops

Interventions

  • DeviceOPTIVEtm Plus

    1 drop in each eye four times a day for a period of 30 (± 3) days

  • ProcedureNo treatment

    One month of contact lens wear with no eye drop use

  • DeviceBlink Contacts® Eye Drops

    1 drop in each eye four times a day for a period of 30 (± 3) days

    Also known as: Blink Contacts®

06

What researchers measure

Primary outcomes

  1. Tear Break up Time

    Time frame: 30 days

Secondary outcomes

  1. Conjunctival staining measurement

    Time frame: 30 days

  2. Tear film evaporation rate

    Time frame: 30 days

  3. Ocular Surface Disease Index questionnaire

    Time frame: 30 days

  4. Comfort, vision and ocular symptoms questionnaire

    Time frame: 30 days

  5. Post wear contact lens deposition and lipid uptake assessment

    Time frame: 30 days

07

Study locations

1 site
  • OTG Research & Consultancy
    London, SW1E 6AU, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01543061
Lead sponsor
Optometric Technology Group Ltd
Collaborators
Allergan
Responsible party
Sponsor
First posted
Mar 2, 2012
Start date
Feb 2012
Primary completion
Sep 2012
Completion
Dec 2012
Last update
Sep 27, 2013

Study contacts

Michel Guillon, PhD
principal investigator · Optometric Technology Group Ltd

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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